Job Description

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Leica Microsystems, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

Shape the Future with Us!

At Leica Microsystems, we have been shaping the future for over 175 years with groundbreaking optical and digital solutions. With a culture rooted in customer focus, innovation, and teamwork, we lead the market in microscopy, imaging, and analysis, unveiling the invisible and empowering our customers to build a better, healthier world.

Joining Leica Microsystems means contributing to scientific discoveries and supporting surgeons in making critical decisions. Our advanced microscopes and AI-based image analysis solutions enable users to gain profound insights into development and engineering challenges. Here, you will work on meaningful projects alongside passionate colleagues, driving progress and pushing the boundaries of what’s possible.

Learn about the Danaher Business System which makes everything possible.

The Senior Quality Engineer, PQE is responsible to ensure the quality of both medical and non-medical products through rigorous inspections, implementation of quality control measures, and identification of areas for improvement. You will address production quality issues, collaborate with cross-functional teams to find root causes, and drive continuous improvement to build high-quality products that exceed customer expectations. The ideal candidate will possess a strong background in engineering or quality assurance, attention to detail, a proactive mindset, and preferably experience in people management.

This position reports to the Senior Manager Quality Assurance and is part of the Production Quality Engineering (PQE) team located in Singapore and will be an on-site role.

In this role, you will have the opportunity to:

• Address production quality issues by identifying problems and collaborating with cross-functional teams to develop solutions for overall product quality improvement.
• Utilize statistical tools to identify trends and patterns for enhancing the production process and ensuring quality.
• Investigate and correct root causes of product failures occurring in the field.
• Conduct periodic production audits to ensure compliance with established policies, procedures, and control plans.
• Participate in lean and continuous improvement initiatives, while adhering to company EHS requirements to prevent injuries and maintain safety.

The essential requirements of the job include:

• Bachelor's degree in Mechatronics, Mechanical Engineering, or Electronics.
• At least 5 years of relevant experience in biomedical or medical device manufacturing.
• Proficient in statistical control methods and QMS 9001; familiarity with ISO13485, USFDA QSR/cGMP, and ISO14971 for medical devices is advantageous.
• Computer literate in MS Office and Lotus Notes.
• Strong analytical, problem-solving skills, and knowledge of lean and investigation tools such as 8D and fishbone diagrams, with a solid understanding of engineering principles, theories, and concepts.

Leica Microsystems, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job.

• Carry out incident investigation, VDR analysis, on board audits / inspections and training as assigned.
• Assist the company with business development, where possible.
• Perform duties of Training Faculty when required.
• Visit and assess vessels for compliance with owners / managers requirements, industry regulations and best practices.
• Under the direction of the General Manager / Team Lead, ensure all assigned jobs are delivered in line with its expectations and ensure quality standards are uniformly maintained.
• Keep up to date with national, regional, and international legislative requirements and practices to support company compliance with all relevant regulations.
• Perform tasks as per the deliverables agreed with the client.
• Interface with vessel operators to ensure vessel performance standards.

Job Description

Role: Quality Engineer (QE)

Position Overview:

The Quality Engineer is responsible for ensuring the quality of construction materials, processes, and workmanship throughout a project. This role involves developing QA/QC documents, monitoring site quality control activities, monitoring compliance with standards, and implementing quality assurance procedures to deliver projects that meet contract, client specifications, international standards, and Singapore regulatory requirements. This role is essential to delivering high-quality, durable, and safe civil engineering projects while maintaining efficiency and minimizing risks.

Key Responsibilities:

1. Take part in developing QA procedures as required by the project Quality Assurance Plan.

2. Develop and/or review QC report templates and checklists as per ITPs.

3. Participate in developing quality training materials per project quality requirements and technical specifications. Conduct quality training for subcontractors’ QC inspectors and site supervisors.

4. Conduct regular checks for site QC activities and QC report completion.

5. Cover day-time site inspections for civil works as per ITPs when it is needed by site situations.

6. Take part in project internal quality audits in accordance with project audit procedures to ensure compliance with company ISO 9001 QMS, and Singapore regulatory requirements. Identify non-conformities and work with project teams to implement corrective and preventive actions.

7. Take part in project external quality audits to subcontractors in accordance with project audit procedures to ensure compliance with subcontract, project specifications, codes, and Singapore regulatory requirements. Identify non-conformities and work with project teams to implement corrective and preventive actions.

8. Regularly monitor project KPIs, and ensure out-of-target KPIs are identified and raised to applicable subcontractors for root cause analysis, in the meantime, report to the QAQC manager.

9. Coordinate with discipline engineers, subcontractors, the client, and third-party inspectors to ensure project quality requirements are met.

10. Take part in preparing mechanical completion documents before commissioning.

11. Prepare the Turnover Package (TOP) at the project ending stage.

Work Environment:

Ø Combination of office and on-site work.

Ø Working overtime may be required, and working at a fast pace.

Requirements for the role:

Ø Degree or Advanced Diploma in Civil Engineering or related engineering field.

Ø At least 6 years of relevant Experience in quality assurance (QA) and QA document development in Singapore for civil engineering projects.

Ø Experience in site quality control (QC) related inspection and tests.

Ø Strong knowledge of construction materials, techniques, and standards (BS EN, SS, ASTM).

Ø Excellent quality problem-solving and analytical skills.

Ø Strong communication and interpersonal skills.

Ø Experience in the CONQUAS process.

Ø Certification in Quality Management (e.g., ISO 9001) is a plus.

Candidates are required to:

• Supervise, monitor, document and enforce factory workers’ hygiene and critical control points of production
• Assist in factory audits
• Handle any employee misconduct or issues relating to food safety and hygiene
• Maintain records and food safety standards
• Handle administrative tasks such as placing orders for factory supplies related to Quality Control and sending samples for lab tests
• Liaise with suppliers and customers relating to quality matters and documentation
• Conduct training for workers

Working hours: 8am - 6pm (Monday - Friday)

Candidates should possess the following skills/knowledge:

• Basic knowledge of food hygiene
• Relevant education in Food Science
• Competent knowledge in Word, Powerpoint and Excel
• Good understanding of GMP, HACCP and ISO22000

Knowledge in FSSC 22000/working in an FSSC 22000 environment is an advantage.

Purpose: To lead in the management of supplier’s quality performance and technical specification compliance to better meet the company’s business goal and requirements (Quality, Logistics, Technology, Cost, Service).

Key Area of Responsibilities:

• Review and approve First Article (FA) Report for product qualification
• Review and approve Supplier Change requests through the Supplier Change Request and Waiver Report submitted by the supplier to manage Change Control (Copy Exact requirement).
• Conduct part buy-off at the supplier site per customer/VDL requirements to ensure compliance before the part is delivered to VDL site.
• Review the Material Review Board (MRB) list to make a disposition on non-conforming parts and take follow-up action (for supplier-related issues).
• Review, approve, and validate actions in the Supplier Non-Conformance Report (NCR)/Corrective Action and Preventive Action (CAPA) Report to ensure the root cause is identified to actions done to eliminate the issue and prevent re-occurrence.
• Review, approve and validate actions in the Supplier 8D Report to identify the root cause and eliminate the issue to prevent re-occurrence.
• Conduct Quality Management System /Technical / Process Audit to qualify; periodic assessment to mitigate risk to Customer and VDL.
• Provide support on the Supplier Quarterly Business Review (QBR) process (Quality-related actions, indices, and feedback) to ensure alignment between critical suppliers and VDL to meet VDL requirements/targets.
• Engage in Continuous Improvement Projects (CIP) with suppliers to improve Quality and prevent Quality issues.
• Review overall supplier Quality status during Weekly Supplier Quality Department meetings to control supplier Quality and mitigate concerns.
• Present updates on Supplier performance to management and the customer focus team at the Customer Performance Forum.
• Provide support on New Product Introduction (NPI) meetings (Supplier Quality-related) to understand customer requirements and translate them to related suppliers.
• Support and participate in the company continuous improvement program.

Qualification & Experiences:

• Diploma/Degree in Mechanical Engineering/Mechatronics or other relevant qualification.
• Minimum 3 years of experience as a supplier quality engineer in the manufacturing industry.
• Certified Quality Engineer preferred
• Team player
• Good problem-solving skills
• Meticulous in details
• Proficient in advanced Microsoft Excel functions
• Good communication skills

Qualification: Degree in Engineering preferably Chemical or Mechanical or Diploma with min 5 years Quality experience.

Job Requirements: Minimum 5 years working experience in manufacturing environment preferably in Quality. Knowledge of ISO 9000, ISO 14001 and ISO/TS 16949 Computer Literate. Able to work independently and a team player.

Reporting Level: Quality Engineering Manager/ Artwork and OF Manager

Duties and Responsibilities:

1.1. To support the Quality Manager to meet the company objectives and goals.

1.2. Manage activities of incoming inspection to assure that materials used meet quality requirements

1.3. Oversee the product inspection activities within the company and QA activities within the department.

1.4. Overseeing outgoing inspections to ensure products meet customer requirements, including 100% firewall activities.

1.5. Developing, reviewing, and approving quality control methods and procedures to ensure that products meet customer specifications

1.6. Conduct training sessions for staff on quality standards, procedures, and best practices.

1.7. Manage and maintain quality documentation; and Prepare and review quality reports, metrics, and key performance indicators (KPIs)

1.8. Handling and managing customer complaints, coordinating with relevant departments for resolution, and ensuring timely responses to customers.

1.9. Prepare and manage corrective and preventive action reports (e.g., 8D reports) or relevant report(s) to customer.

1.10 Develop and initiate quality improvement programs, coordinating with internal departments and external parties (e.g., suppliers) to ensure successful implementation and measurable improvements.

1.11 Implement and uphold quality, environmental, and safety management systems such as ISO 9001,IATF 16949, ISO 14001, and applicable safety regulations. Represent management as Quality Management Representative (QMR) or Environmental Management Representative (EMR) in

these systems' implementation and maintenance.

1.12 Promote quality, environmental awareness.

1.13 Manage the activities of the Document Control Center.

1.14 Ensure that all measuring and test equipment are calibrated and in good condition as required.

1.15 Manage the handling of non-conforming products by stopping processes if necessary and ensuring that deficiencies are addressed and corrected before resuming production.

1.16. Assist the Quality Manager in strategic planning and decision-making and Provide input for setting quality objectives and goals.

1.17 Undertake additional tasks or responsibilities as directed by a superior.

Job Description

1. Respond to new and existing customers for inquiries.
2. Conduct quality testing and communicate product specification issues. Conduct nonconforming material or nonconforming product analysis.
3. Participate in the root cause analysis of nonconforming goods.
4. Follow the instructed corrective actions and preventive actions by superiors.
5. Secure customer formulations.
6. Control QSHE records and documents.
7. Establish formulation and blending procedures as needed.
8. Keep retain samples of products.
9. Validate COA of raw materials received and communicate any issues to the procurement and Plant Manager. Establish, update and issue GHS SDS.
10. Create certificate of analysis (COA) of products.
11. Coordinate sample delivery as required by the customer.

Job Requirements

• Minimum Diploma/Degree in Vhemistry related fields with at east 1 year related experience
• Fresh entry level graduates
• Technical Knowledge : Microsoft Office (Basic)
• Knowledge & Skills on QC Testing

Main Responsibilities:

• Enforce food safety & quality systems (e.g. ISO 22000, GMP)
• Liaise directly with customers on quality / food safety issues, feedback
• Establish & ensure accuracy of information / documents (eg. product specifications) provided to customer
• Establish and improve food safety systems & standard of procedure ( SOP )
• Conduct food safety audits and ensure product consistency
• Work with R&D and Production to ensure smooth execution of new products developed to mass production
• Handle food safety and Halal audits by customers, AVA, MUIS etc Microbial testing knowledge required
• Work with Group QA/QC head to set corporate wide target and focus area
• Develop corporate wide retail product quality monitoring system (e.g. consumer complaint system; market quality monitoring system)
• Support marketing team in customer/consumer quality complaint handling

Job Requirements:

· Degree in Food Technology, Food Science, Chemistry or Microbiology.

· 7 years’ experience in Quality Assurance or Quality Management, preferably in Food Industry.

· Experience in cross countries / regional role with interaction to Senior Supply Chain or Business Management.

· Experience in managing food safety and/or quality issues including direct communication to consumer/customer.

· Knowledge and understanding of applicable legislation and standards across multiple international jurisdictions.

· Good interpersonal and communication skills.

Responsibilities:

• Work within the Quality Group and the Package Team and liaise with all project team members, such as Engineering, SCM Document Control and Vendor Inspection Coordinator etc.
• Participate in review Material Data sheets. development and issuance of Material Requisition/ RFQ.
• Understands and ensure quality requirements in built into the RFQs and POs documents as well as all the package specific Quality Requirements.
• Review the Technical Bid documents submitted by vendor
• Engages in the review and response to the Technical Clarification on Quality related issues
• Issues Quality Bid Technical Evaluation report for each Bid Package
• Participates in PO award recommendation
• Interfaces with the Vendor Inspection Coordinator wherever source inspection is required.

Requirements:

• Degree in Mechanical Engineering.
• Minimum of 5 years’ experience in equipment procurement for oil & gas/ offshore industries.
• Possess CompEx certified (Module 11), ISO 9001:2015 Lead Auditor, NORSOK / PED requirement, ASME / ASTM / API codes, DNV-GL codes and standards and basic knowledge of NDT

Our Addresses and Working Hours:

(Tuas Boulevard Yard)

80 Tuas South Boulevard, Singapore 637051

(Islandwide transport provided)

Mon - Thur: 8:00am - 5:15pm

Fri: 8:00am - 4:30pm

Interested candidates are invited to send us an updated resume with your current and expected salary and earliest availability.

We regret that only shortlisted candidates will be notified.

Please note that your personal data disclosed to Seatrium (SG) Pte. Ltd. and our group of companies, shall be used for the purposes of evaluation, and processing in accordance with our recruitment processes and policies. By providing your personal data, you have consented to the aforesaid purpose under the provisions of the Personal Data Protection Act 2012.

Key Responsibilities

The successful incumbent will support the QA Manager in the following responsibilities.

• Ensure compliance with the Company’s food safety management system, QA standards, customer requirements, certification audits, and regulations for quality and food safety control processes.
• Support the Quality Assurance Manager (QAM) in preparing external and internal audits according to customer standards/contract requirements, and drive cross-functional teams to achieve targeted performance.
• Conduct site inspections to promote continuous improvement and adherence to Standard Operating Procedures (SOPs), hygiene, and food safety practices.
• Manage QA random sampling and microbiological testing for food samples, raw materials, water & ice, hand swabs, and Environmental Monitoring Program (EMP).
• Analyze data and follow up on unsatisfactory test results to identify potential causes of failure, recommend corrective actions for process improvement, and prevent recurrence.
• Prepare documentation related to all export matters in the capacity of Quality Person (QP).
• Develop training materials and conduct food safety trainings for operational staff.
• Review new product artwork to ensure regulatory compliance.
• Assist QAM in food safety incident management, including site investigations, testing, and preparation of incident reports.
• Support QAM in maintaining the ISO 22000/HACCP manual and QA documentation.
• Assist in the supplier approval program (supplier assessment/documentation review).
• Contribute to QA work plans and initiatives aimed at improving QA processes and food safety standards.
• Support Group QA, annual emergency exercises, and ad-hoc catering events as required.

Key Requirements

• Minimum Degree in Food Science/ Technology or other relevant fields.
• Minimum 2 year of QA experience in the food industry.
• Passionate in upholding food safety and possess good knowledge of Food Regulations, SFA requirements, GMP, and food safety management certifications (e.g., HACCP, ISO 22000, GFSI standards).
• Keen learning attitude, proactive, and decisive.
• Detail-oriented and meticulous with competency in report writing and presentation skills.
• Independent, committed and possess strong interpersonal communication skills
• Ability to multi task, handle stress in a fast-paced environment, and meet tight deadlines.
• Excellent interpersonal and communication skills.
• Collaborative and able to work effectively in a team.
• Must be comfortable working in a cold environment.

Job Descriptions :

• Leadership and Coordination: Spearhead the delivery of Quality work scopes ensuring seamless coordination among stakeholders and compliance with applicable requirements. You’ll work alongside functions such as Package Mgmt, H&S, Engineering, Construction, Supply & Expediting, Commissioning, Project Controls, Contract Management, Legal, and Procurement.
• Quality Management: Drive project to completion on time, within budget, and to the highest quality and HSE standards. Develop and maintain project Quality schedules, budgets, and forecasts, contributing directly to Company’s Renewable strategy. Ensure compliance to Project Quality requirements are met.
• Design and execute a comprehensive strategy that integrates quality management with sustainability goals to support growth objectives
• Supervise, coach and engage the Quality team to strive for excellence, to deliver solutions that meet high-level quality standards
• Continuously improve customer satisfaction by handling customer complaints promptly and professionally
• Ensure products meet quality standards before reaching customers.
• Oversee all new product development procedures, ensuring that sustainability considerations and internal controls are integrated from the beginning.
• Risk Management: Effectively manage project risks, specifically those intrinsic to the offshore wind industry, manufacturing, Quality Assurance/Quality Control, and supply chain challenges.
• Ensure that the lessons learned are effectively captured and communicated during the project
• Expected to travel to Batam to monitor and control the construction progress and customer meetings.

Job Requirements :

• Bachelor’s degree or higher in Engineering, Mechanical Engineering, or a related field.
• 5-8 years of experience managing quality of Shipyard and installation. Experience in Quality Assurance and Quality Control for onshore / offshore wind projects, preferably specific to Offshore substation construction
• Proven success in quality and process management, with a track record in quality control and continuous improvement.
• In-depth knowledge of Quality Management Practices and standards such as ISO, APQP, PPAP, FMEA, MSA, REACH, ROHS.

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

We are looking for a QC SME who will be responsible for ensuring the successful implementation and integration of gLIMS at the site by conducting thorough gap assessments and leading the required local process adjustments.

Key Responsibilities

• Perform gap assessments at the process and Standard Operating Procedure (SOP) levels.
• Collaborate with local teams, including MSAT and production, to identify necessary changes to existing processes, documentation, and data.
• Define, coordinate, and track actions to address identified gaps in a timely manner prior to roll-out.
• Develop and update local procedures for Quality and QC as required.
• Lead efforts to consolidate consumables, suppliers, instruments, etc., to reduce data load.
• Oversee data cleansing activities to ensure data integrity and accuracy.
• Manage updates and replacements of QC lab instruments (including firmware updates) to maintain secure system connections.
• Support the Change Manager by providing information, communication, and training to shop floor staff.

Required Qualifications

• Extensive experience in Quality Control and familiarity with gLIMS process descriptions.
• Strong analytical skills to identify local gaps and propose effective solutions.
• Excellent communication and collaboration skills to work with various stakeholders.
• Experience in writing and updating local work instructions and procedures.
• Empowered to make decisions for the site/department

Why join us?

• Generous Leave Policy including Elderly Care Leave to care for aging family members, reflecting our commitment to family wellbeing.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

Purpose: The role is responsible for handling customer quality issues and continuous improvement activities of the Company products and processes. You are required to drive internal departments on quality-related issues to follow up on effective corrective/preventive actions. You will be liaising with the internal team to support QBR, RMA, IFR, MRB, FAI Review and approval with Supplier and customer, In-Process Audit, FA Launch, 8D, SDR, FPY, tracker processes, and communicate between customer and internal team on Quality related matters.

Key areas of responsibilities:

• Lead and drive customer quality CAB meetings to derive root causes and corrective and preventive actions based on 8D methodology
• Perform ad-hoc visits to customer sites to facilitate investigation and improvement proposal
• Develop, drive, and lead the improvement of manufacturing systems and processes to meet and exceed customer expectations
• Lead and drive company-wide continuous improvement projects with relevant Organizations
• Build and drive customer relationships to improve customer satisfaction
• Perform customer quality performance monitoring and reporting to internal management and customer
• Manage the first article process and submit the report to the customer for approval
• Lead cross-functional team to establish the outgoing inspection checklist for NPI to ensure that the product meets customer requirement
• Analyze customer quality performance to identify trends and improvement opportunities
• Perform manufacturing audit

Qualification & Experiences:

• Degree in Mechanical/Mechatronics/Electrical/Manufacturing Engineering discipline
• At least 5 years of working experience, 3 years in dealing with customer quality managers or direct customer facing, related to the manufacturing environment, preferably from the semiconductor, semiconductor equipment industry, electronics, or high-tech instrument industry
• Strong knowledge and practices in 8D, SPC, FMEA, 6-sigma methodology (Certified Black/Green Belt), and change management
• Good understanding of first-article inspection requirements and expectations
• Excellent leadership and effective communicator with all levels of associates and management
• Experienced in Minitab is an advantage
• Experienced QMS auditor

Job description / responsibilities / activities/ tasks:

Interpret project specifications and develop project quality plan in consultation with project manager and Shell Quality Lead,

Implementation of quality assurance and control activities in accordance with the project quality plan including but not limited to:

· Establish Field QC Organization, to manage field QC group and members including assignment of EPCm and/or contractor QC Inspectors. To interview all EPCm and/or contractor QC before assignment to Project

· Coordination with EPCm (optional), other disciplines and contractor’s approval of the Field QC related documents prepared by each Contractor,

· Attend KOM & Pre-Inspection Meeting with EPCm and Contractors depending on criticality of works,

· Review Contractor documents related to quality control (E.g. ITP, WPS, PQR, test packs, NDE procedures) and ensure compliance to the Project Spec’s & applicable Code Standard,

· Organize and lead on-Site quality patrols and audits to ascertain health of Project quality systems, Control of NCR’s & Quality observation Records,

· Verify that all the required inspection and documentation are completed by the contractor / Vendor and issuance of the Inspection Release Notice (IRN) to the contractor / Vendor prior to any Site delivery,

· Perform line checking, punch-listing & killing, witnessing various types of tests such as hydrostatic & pneumatic testing and monitor coordination of Pre-commissioning, flushing activities,

· Final acceptance sign off on quality test packages

Trouble shooting of major QC related issues,

Prepare and conduct Project Lesson Learnt (LL) for projects done,

Carry out any other related duties as required, including temporary assignments in other sections within the MTAC department on site.

Qualifications/Experiences Required

Educational Qualifications:

· Diploma/ Degree in Mechanical Engineering or related discipline

Technical Qualifications:

· Valid Certified Welding Inspector (CSWIP 3.1) or equivalent

· Qualified MOM OPSOC (Supervisor) or equivalent

· ASNT qualification is a bonus

Professional Experience:

· Minimum 20 years of relevant experience in oil & gas, chemical & petrochemical industry in the below fields:

o Project Quality Management Systems

o Brownfield construction

o Civil, Steel Structure, Piping/Pipeline Construction

o Application of Protective Coatings (Organic Coatings, fireproofing)

o Non-metallic piping systems.

· Relevant experience includes:

o Set up and execution of Project Quality Plan

o Workshop and field quality assurance and control

o Leading EPCm and Contractor quality teams in flawless delivery

· Experience in Plant Turnaround Project Quality planning, preparation and execution.

· Conversant with international codes and standards such as ASME II, ASME V, ASME VIII, ASME IX, ASMEB31.1, ASME B31.3, AWS D1.1, API 1104, API 650 & 620, ASTM, SHELL DEPs

The Career Conversion Programme (CCP) (Train-and-Place with Commitment to Hire) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals is a talent development programme aimed at building the next generation of skilled manpower for Singapore’s Biopharmaceuticals manufacturing industry in anticipation of hiring demand.

The training programme consists of 15 months of local attachment with GSK. Due to the nature of the programme, we can only consider Singapore Citizens and Singapore Permanent Residents. For more information, please visit Career Conversion Programmes (CCP) for Individuals

Purpose:

• To be responsible for managing the interactions with third party organisations that supply QA incoming materials and/or services to GSK.
• To manage material release for incoming materials, supplier change notifications and new material management.
• To provide Quality oversight to logistics management and warehouse operations.

Key Responsibilities:

Supplier Management

• Provide QA oversight of Supplier management activities on site to achieve compliance with company policies and government regulations as assigned.
• To participate (Executive 1) and to represent the site (Executive 2) for Supplier Management business processes to drive improvements and share best practises across the GSK Vaccines network.
• Process owner/support supplier complaint process for QA incoming materials. Lodge supplier complaints and ensure suppliers identify the root cause and associated CAPA's to prevent recurrence of supplier quality issues.
• Review and track supplier-related CAPA for timely closure.
• Maintain inspection readiness, conduct supplier assessments for both new and current service providers in a timely manner.
• Maintain the approved supplier listing and audit schedule in a state of compliance and accuracy.
• Assess supplier change notifications in a timely manner and escalate where necessary especially in situations with supply impact.
• Initiate and review deviations/change control/CAPA associated with incoming material.

Executive 1: Minor deviations and CAPA

Executive 2: Minor, major deviations and CAPA

• Work closely with site user and Global stakeholders for Supplier management related matters

QA Raw Material Release and Warehouse oversight

• Support incoming material documentation review and release to recommend and confirm Usage Decision (UD) of raw material
• Ensure that material document file (MDF) is complete and accurate before disposition of material in SAP
• Ensure that system is in place for filing and archival of MDF
• Initiate and review deviations/change control/CAPA associated with incoming material releases.
• Ensure that all deviations/change controls are closed or assessed for impact on the release of the material prior to release the QA-controlled incoming material
• Provide QA oversight to warehouse such as attending warehouse tier, conduction GEMBAs, inspection readiness and warehouse related deviations, CAPAs and change control

Decision Making:

Proposals & Recommendations

• Propose improvements to work processes, with basic awareness of business requirements.
• Deviation investigations and assessments
• In addition for QA Executive 2:
• Able to provide QA oversight on routine situations independently and complex situations with supervision (deviations, changes, system issues, compliance matters)
• Able to manage simple department projects (e.g. continuous improvement) with supervision
• Greater awareness of business requirements and to highlight considerations where there is a need for escalation

Skills:

Professional

• At least University basic degree in a Science or Engineering discipline

Technical

• A good understanding of cGMP regulatory and legal requirements as applied to quality assurance of pharmaceuticals manufacturing
• User experiance with SAP will be prefered
• Ability in handling and organizing multiple workflows

Business

• Ability to apply optimal quality assurance standards to promote a business edge
• Ability to facilitate business activities commpatible to international regulatory environment
• Ability to communicate effectively within the site organization and across the network

Competencies:

• Working knowledge of FDA/EU/ICH/WHO as well as all other relevant reuglatory and technical guidelines
• Possess Analytical and Quality performance mindset
• Demonstrate professional & ethical integrity
• Fluency in the English language
• Demonstrates sense of urgency
• Ability to work both as an individual contributor and as a team player.

Where will I be based?

You will be based at one of our manufacturing site in Singapore near Tuas.

Job Responsibilities:

• Support continuous improvement efforts in QMS.
• Support in root cause analysis and implementation of corrective/ preventive actions for process related concerns.
• Analyze and provide timely respond to customer complaints.
• Interface with Customer and Operations to ensure new product transfer to manufacturing are in accordance with approved requirements.
• Prepare Quality performance metrics and reports.

Requirements:

• Diploma in Mechanical Engineering, Quality, or equivalent.
• Minimum 2 years work experience in Quality Management System in manufacturing environment.
• Good knowledge of ISO 9001. Knowledge of API Q1 is preferred.
• Strong command of English language, both oral & writing.
• Knowledge of metal working industry is preferred.
• Knowledge of risk assessment principles and methods.
• Knowledge of SAP is preferred.
• Positive & proactive attitude.

Job Responsibilities:

• Support continuous improvement efforts in QMS.
• Support in root cause analysis and implementation of corrective/ preventive actions for process related concerns.
• Analyze and provide timely respond to customer complaints.
• Interface with Customer and Operations to ensure new product transfer to manufacturing are in accordance with approved requirements.
• Prepare Quality performance metrics and reports.

Requirements:

• Diploma in Mechanical Engineering, Quality, or equivalent.
• Minimum 2 years work experience in Quality Management System in manufacturing environment.
• Good knowledge of ISO 9001. Knowledge of API Q1 is preferred.
• Strong command of English language, both oral & writing.
• Knowledge of metal working industry is preferred.
• Knowledge of risk assessment principles and methods.
• Knowledge of SAP is preferred.
• Positive & proactive attitude.

KEY DUTIES AND RESPONSIBILITES:

• Lead and support QC team for daily QC activities by ensuring timely analysis, documentation, and review of RM/PM/FP/IPC/Stability and Process validation samples as per predefined standards.
• Write and / or review controlled documentation related to laboratory operations or testing such as SOP's, analytical protocols, analysis reports, forms and validation documents.
• Ensure compliance with FDA/USP/EP/ICH/ChP regulations and internal controlled procedures in the QC Laboratory.
• Ensure readiness of QC Laboratory in internal / external audits.
• Maintain data integrity in Quality Control activities and ensure appropriate traceability.
• Initiate change control documents.
• Lead and participate in stability program, method validations, technical transfer, method transfer and validation / qualification activities at the site.
• Participate in New Product Introduction activities.
• 9. Lead and participate in laboratory investigations. Document laboratory investigation activities or review and approve laboratory investigation reports.
• Participate in site corrective action / preventive action (CAPA) program. Ensure timely completion of all commitments made under QMS.
• Lead and participate in key performance indicators for improving laboratory efficiency, monitoring equipment performance.
• Lead QC Department training program by imparting training to new staff and comply with Analyst Qualification procedure.
• Escalate the quality events, trends as appropriate to QC Head.
• Remain abreast of current regulatory, pharmacopeia and cGMP trends.
• Serve as subject matter expert on laboratory instrumentation and compliance issues.
• Lead the QC team, evaluate competencies, assign responsibilities, monitor performance, counsel and provide guidance. Plan & monitor the training and development requirements, motivate staff appropriately to build a committed, motivated & competent team.
• Participate in personnel decisions (interviewing, hiring, performance appraisals, promotions, termination, staff development, improvement plans) regarding subordinate staff.
• Maintains a safe laboratory environment by implementing recommendations made by EHS.
• Initiate CAPEX for equipment purchases.
• Support in budget preparation for QC Laboratory.
• Any other activities as and when assigned by the Superior.

JOB REQUIREMENTS:

• EDUCATION: Degree in science or related discipline (e.g. Chemistry, Chemical Engineering).
• EXPERIENCE: Minimum 8 years of quality control experience in pharmaceutical manufacturing industry and minimum 2 years of supervisory experience in managing team.

KNOWLEDGE & SKILLS:

• Possess working knowledge of GMP in the pharmaceutical industry.
• Excellent interpersonal and analytical skills, good verbal, and written communication skills.
• Working knowledge of qualification, calibration, and operation of laboratory equipment such as HPLC, GC, FTIR and Dissolution equipment.
• Working knowledge of method development, validation, verification of analytical method.
• Familiarity of 21 CFR Part 11 requirements.

TO APPLY:

Candidates are encouraged to apply this position via email to [email protected]. with the following information in the resume.

· Work experiences and job responsibilities.

· Current and Expected salary

· Reason for leaving.

· Date of availability

· Education background

We regret that only shortlisted candidates will be contacted.

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.

As an Associate I, Quality Control Lab – AS&T you are responsible in planning and establishing robust and effective laboratory systems, state of art equipment/technologies to support the product/method lifecycles. Maintaining laboratory compliance standards to be inspection ready. Drive and promote a continuous improvement culture to improve the quality and efficiency of QC workflow and processes in our Tuas facilities. In this role, a typical day will include:

Responsibilities

• Subject matter expert (SME) for the lifecycle of analytical/microbiological test methods:
  Manage and maintain the lifecycle of analytical and/or microbiological test methods, including method validation, method verification, method transfer, method troubleshooting & improvement, method performance periodic review.
  Develop/draft and execute protocols for method validation, verification, transfer and improvement within project timeline and budget. Create or update test procedure and data sheet. Coordinate and complete change requests.
  Perform data trending and analysis and monitor test method performance. Analyze data to identify unfavorable trends, investigate underlying causes, address issues with relevant stakeholders, implement effective actions and to drive improvement on the method robustness.
  Lead, manage and execute projects of small to medium scale and complexity.
  Review and assess external standard and/or regulatory requirements pertaining to quality control activities and implement necessary changes to ensure compliance.
  Develop Annual Product Quality Review (APQR) sub-reports and ensure timely submission of sub-reports without overdue.
  Site point of contact for global communities/initiatives pertaining to test method lifecycle.
  Provide guidance, coaching and training to the team as required. Conduct training for new or changed test procedures or techniques.

• General responsibilities:
  Meet quality objectives set by management & comply to Alcon, QMS and Safety requirements.
  Timely report non-conformance, out-of-specification, out-of-trend, out-of-expectation events. Lead or assist in root cause analyses for product defects and quality lapses, and take effective actions to prevent recurrence.
  Timely completion of all compliance activities without overdue, including but not limited to non-conformance investigation, OOS, CAPA, effectiveness check, change request, training, periodic review.
  Review/approve records/documents. Maintain integrity, accuracy and completeness of data and records.
  Compile data to support business and performance metrics reporting.
  Support and back up other AS&T projects/activities, including laboratory testing asset lifecycle, stability program, Laboratory Information Management System (LIMS)

• Improve quality and efficiency of QC workflows/processes:
  Drive and promote the continuous improvement culture. Challenge current processes, identify improvements and drive the effort to implement lab system/process while maintaining compliance and reducing human Intervention.

What You'll Bring to Alcon

• Bachelor Degree in Chemistry, Bioscience or Microbiology Engineering Related Study
• Experience with validation, verification, transfer of analytical test methods and/or microbiological test methods.
• 1-3 years experience in pharmaceutical/medical device industry with GMP knowledge.
• Good understanding of the industrial practices and regulatory requirements related to laboratory equipment and computerized systems.
• Experience of working in/with QC laboratory. Understand QC requirements and laboratory processes/workflow.
• Experience in leading or managing project.
• Experience with managing stability studies, metrology equipment, data analysis or data analytics is an added advantage.
• Certified greenbelt is an added advantage.

Why Join Us:

• Opportunity to work with a leading global medical device company.
• Collaborate with a diverse and talented team in a supportive work environment.
• Competitive compensation package and comprehensive benefits.
• Continuous learning and development opportunities.

Job description

Non-Destructive Testing (NDT) technicians examine structures,vehicles, and products for flaws and structural weaknesses usingnon-destructive testing techniques. They conduct material tests,interpret the results, and generate reports on their findings.

Requirements

Bachelor's degree in mechanical engineering, structural engineering,or a similar field.

Relevant NDT certification.

10+ years' experience as an NDT technician.

Advanced knowledge of NDT technologies including ultrasound,infrared, and radiographic.

1. Training Program Strategy and Development

• Develop and implement a comprehensive global training strategy aligned with business objectives.
• Design and oversee the development of training programs for various departments, including GMP, quality, regulatory etc.
• Ensure training materials are up-to-date, engaging, and compliant with regulatory requirements.
• Implement innovative training methodologies, including e-learning, virtual reality, and blended learning approaches.
• Select and manage external training vendors and consultants.
• Ensure external training solutions meet company standards and regulatory requirements.

2. Regulatory Compliance

• Ensure all training programs meet GxP requirements and other relevant regulations
• Stay informed about industry trends and regulatory changes affecting pharmaceutical training
• Participate in regulatory inspections and audits related to training

3. Quality Management

• Integrate training initiatives with the company's quality management system
• Develop and maintain SOPs related to training processes
• Implement quality metrics to measure the effectiveness of training programs

4. Learning Management System (LMS) Oversight

• Oversee the implementation and management of the company's LMS
• Ensure proper documentation and tracking of all training activities
• Utilize LMS data to generate reports and analytics for continuous improvement

5. Cross-functional Collaboration

• Collaborate with leadership team to identify and address organizational training needs
• Work closely with Quality Assurance, Regulatory Affairs, Human Resources, and other departments to align training initiatives
• Collaborate with subject matter experts to develop technically accurate training content

6. Budget and Resource Management

• Manage the training department budget
• Lead and mentor a team of training management quality professionals across multiple sites
• Allocate resources effectively across global training initiatives

7. Continuous Improvement

• Regularly assess the effectiveness of training programs and implement improvements
• Stay updated on adult learning theories and innovative training technologies
• Establish forums for knowledge sharing and best practice exchange across global sites

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

We are looking for a QC Lab Subject Matter Expert (SME) responsible for the precise setup and loading of master data into gLIMS, in compliance with global guidelines and data principles. This role is vital to maintaining data integrity and developing local support frameworks for continuous data management.

Key Responsibilities

• Execute local master data setup and loading in accordance with global guidelines and data principles.
• Populate the global LIMS system with all required initial master data, including consumables, sampling plans, specifications, parameter lists, test methods, and LES templates.
• Perform local data cleansing to ensure the quality and accuracy of the data.
• Create local work instructions to outline the implementation of global processes at the site level.
• Potential opportunity to transition into a permanent position within the local LIMS Office, offering continuous master data support.

Required Qualifications

• Experience in data management and familiarity with master data setup and loading processes.
• Strong attention to detail and analytical skills to ensure data accuracy and quality.
• Ability to develop clear and concise local work instructions.
• Knowledge of QC lab operations and related data requirements.
• Proficiency in using LIMS or similar data management system.

Why join us?

• Generous Leave Policy including Elderly Care Leave to care for aging family members, reflecting our commitment to family wellbeing.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

Supplier Scouting (20%)
- Support potential supplier scanning.
- Support project documentation and presentation.
- Liaise with various departments/divisions on information gathering.
- Research of free trade agreements within ASEAN.

System Data & Contracts Maintenance (30%)
- Support in ensuring data quality on various purchasing tools.
- Prepare contract documents with suppliers and route for signatures.

Purchasing Support (20%)
- Provide support to other business functions with regards to enquiries about pricing, master data 
maintenance.
- Ensure documents / approvals are in place for Mitigation checks.
- Preparation and sending of mass communications to suppliers.

Purchasing Quality (30%)
- Support team members in the ISIR by checking documents for accuracy and requesting technical 
information (test reports, drawings) from suppliers.
- Create and implement Engineering Change Notifications for the ASEAN region to approve changes of 
products, manufacturing processes, materials or packaging.
- Support in releasing new products and maintaining related internal processes and systems.
- Assist investigations of customer complaints.
- Update system for certificates, audit reports, etc.
- Assist problem solving with suppliers.

Our Quality group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

WHAT YOU WILL DO

Reporting to Senior Manager, Quality Control, you will be responsible for, but are not limited to:

1) Provide change control oversight for Supplier, Manufacturing, Engineering, Warehouse, Incoming Laboratories and Finished Product Laboratories in Pharm or API plants.

2) Provide Quality Operation related impact assessments for change controls. 3) Review and approve supplier, manufacturing, warehouse, facilities, utilities and analytical change controls.

4) Plan, material control for the incoming material and final product release which are impacted by change controls.

5) Review and approve validation protocols, reports and other validation related documents for manufacturing equipment’s, HVAC & utility systems, lab chambers.

6) Review and approve validation documents in compliance with validation requirements.

7) Partner with other site QA and change owner / project lead to complete the change control/project on time.

8) Support site management in continuous improvement efforts in streamlining change control practices for efficiency, consistency and compliance, e.g. Accelerate or Hoshin.

9) As a subject matter expert, be able to respond to enquiries related to QA and projects and approaches during internal and external audits and inspections, and work on audit responses and follow-up actions as needed.

10) Any other duties assigned by the manager.

WHAT YOU SHOULD HAVE

To be successful in this role, you should have good knowledge on cGMP, GDP and Quality Assurance and change control. Be passionate about teamwork and knowledge sharing, and proactive on continuous improvement. Other pre-requisites and attributes include:

1) Possess a Bachelor’s degree in Chemistry/Chemical Engineering or related Sciences, with a minimum of 3 years of experience in QA position in pharmaceutical or related industry.

2) Good knowledge and understanding of GMP and data integrity requirements. Good coaching, communication and interpersonal skills.

3) Demonstrate the ability to actively seek opportunities to continuously improve and simplify processes and procedures.

Other Personal Attributes:

• Self-motivated
• Independent
• Team Player
• Highly Approachable

WHAT YOU CAN EXPECT

• Limitless opportunities across various areas in Manufacturing; well-structured career path
• A state-of-the-art facility that delivers solution to its customers world-wide

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.

As an Associate I, Quality Control Lab – AS&T you are responsible in planning and establishing robust and effective laboratory systems, state of art equipment/technologies to support the product/method lifecycles. Maintaining laboratory compliance standards to be inspection ready. Drive and promote a continuous improvement culture to improve the quality and efficiency of QC workflow and processes in our Tuas facilities. In this role, a typical day will include:

Responsibilities

• Subject matter expert (SME) for laboratory testing asset lifecycle and product stability program:
  Manage and maintain laboratory testing asset (LTA) lifecycle, including selection, procurement, qualification, performance review, re-qualification and retirement of LTA.
  Develop protocols/procedures, execute qualification and implementation of laboratory testing assets and systems, and prepare reports accordingly within project timeline and budget. Coordinate and complete change requests.
  Determine and implement optimal approach for laboratory equipment calibration, maintenance and operation. Ensure laboratory infrastructure and equipment function as intended.
  Govern the lifecycle of stability program. Responsible for protocol & report writing and data trending & analyses. Provide technical expertise pertaining to stability studies and requirements.
  Perform equipment troubleshooting. Investigate underlying causes, technical faults and issues pertaining to laboratory equipment, method or practices, and take necessary actions to resolve the problems.
  Lead, manage and execute projects of small to medium scale and complexity
  Review and assess external standard and/or regulatory requirements pertaining to quality control activities and implement necessary changes to ensure compliance.
  Develop Annual Product Quality Review (APQR) sub-reports and ensure timely submission of sub-reports without overdue.
  Site point of contact for global communities/initiatives pertaining to stability program and laboratory testing assets.
  Provide guidance, coaching and training to the team as required. Conduct training for new or changed test procedures, equipment or systems.

• General responsibilities:
  Meet quality objectives set by management & comply to Alcon, QMS and Safety requirements.
  Timely report non-conformance, out-of-specification, out-of-trend, out-of-expectation events. Lead or assist in root cause analyses for product defects and quality lapses and take effective actions to prevent recurrence.
  Timely completion of all compliance activities without overdue, including but not limited to non-conformance investigation, OOS, CAPA, effectiveness check, change request, training, periodic review.
  Review/approve records/documents. Maintain integrity, accuracy and completeness of data and records.
  Compile data to support business and performance metrics reporting.
  Support and back up other AS&T projects/activities, including test method lifecycle, stability program, Laboratory Information Management System (LIMS).
• Improve quality and efficiency of QC workflows/processes:
  Drive and promote the continuous improvement culture. Challenge current processes, identify improvements and drive the effort to implement lab system/process while maintaining compliance and reducing human Intervention.

What You'll Bring to Alcon

• Bachelor Degree in Chemistry, Bioscience or Microbiology Engineering Related Study
• Experience with laboratory equipment qualification, maintenance and troubleshooting, and computerized system validation.
• 1-3 years experience in pharmaceutical/medical device industry with GMP knowledge.
• Good understanding of the industrial practices and regulatory requirements related to laboratory equipment and computerized systems.
• Experience of working in/with QC laboratory. Understand QC requirements and laboratory processes/workflow.
• Experience in leading or managing project.
• Experience with managing stability studies, metrology equipment, data analysis or data analytics is an added advantage.
• Certified greenbelt is an added advantage.

Why Join Us:

• Opportunity to work with a leading global medical device company.
• Collaborate with a diverse and talented team in a supportive work environment.
• Competitive compensation package and comprehensive benefits.
• Continuous learning and development opportunities.