• Well Established Company
• Basic $4000 - $4800 + AWS + Variable Bonus
• Excellent Welfare and Benefits + Career progression
• Working location: East
• Working day: Monday to Friday
• Working hours: 8.30am to 6pm

Job Responsibilities:

• Responsible for quality issues arising from production and customer feedback, and collaborate with the production tea to address internal process issues and implement corrective actions to resolve customer complaints with proper documentation
• Implement the quality inspection standards, on incoming, in process and outgoing inspections, and provide QA inputs to production to resolve quality-related issues at in-process and final inspections
• Responsible for timely closure of Corrective and Preventive Actions (CAPA), non-conformance investigation report and customer complaints and, publish reports on quality performance
• Lead the Material Review Board (MRB) meeting involving members from production, engineering and quality departments to conduct root cause analysis, address quality issues, implement corrective actions and review its effectiveness
• Lead the team of QC inspectors in the inspection of parts for conformity in accordance with relevant drawing requirements
• Perform any other duties, as assigned

Job Requirements:

• Minimum Diploma or Degree in Precision Engineering, Quality Management or Mechanical Engineering with 2 years of working experience in quality engineering or manufacturing

Candidates are encouraged to apply this position via Apply Now button 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.

LIONG ZHAO GUAN (R22107632)

EA Recruitment Pte Ltd

EA License No: 21C0492

KEY DUTIES AND RESPONSIBILITES:

1. 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.

1. Write and / or review controlled documentation related to laboratory operations or testing such as SOP's, analytical protocols, analysis reports, forms and validation documents.
2. Ensure compliance with FDA/USP/EP/ICH/ChP regulations and internal controlled procedures in the QC Laboratory.
3. Ensure readiness of QC Laboratory in internal / external audits.
4. Maintain data integrity in Quality Control activities and ensure appropriate traceability.

6. Initiate change control documents.

1. Lead and participate in stability program, method validations, technical transfer, method transfer and validation / qualification activities at the site.
2. Participate in New Product Introduction activities.

9. Lead and participate in laboratory investigations. Document laboratory investigation activities or review and approve laboratory investigation reports.

1. Participate in site corrective action / preventive action (CAPA) program. Ensure timely completion of all commitments made under QMS.
2. Lead and participate in key performance indicators for improving laboratory efficiency, monitoring equipment performance.
3. Lead QC Department training program by imparting training to new staff and comply with Analyst Qualification procedure.
4. Escalate the quality events, trends as appropriate to QC Head.
5. Remain abreast of current regulatory, pharmacopeia and cGMP trends.
6. Serve as subject matter expert on laboratory instrumentation and compliance issues.
7. 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.
8. Participate in personnel decisions (interviewing, hiring, performance appraisals, promotions, termination, staff development, improvement plans) regarding subordinate staff.
9. Maintains a safe laboratory environment by implementing recommendations made by EHS.
10. Initiate CAPEX for equipment purchases.

20. Support in budget preparation for QC Laboratory.

21. 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.

· Perform incoming, in-process and outgoing quality control activities

· Liaise with customers pertaining product specifications and quality issues

· Update quality standards regularly in order to conform to customer’s requirements

· Perform in-coming, in-process and final QC daily activities

· File and update QC testing records or reports

· Review and verify daily routine QC results

· Liaise with Logistic Coordinator to arrange for outgoing shipment activities

· Report abnormalities to QA Supervisor

· Prepare quality related reports

· Take part in ISO 9001:2015 IQA activities

Any other duties and responsibilities assigned by the Company from time to time

Physically Fit, able to carry at least 10kg machine parts

Work Place : Pasir Ris (2 weeks training @ Woodlands)

Working Day : 5.5 days

Working Hour : 8.30am to 6pm, 8.30am to 12.30pm

OT available

Job Scope

• Responsible to review and approve master batch records and subsequent batch records
• Review and approve cleaning records and procedures and ensure compliance with set
• Review and approve GMP documentation Ensure adherence to quality procedures, regulatory requirements and cGMPs.
• Review and approve deviations according to the site procedures
• Handle product complaints.
• Ensure complaints are investigated thoroughly with CAPAs effective to prevent recurrence.
• Coordinate with cross-functional team to prepare Annual Product Reviews, discuss trends and atypical observations and recommend improvement actions.
• Conduct internal and external audits
• Maintain inspection readiness and support inspections from regulatory agencies and customers.
• Actively participate in GMP walk downs to ensure site operation and facility maintained in inspection ready state.
• Support the maintenance of validated stated of GMP systems and processes.
• Facilitate and prepare regulatory submissions and attend to regulatory queries in a timely manner

Requirements

• Min Degree in Science / Chemical Engineering or equivalent with relevant pharmaceutical experience.
• Minimum 3 relevant years of experience in QA/QC and GMP Compliance
• Familiar with manufacturing operations applications; six sigma and lean principles and process improvement tools.
• Thorough knowledge of GMP compliance regulations, ICH Q7a Guidelines, Good Documentation Practices and other applicable regulations.
• Proven track record of continuous improvement in quality operations or manufacturing.

All qualified applicants, please send in your resume to: [email protected]

Alex Goh Hock Leong (R1763413)

Recruit Express Pte Ltd | Company Reg. No. 199601303W | EA License Number: 99C4599

We are looking for one technically strong and motivated Manager to support the Assurance R&Q Independence Office.

How will you value-add?

• Provide consultation advice to professionals from various Lines of Service, who seek input for a variety of personal, system and engagement-related independence queries
• Conduct various independence compliance activities such as:
  1. Personal independence compliance testing
  2. Run the Annual Compliance Confirmation activity
  3. Data quality reviews
• Assist in management of independence systems
• Provide support in collation of information and statistics for local, global and regulatory reporting purposes
• Develop relevant independence practice aids, templates and training materials to aid professionals in the firm in complying with independence requirements
• Project manage global or local initiatives as required

About you

• Audit experience preferred
• Have good project management skills
• Possess high level of accuracy and attention to detail
• Have strong analytical & problem-solving skills
• Enjoy meeting people and have the confidence and maturity to deal with all levels of staff
• Has the willingness to learn and deliver timely and quality results

We are seeking a highly skilled and experienced Software Quality Assurance (QA) Lead to oversee the testing and quality assurance efforts for our web application projects. The ideal candidate will ensure the delivery of high-quality software by implementing robust testing strategies, managing a team of QA engineers, and collaborating with cross-functional teams to meet project goals and timelines.

Role & Responsibilities:

• Develop and implement QA strategies, test plans, and scripts for web and mobile applications.
• Lead and mentor a QA team, fostering collaboration with development and other stakeholders.
• Oversee all phases of testing, including functional, regression, performance, and security testing.
• Manage manual and automated testing efforts across multiple platforms (PC/Android/iOS).
• Identify and resolve software defects, collaborating with development teams to improve processes.
• Drive the adoption of automation testing frameworks and tools, optimizing test environments.
• Ensure compliance with security, accessibility, and regulatory standards.
• Promote a quality-focused culture throughout the development lifecycle.

Ideal candidate:

• 5+ years in software quality assurance, including 2+ years in a lead role.
• Strong understanding of web application architecture, testing methodologies, and SDLC.
• Experience with QA tools (e.g., Selenium, JIRA, Postman) and automation tools (e.g., Katalon, pCloudy).
• Familiarity with CI/CD pipelines, Agile/Scrum, and DevOps practices.
• Knowledge of performance testing tools (e.g., JMeter, LoadRunner) and scripting languages (e.g., Python, JavaScript).
• Hands-on experience with mobile and Svelte-based app testing frameworks.
• Strong leadership, problem-solving, and communication skills.
• Familiarity with Linux, Windows, Amazon Cloud, and EKS.

Objectives of the position:

This role is for the Customer Quality Support for Company’s product distribution where Customer’s feedback & Product Quality requirements / issues are handled. The person will be responsible to handle Customers requirements such as complaints, test data & other technical information as requested. Customer complaints handling will also include the necessary communication with all the stake holders (Customer, Supplier, CS, PP, SVM, LOG). Knowledge in cable testing and specification requirements will be required to understand Customer complaints (technical & logistics).

Key Responsibilities:

1. Manage Customer complaint processes such as acknowledgement of the complaint, updating into SAP, keeping track of the complaint, closure of the complaint & summarizing for monthly reporting. Proper handling of customers’ needs by providing accurate and timely information on enquiries related to cable standards, test reports and handling of customer complaints.

2. Track supplier quality by means of in-coming inspection when required or arise from Customer complaints. Update results in SAP system and release inspected lots according to the usage decision defined. To generate supplier CAR and track for corrective action by liaising with the supplier.

3. Familiar with and comply to international cable testing standards and procedures. Contribute to achieving company & department KPIs through due diligence, duty of care & personal accountability for Quality assurance in all tasks.

4. Liaising with relevant departments to effectively close the Customer complaints

5. Maintain records in SAP

6. Operate Laboratory test equipment when required

7. Assist Customer’s Technical enquiries e.g Product Test Report, RoHS, REACH, CE

8. Supplier claim processes and 8D report.

9. Prepare and issue Customer Test Certificates & COC

10. Assist in other day to day activities related to QA department as assigned by Superior.

Skills & Qualification:

▪ Min. Diploma or Degree in Engineering (Electronics / Electrical) or equivalent

▪ Min. 2 years’ experience in electrical / electronic product testing and qualification. Training will be provided.

▪ Knowledge in ISO 9001 : 2015 QMS standard.

▪ Must be able to operate lab equipment (calliper, visual scope, resistance checker, High voltage tester).

▪ Prior experience in SAP system is required for this role. Knowledge of cable product testing is an added advantage.

▪ Good written and communication skills

▪ Good customer handling skills and able to communicate to all levels in the organization

▪ Proficient in Microsoft Words and Excel

▪ Addresses present issues immediately and independently

▪ Possess self-confident and willing to share opinions and expertise in discussions

▪ Anticipate potential problems and takes action to avoid crisis

▪ Provide support to colleague in the Department and work as a team to achieve Department goals and targets

Mon to Fri 8.30am - 5.30pm

Objectives of the position:

This role is for the validation of Customer technical requirements by means of inspection of In-coming goods and release lots in SAP with defined usage decisions. Testing of ISIR samples (type test) for product approval process (power, control & data cable) with compliance to company standards and verify compliance to the international cable standards e.g. EN / IEC requirements. Understanding of each testing standards and be able to communicate the requirements to respective parties including suppliers. Establish test specification to be followed by suppliers. To be able to operate all laboratory equipment in the process of cable type testing. Keep track of product approvals and Company's approved suppliers’ performance monitoring to ensure continuous product compliance to the intended specification. Corrective and preventive action process with supplier with CAR logging and follow-up for effective closure of complaints and issues related to product quality.

Knowledge in product testing and certification will be an added advantage.

Key Responsibilities:

1. Validate product quality conformance by conducting In-coming inspection and type testing for cable & accessories, include updating into SAP.

2. To be able to operate Laboratory test equipment for cable testing and accessories inspection

3. Understand international cable testing standards and inspection requirements with compliance to internal ISO procedures. Prepare test specification with detailed inspection requirement to be followed by the supplier.

4. Prepare and issue Customer test reports, certificates & COC

5. Track supplier quality by means of in-coming inspection or arise from Customer complaints. Update results in SAP system and release inspected lots according to the usage decision defined.

6. To generate supplier CAR and track for corrective action and effective closure of CARs by liaising with the supplier.

7. Liaising with relevant departments including suppliers to effectively close the CAR issued for Customer complaints or CAR’s which arise from internal findings (Z2 & Z8).

8. Maintain inspection records in SAP, determine skip lot and setup inspection requirements in SAP.

9. Assist Customer’s Technical enquiries e.g. Customer letter, RoHS, REACH & CE

10. Understand and comply with relevant ISO procedures, work instructions and corporate directives

11. Assist in other day to day activities related to QA department as assigned by superior.

12. Contribute to achieving company, department and personal KPIs through due diligence, duty of care & personal accountability for Quality assurance in all tasks.

Skills & Qualification:

▪ Min. Diploma or Degree in Engineering (Electronics / Electrical) or equivalent

▪ Min. 2 years’ experience in electrical / electronic product testing and qualification.

▪ Knowledge in ISO 9001:2015 QMS standard will be added advantage.

▪ To be able to operate lab equipment e.g. calliper, visual scope, resistance checker, High voltage tester etc.

▪ Prior experience in SAP system and knowledge of cable product testing is an added advantage

▪ Good written and communication skills

▪ Good customer handling skills and able to communicate to all levels in the organization

▪ Proficient in Microsoft Words and Excel

▪ Addresses present issues immediately and independently

▪ Possess self-confident and willing to share opinions and expertise in discussions

▪ Anticipate potential problems and takes action to avoid crisis

▪ Provide support to colleague in the Department and work as a team to achieve Department goals and targets

Responsibilities (include but are not limited to):

· Work with the Manufacturing department as a production area Quality Assurance representative

· Coordinate and facilitate Quality Assurance related production and production related activities

· Ensure timely issuance of production records, procedures and labels

· Ensure timely assessment and closure of discrepancies, Deviations and Change Controls

· Review batch-related documentation, and ensure resolution of issues to release product

· Communicate lot disposition pending issues to Management

· Ensure approval and timely delivery of Final Product

· Ensure that products are manufactured in compliance with regulatory and GMP guidelines

· Review and approve Manufacturing and Validation documents for Regulatory and Kite compliance

· Review and approve Manufacturing Production Records

· Compile and verify all batch related documents into a Final Product lot disposition package

· Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues

· Review and disposition disposable raw materials and components for GMP use

· Review equipment and facility technical and investigation reports

· Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies

· Gather metric information for use in continuous improvement of areas of responsibility. Report to management as needed.

· Perform other duties as required

Requirements:

• Min Diploma / Degree in Chemical Process Technology, Foodscience, Biotechlonogy, Biology, Biomedical Sciences, Science or its equivalents
• No Experience Needed, Full training/ on the job guidance will be provided
• Able to start immediately

If you are interested in any of the positions, do kindly drop your most updated resume to [email protected] (Attn: QA Specialist)

Thank You.

Leon Leong De Cong
R1551708

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599

Quality Assurance Manager (Biopharma/CBD/1 Year Contract)

Role Purpose:

The Responsible Person, Quality Assurance Manager Australia and New Zealand, will work collaboratively with relevant stakeholders to implement & maintain the local Australian and New Zealand QMS and will work with internal & external stakeholders to ensure quality requirements are met for organisation products, throughout the distribution network, and within Australia and New Zealand, all the way to patients.

Key Responsibilities:

• Establishes and maintains the Quality Management System in Australia and New Zealand to ensure that it meets local regulatory and industry standards and organisation expectations.
• Support maintenance of relevant licenses.
• Manages local process of change control, deviation, CAPA, complaint management and supplier management.
• Manages local Quality Management Review process.
• Participates in organisation’s Quality Escalation process for critical quality issues, and regulatory compliance issues.
• Ensures up to date organograms, training curricula pertaining to GMP/GDP, training records, CVs, and Job Descriptions are in place for local affiliate personnel working on quality/distribution matters.
• Establishes and maintains the Affiliate Quality Manual and GMP/GDP procedural documents.
• Establishes and maintains the Quality Agreement with 3PL/4PL and local GMP/GDP related suppliers/service providers, as required.
• Reviews Annual Product Quality Reports (if applicable)
• Ensures shipping conditions match the product license/product label particulars and transporters are appropriately qualified.
• Ensures premises and/or equipment used are reviewed regularly to ensure they are adequate to allow the handling, storage, and distribution of medicinal products in a manner that ensures the maintenance of product quality.
• Supports Customer Services with enquiries of a GDP nature such as delivery issues, transportation conditions, disputes, etc.
• Working with 3PL/4PL, provides guidance on supply related issues.
• Arranges authorized relabeling/repackaging in cooperation with 3PL/4PL (where applicable)
• Supports the management of quality and distribution complaints.
• Supports the investigation of fraudulent and counterfeit medicinal products.
• Manages product return and destruction.
• Manages local recalls and participating in supplier’s recall challenge or perform local mock recall, as needed.
• Qualifies and manages local 3PL/4PL and supports audit of 3PL/4PL.
• Qualifies and manages local GMP/GDP related suppliers/service providers, auditing and approving these according to local requirements.
• Assure customers validations and adequate records compliance to organisation QA requirements are established and maintained for all local distributors/customers.
• Collaborates with RA to support inspections and audits.
• Manages the Affiliate self-inspection program.
• Supports audit of distributor (where applicable).
• Collaborates with RA to implement activities for new product launch and product life cycle management.

Knowledge, Experience & Skills:

• Highly organized individual with a strong work ethic and ability to work flexibility and independently.
• Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Distribution Practices (GDPs) and knowledgeable about the specific requirements for Australia and New Zealand.
• Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.
• Demonstrates proficiency in Quality Systems processes (Deviation, CAPA, Change Control, Complaints, etc.)
• Demonstrates a knowledge of regional/local regulatory requirements and industry standards.
• Demonstrates strong verbal, written, and interpersonal skills in English.
• Demonstrates proficiency in Microsoft Office applications, particularly, WORD, Excel, PowerPoint, and Teams. Familiarity with technology platforms such as Veeva Vault, SAP ERP, etc.
• Working knowledge of Risk Management tools (e.g., Failure Mode Effects Analysis (FMEA) is preferred.

Typical Educational Experience & Competencies

• Bachelors’ degree and 7+ years of relevant experience in a GMP or GDP environment-related field
• Masters’ degree and 5+ years of relevant experience in a GMP or GDP environment related field.
• Ability to work on own initiative as well as display strong teamwork skills.
• Demonstrates clear personal responsibility for own work, in terms of both the quality of the work and the manner in which it is performed. ‘
• Ability to support change and respond to change requirements by continually striving to improve working processes and systems, consistent with the organisational strategy.

EA License No. 01C4394 • RCB No. 200007268E •EA Registration No. R22109454 Malcolm Lee Jun Hao

By sending us your personal data and curriculum vitae (CV), you are deemed to consent to PERSOLKELLY Singapore Pte Ltd and its affiliates to collect, use and disclose your personal data for the purposes set out in the Privacy Policy available at https://www.persolkelly.com.sg/policies. You acknowledge that you have read, understood, and agree with the Privacy Policy.

As a Non-Volatile Memory Quality & Reliability Assurance (NVMQRA) Engineer at Micron Technology, you will be responsible for performing formal Failure Analysis of customer reported failing devices via the Returned Material Authorization (RMA) process. You will be required to summarize lab analysis results at the electrical and physical level to identify root cause and establish an associated containment plan. In this role, you will have the opportunities to collaborate with various engineering and manufacturing stakeholders to evaluate and review Corrective Actions /Preventive Actions. You will provide documentation of the RMA findings and oversee the final customer report till closure. In addition, for the senior role, you will be asked to provide guidance and lead the team when solving complex unplanned deviations reported by our customers. Project management skills are necessary and the ability to make critical decisions that directly translate to quality and timely completion of the project is highly desirable. You will also be required to spearhead the sustaining efforts and keeping up to date on new product knowledge, as well as developing and mentoring new talents.

Responsibilities and Tasks

Perform Failure Analysis of Customer Returns

• Understand customer complaint of the memory component failure
• Initiate communication with Micron Customer-facing team for further details on customer complaint, requesting additional questions to provide best opportunity for successful analysis
• Perform bench level analysis including initial data image analyis/examination
• Perform Automated Test Equipment (ATE) analysis and interpret results
• Work with the appropriate engineering teams (e.g., PE, PYE) to perform detailed fault isolation when electrical failure has been confirmed
• Summarize findings and submit for physical failure analysis (PFA).

Provide FA Reports for Micron Customer Facing Team for Communication to External Customers

• Summarize analysis at electrical and physical level into customer friendly formats.
• Work with the appropriate manufacturing Global Quality teams through the appropriate request systems (example: GPSS) for Root Cause and/or Corrective Action and a containment plan
• Identify potential risk to external customers
• Communicate with respective BU (Business Unit) on potential impact to customers
• Communicate FA updates through interim reports or during scheduled meetings with the customers.
• Provide formal FA Report with findings

Sustain Knowledge of Device Capabilities and Characteristics

• Keep up to date with latest Fab/ASM process technology
• Understand datasheet specifications for each device and the differences from previous technode for NOR * NAND product family
• Comprehension of qualification data and potential impact to customer operation
• Stay up-to-date on common customer applications and usage model
• Partnering with customer support team to resolve ongoing customer issues

Qualifications and Experience

• Excellent verbal and written communication skills in English. The ability to communicate clearly and concisely both verbally and in writing is critical in this role.
• Good organization skills and ability to multitask and coordinate between multiple issue at any given time.
• Ability to work effectively in cross-functional teams and handle pressure situations in a professional manner
• Excellent problem-solving and analytical skills with strong attention to details.
• Familiarity with NexTest /Teradyne bench analytical tools, scripting in linux console will be an added advantage.

Candidates with 2-3 years of experience in the semiconductor industry as Product or QA engineer are preferred. Relevant experienced candidates will be considered for the Senior Role.

Education

A Bachelor or Masters Degree in Electrical Engineering or similar field of study.

• Position: Quality Assurance QA/QC Engineer (MUST BE from Marine Engineering)
• Location: North Bridge Road (Walking distance from Fort Canning MRT Station)
• Working hours : 5 days / Monday - Friday - 9.30am -5.30pm
• Salary (Commensurate with experience): Basic up to $ 3700 + AWS + 14 days Annual Leave
• Duration : Permanent
• Industry : Global leader in Marine Lifting Equipment

Main Responsibilities:

• Perform inspection of incoming products, materials or customer items according to job project requirement
• Perform initial inspection and raise report
• Perform in-process inspection according to procedures and customer’s specifications. Raise report whenever necessary. Measure and record the dimension of components/parts using measuring instruments and analyse the findings for discrepancy
• Perform final inspection of items including dimensional and NDT to ensure that all quality requirements has been achieved. Analyse result and decide the acceptance level of the final product
• Prepare and conduct Project Specific Quality requirements training to production Supervisors and Sub-contractors QC Personnel.
• Establishing Work Procedures and Instructions.
• Support QA/QC Manager for establishing WPS, PQR and WQT Qualifications.
• Act as Project Lead QA/QC and control the entire project Quality Assurance and Control activities during construction phase.
• Oversees the Inspector’s performance on the project towards monitoring and control of workmanship towards quality.
• Updating of Inspection status and records on daily basis.
• Attend weekly client progress review, Internal and Sub-Contractors meeting to discuss Quality issues.
• Liaise with client in relation to Quality on Project Specific.
• Schedule and conduct Project Specific Quality Audit as per agreed Plan.

Requirements:

• Degree in Engineering or Diploma in Mechanical/ Marine Engineering or equivalent
• Experience in handling project Audit and liaise with internal & external auditor
• Knowledge in structural fabrication, piping isometric drawing and materials
• Experience in piping line walk, reinstatement inspections by clear understanding of isometric drawings

Email to: [email protected] or call me at: 6398 5689 for more information.

Like us on Facebook or Instagram (For Career tips and Job vacancies): www.facebook.com/search.personnel / https://www.instagram.com/search.personnel

Join us on Linkedin: www.linkedin.com/company/search-personnel-pte-ltd

***We do not charge our candidates any referral fee nor bind them with any contract.***

Jane Chua

Associate Consulting Director (APAC)

License no: 13C6684

EA Personnel: R2197224

Thank you for your interest in this position. Our shortlisting period is 3 working days. Only shortlisted candidates will be contacted for further consideration.

If you do not receive communication from us within this timeframe, it's likely that your application has not been shortlisted by our client. In such cases, we recommend that you continue your job search to maximize your opportunities. We wish you all the best and should we have any suitable roles that match your experiences/ qualifications/ preferences, we will reach out to you.

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 Description

• To coordinates the process of product registration and market access approval in the designated countries including providing all required documents and certificates within the specified timeframe proactively to complete product registration.
• To provide advice to internal and external teams in interpreting relevant guidance documents and standards.
• To contact local authority and organization for both regulatory problems solving and obtain updated information on current and developing regulations.
• To review and approve documents to support Post Market Change notification (including labelling changes) to comply with international regulations and standards.
• To remain up to date on regulations and communicate any key changes to stakeholders in the broader organization.
• To provide training when necessary and assist with the development of the respective countries’ Regulatory Affairs infrastructure to facilitate greater speed to market.
• To take charge of QA (complaint reporting etc) for all subsidiaries.

Qualification

• Degree/ Diploma in Biomedical engineering or science or QA/RA related field
• Minimum progressive 3 years of QA/RA working experience in medical device manufacturing industry

Interested candidate, please email to [email protected]

Leon Leong De Cong

R1551708

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)

EA License: 99C4599