Total 17 qa manager job vacancies in Quality Assurance / Control category in SG-Tampines Agency Building

• Position : Quality Manager – Up to $8,000 – Changi South
• Location : Changi South
• Working hours : 5 Days Work Week – Monday to Friday: 7.30AM to 4.30PM
• Salary (commensurate with experience) : Up to $8,000 Basic + Transport Allowance + AWS + Performance Bonus + 12 Days Annual Leave + Medical & Dental Benefits
• Duration : Perm
• Industry : Industrial Gas

Responsibilities:

• Lead the Quality Department to implement effective quality assurance and control processes to ensure that the product delivered meet customers’ requirement and achieves company quality
• objectives.
• Ensure compliance to customers’ requirements throughout the organization.
• Collaborate with the Management Team and Stakeholders to define and implement the Company’s Quality Strategy.
• Manage and continuously improve company's Quality Systems in compliance with Company’s policies and standards and to industry standards such as AS9100 and NADCAP.
• Review, prepare, administer and implement Quality Assurance Plans, Inspection Test Plans and other operational procedures in accordance with the technical specifications, customer's needs
• and requirements, and good manufacturing / engineering practices.
• Define, monitor and report Company’s key performance indicators such as On-Time Delivery, First Pass Yield, Cost of Poor Quality and use these metrics for continuous improvement of Quality.
• Work closely with all departments to meet goal of 100% On-Time Delivery, Zero Defects on all customers’ orders.
• Lead internal team to resolve Quality escalation from customers through systematic root cause analysis frameworks for efficient, effective and timely corrective actions.
• Drive continuous improvement programs such as annual Quality planning, Lean Six Sigma improvement projects, Quality audits, etcetera to achieve Operational Excellence.
• Implement risk assessment systems for all critical control points in the whole quality process flow.
• Implement and maintain a system of auditing the facility and periodic calibration of test, measuring equipment and tools.
• Liaise with vendors on purchase and calibration of production equipment, gauges and Quality consumables.
• Develop and continuously build staff competencies, skills and knowledge through competency gap analysis and team members’ career progression and development plan.
• Identify and integrate relevant QA software into existing quality process flow to increase work efficiency and productivity.
• Support sales team when required by working together to liaise with external customers and stakeholders to deliver timely corrective actions.
• Report to top management on the performance of the quality management system and initiatives towards improvement.

Requirements:

• Minimum Degree in Mechanical / Materials Engineering with minimum 5 years’ experience
• Proven experience as Lead auditee in industry regulations.

Email to: [email protected]

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Jeslyn Tan

Associate Consulting Director (APAC)

Reg no.: R21101247 | EA No: 13C6684

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.

Position Summary

The IQA Engineer is responsible for ensuring all Direct and Indirect materials suppliers for production meet the quality requirements, hazardous substance regulations such as Green compliance, RoHS, REACH-SVHC, and related industry regulations. He/she must also implement material incoming specifications, monitoring of material quality performance, and resolving material related issues.

To be successful in this role, the candidate must possess excellent analytical and technical skills with strong attention to details; basic understanding of semiconductor product and process; excellent communication and problem-solving skills; and an eye for supply quality control.

Key Responsibilities

• Generate defect catalogue as reference for Incoming buy-off acceptance criteria.
• Understand & define material incoming quality check items that are critical to process performance.
• Define Incoming quality dashboard and system set up (workflow).
• Attend customer audit / response to customer surveys.
• Follow up internal and customer audit findings and closure.
• Customer Specs Review (CSR) on material requirements & ensure alignment with internal Control Plan / work instructions.
• Review quality indicators, e.g, LRR / SCAR / MRB / SPC / MSA, and upkeep of Incoming capabilities.
• Process material composition declaration (MCD) and product compliance surveys.
• Review and support Key Customers & Process related case studies / deliverables.
• Manage NPI and ensure material registration implementation.
• Any other ad-hoc duties as assigned.

Requirements

• Degree in Engineering or equivalent with a minimum of 5 years’ experience in Materials Incoming Quality Assurance or Process Quality Assurance.
• Knowledge in ISO 9001, IATF 16949 quality management standards.
• Knowledge in product environmental regulations and compliance requirements.
• Basic knowledge on product failure analysis and reliability tests.
• Excellent communication and possess firm decision making.

Preferred Qualifications

• Knowledge in SPC, MSA, DOE, FMEA and 8D methodology.
• Knowledge in Microsoft office, SAP & MES system.
• Knowledge in measuring system equipment and other measuring tools.
• Internal audit training certification.

Position Summary

The QA Engineer (Failure Analysis) is responsible for supporting and managing activities of Failure Analysis lab. Candidates with experience in Semiconductor and electronics area are encouraged to apply for this position.

Key Responsibilities

Failure Analysis

• Support failure analysis request from internal customers and external customers for any customer returns, production/process rejects, and reliability/engineering evaluation failures, and provide the final reports.
• Advise problem-solving team or cross-functional teams on appropriate FA techniques to employ in order to establish an understanding of the failure mechanism.
• Provide machine readiness and perform buyoff for new FA tools and capacity ramp-up.
• Develop new FA capabilities/techniques to enhance detection capability or productivity or optimize recipes
• Drive improvement activities such as robustness and cycle time improvement as well as cost reduction activities.
• Conduct FA staff training on FA techniques and procedures
• Maintain FA tools and lab environment to meet the 5S and safety requirement.
• Support internal and external audit and follow up all the action items captured by auditors.
• Assist Finance and sale team to generate FA service quotations for customer FA requirements.
• Work with IT team to setup system for submissions of new FA request and report uploading.
• Other ad-hoc activities assigned by the reporting manager.

Requirement

• Degree in Material/Electrical/Electronic Engineering or equivalent.
• Minimum 3 years of FA experience in the semiconductor industry.
• Have a good understanding and Knowledge of FA techniques, including cross-section, ion-mill, SAT, SEM, EDX, and Chemical Decap.
• Knowledge of semiconductor device physics is preferred.
• Understanding of semiconductor device quality issues.
• Strong leadership and communication skills.
• Excellent interpersonal skills and team approach to problem-solving.
• Self-directed and able to meet commitments.

Position Summary

The QA Engineer (Reliability) is responsible for supporting and managing activities of Reliability lab.

Candidates with experience in Semiconductor and electronics area are encouraged to apply for this position.

Key Responsibilities

Reliability Test

• Schedule and Support Reliability Test Request raised by internal and external customers.
• Provide machine readiness and perform buyoff for new Reliability tools and capacity ramp-up.
• Establish recipes for reliability tools and procedures for various reliability test and work with vendors for proper jig/carrier designs if required.
• Conduct staff training on Reliability tools and test procedures
• Maintain Reliability tools and lab environment to meet the 5S and safety requirement.
• Support internal and external audit and follow up all the action items captured by auditors.
• Assist Finance and sale team to generate reliability service quotations for external request if any.
• Work with IT team to setup system for submissions of new Reliability Test request and report uploading.
• Other ad-hoc activities assigned by the reporting manager.

Requirement

• Degree in Material/Electrical/Electronic Engineering or equivalent
• Minimum 3 years’ Reliability Test experience in the semiconductor industry.
• Have a good understanding and Knowledge of JEDEC Reliability Test Requirement and Procedures, including MSL, HTS, TC, HAST/uHAST and PCT.
• Knowledge of semiconductor device physics is preferred
• Understanding of semiconductor device quality issues
• Strong leadership and communication skills
• Excellent interpersonal skills and team approach to problem-solving
• Self-directed and able to meet commitments

Key Responsibilities:

The main responsibilities are:

• Pasir Ris Quality Transformation Project: Develop and propose target operations model for Plant Quality Singapore
• Align with QP Bernin future operations model
• Achieve local and global stakeholders alignment and buy in
• Define deployment plan and execute (including management system and reporting)
• Update respective procedures and documentation
• Assess Quality resources: Competencies, HC, performance and propose way forward to fit to the proposed target operations model
• Define training, competency management plan and execute within agreed budget boundaries
• Drive Quality improvement project

Requirements:

• Demonstrating excellent communication and the ability to communicate well with peers and various stakeholders locally and on a remote basis
• Keeping up with a fast paced international company, being resourceful and independant
• You are open-minded and cross cultural agile
• Strong problem-solving skill, independent team player and good interpersonal skills
• Initiative, responsible, and positive attitude
• Meticulous and able to work in a fast-paced environment

• Working Days: 5 days
• Working Hours: Mon to Fri : 8.30am - 5.30pm
• Working Location: East area

Responsibilities

• To lead a team of Engineers to carry out all the Test related activities for Server & Rack products for the production
• To support & implement PXE Server configuration for the products
• Perform & maintain the Server & Rack run-in test process
• Perform & maintain the burn-in & power test process
• To liaise with the customer & HQ / factory on the test program implementation and maintenance
• To test and analyze all failures in the production products and work back with customer & HQ / factory for improvement
• Participate in the Kaizen activities
• To update the test program master list & tracking
• To prepare and update Working Instruction
• To provide training over W/I to production
• To support the NPI Process
• To support production on the mass run
• Participate in ISO activities (implementation & maintenance)

Requirements:

• Minimum 1-2 years of relevant working experience in manufacturing industry/EMS.
• SAP & Linux knowledge
• Good understanding of test methods and concepts
• Knowledge of programming and debugging skills

For consideration, kindly submit your CV by clicking “APPLY Now”.

**Only shortlisted candidate would be notified**

EA Reg. No: R1988238 | Erlynn Tay Kim Geok

Position Summary

Quality Assurance Supervisor is responsible to plan and coordinate inspection task ensuring delivery of materials/products.

Candidates with experience in semiconductor manufacturing environment are encouraged to apply for this position.

Key Responsibilities:

• Plan, lead and supervise team of QA inspectors overseeing daily QA operation activities
• Provide all support related to inspection results, daily output, and other related documentations
• Ensure inspection of raw materials, components, assemblies or manufactured parts according to requirements
• Assist Quality Engineer to deploy instructions and train new hires
• On-time reporting of non-conformance
• Participate in trouble-shooting activities if any
• Any other duties and responsibilities assigned by the superior

Requirements:

• Diploma in Engineering or any similar discipline
• At least 5 years of relevant experience in semiconductor manufacturing company
• Able to read drawings, illustrations & specifications
• Able to communicate in English and other languages
• Able to perform inspection or measurement under microscope & various metrology tools to support the inspection task
• Familiar with use of instruments like micro-meter, vernier, profile projector and other measuring and test equipment
• Proficiency in MS windows and email communications
• Able to operate the CMM (coordinate measuring machines) will be advantages

Position Summary

QA Engineer/Senior Engineer (Process Quality Control) is responsible to develop & deploy inspection procedures to ensure conformance of material to be released.

Candidates with experience in semiconductor manufacturing environment are encouraged to apply for this position.

Key Responsibilities:

• Develop, plan & coordinate incoming/outgoing process and procedure
• Ensure conformance according to ISO / IATF standards
• Establish, implement & maintain processes & tools for inspection
• Manage inspectors for execution of daily operational inspection aligned to Production Plan
• Setup reporting procedure & ensure systematic recording of quality issues and defects
• Work with relevant departments to uphold product quality, manage costs and ensure customer satisfaction
• Conduct analysis of quality data to identify potential systemic issues & initiate improvements
• Core member in new product / process introduction to ensure safe launch
• Other ad-hoc activities assigned by the reporting manager

Requirements:

• At least 5 years of relevant experience in semiconduction production & inspection processes
• Well-versed with inspection plans, interpret drawings & deployment of analysis tools such as OGP (optical gaging) and even design customized jigs to aid inspection process.
• Working knowledge of MSA, GR&R, FMEA, Control Plan, SPC & 8D, JMP or Minitab, SAP, Tableau
• Bachelor’s Degree in Engineering or equivalent
• Possesses the analytical ability to structure processes and procedures, identify trends and patterns, as well as resourcefulness to propose solutions
• Demonstrate commitment to high levels of quality and customer satisfaction

AVN-Digital is an expert in providing technology enabled business solutions and services. Since inception, AVN-Digital has helped clients Cyber-security, Data Analytics and Robotic Process Automation to improve their operations and profitability, focus on core competencies and achieve business results such as increased agility, innovation and profitable growth. Our in-depth technical knowledge coupled with industry experience and our unique methodologies enable us to successfully deliver and meet our customer’s expectations.

• Proven experience as a Test Manager managing testing lifecycle of 2-3 projects right from planning till project go-live

• Complete understanding of test management activities involving requirement analysis, test design, SIT, UAT, defect management, warranty support

• Excellent skills in managing the testing project timelines and an ability to understand the, overall project deliverables and its possible impact on testing

• Ability to anticipate risks/issues in the testing project and plan the mitigations accordingly

• Ability to craft the Test Strategy and Test Planning at the beginning of the project

• Hands on experience of the test deliverables reporting on daily and weekly basis during the test execution

• Knowledge of defect management through JIRA and test management through Zphyr preferred

• Awareness of the test management metrics and estimation techniques

• Identify, assign and monitor the activities of test specialists in support of the multiple deliverables under their area of responsibility

• Responsible for defect reporting and tracking to project teams, including collaboration on defect resolutions and/or performance deficiencies with developers/partners and identification of retest requirements

• Responsible for metrics gathering and status reporting for project assignment.

Requirements:

• Hands on experience of SQL Scripting/queries and script execution

• Knowledge of the batch runs and test executions

• Preferred to have knowledge of automation using TOSCA, but not a must

• Good understanding of Data ware house and ETL process, Good understanding in SQL / PL SQL and Data base like oracle , Hive

• Participate and drive test automation improvements with tool like TOSCA, Query Surge etc.

Stakeholder Management and Team Management

• Proven ability to manage a team of 5-10 testers in the project.

• Strong domain knowledge of Transaction monitoring apps like ACTMIZE and MANTAS and AML-KYC apps like DETICA(Net Reveal).

• Strong Understanding Actimize framework and its components work together for anti-money laundering and fraud detection (e.g., Enterprise Risk Case Manager (ECRM) , RCM (Risk Case Manager), Suspicious Activity Monitoring (SAM), Customer Due Diligence (CDD) , Watch List Filtering (WLF))

• Good understanding of case management , alert generation , Actimize tool and its workflow

WHAT’S ON OFFER

You will be remunerated with an excellent base salary and entitled to attractive company benefits. Additionally, you will get the opportunity to enjoy a fun and collaborative work environment, alongside a strong career progression.

Privacy Statement: Data collected will be used for recruitment purposes only. Personal data provided will be used strictly in accordance with the relevant data protection law and AVN' privacy policy.

[What you will be working on]

In this role, you will help to review and implement policies with a focus on the

Environmental Control Officer for Specified Construction Sites [ECO(SCS)] scheme in Singapore.

• Work with the team on the formulation and review of operational policies and procedures to support NEA’s strategic objectives
• Conduct research and analysis to identify best practices and regulatory requirements for policy development
• Evaluate existing policies and recommend updates or revisions to ensure relevance and effectiveness
• Collaborate with cross-functional teams to gather inputs and feedback on proposed policies
• Review key pieces of legislation in consultation with legal department and undertake the required Act amendments
• Work with stakeholders to identify training gaps, develop competency framework, review Code of Practice and enhance training curriculum for relevant industries
• Engage stakeholders and industry to communicate policy changes, updates and/or share best practices via newsletters, organisation of webinar/seminar or other means
• Handle complex queries, feedback and appeal cases
• Coordinate meetings and assist in secretariat duties

[What we are looking for]

• Prior experience in policy formulation, learning & development, stakeholder engagement and event organisation will be an advantage
• Strong analytical and sense-making skills
• Excellent communication, writing and presentation skills to engage and influence stakeholders across different levels
• A good team player who enjoys interacting and working with others
• Self-driven, able to work independently and multi-task
• Proficient in Microsoft Office applications

As part of the shortlisting process for this role, you may be required to complete a medical declaration and/or undergo further assessment.

Applicants will be updated on the status of their applications within 4 weeks of the closing date of this job posting.

[What you will be working on]

In this role, you will help to review and implement policies with a focus on the regulation of vector pesticides and repellents in Singapore:-

• Work with the team on the formulation and review of operational policies and procedures to support NEA’s strategic objectives
• Conduct research and analysis to identify best practices and regulatory requirements for policy development
• Evaluate existing policies and recommend updates or revisions to ensure relevance and effectiveness
• Collaborate with cross-functional teams to gather inputs and feedback on proposed policies and ensure alignment with stakeholder needs
• Review key pieces of legislation in consultation with legal department and undertake the required Act amendments
• Engage stakeholders and industry to communicate policy changes, updates and provide guidance on policy implementation
• Handle complex queries, feedback and appeal cases
• Coordinate meetings and assist in secretariat duties

[What we are looking for]

• Prior relevant working experience in policy formulation and stakeholder engagement will be an advantage
• Strong analytical and sense-making skills
• Excellent communication and writing skills to engage stakeholders across different levels
• A good team player who enjoys interacting and working with others
• Self-driven, able to work independently and multi-task
• Proficient in Microsoft Office applications

As part of the shortlisting process for this role, you may be required to complete a medical declaration and/or undergo further assessment.

Applicants will be updated on the status of their applications within 4 weeks of the closing date of this job posting.

1. Leadership and Management: Quality Manager requires strong leadership committed to quality improvement. Leaders set the vision, goals, and strategies for TQE implementation, allocate resources, and provide support and guidance to employees.
2. Quality Planning: This involves setting quality objectives, identifying customer requirements, establishing processes to meet those requirements, and developing plans to achieve continuous improvement.
3. Training and Education: Quality Manager emphasizes the importance of training and educating employees at all levels of the organization to ensure they understand quality concepts, tools, and techniques, and can contribute effectively to improvement efforts.
4. Quality Control: Monitoring and measuring processes and outputs to ensure they meet quality standards. This may involve statistical process control, inspections, audits, and other quality control techniques.
5. Quality Improvement: Identifying opportunities for improvement, analyzing root causes of problems, implementing corrective and preventive actions, and continuously striving to enhance processes and products/services.
6. Customer Focus: Understanding customer needs and expectations, gathering feedback, and using it to improve products/services and enhance customer satisfaction.
7. Supplier Management: Working closely with suppliers to ensure they meet quality standards and deliver high-quality inputs, materials, and components.
8. Employee Involvement and Empowerment: Encouraging and empowering employees to participate in quality improvement efforts, share their ideas and suggestions, and take ownership of quality-related activities.
9. Measurement and Analysis: Collecting and analyzing data to track performance, identify trends, measure progress toward quality objectives, and make data-driven decisions.
10. Continuous Improvement: Establishing a culture of continuous improvement where all employees are encouraged to seek opportunities for improvement, experiment with new ideas, and learn from successes and failures.
11. Communication and Collaboration: Facilitating open communication and collaboration across departments and levels of the organization to ensure alignment of quality goals and efforts.
12. Documentation and Documentation Control: Maintaining accurate records of quality-related activities, processes, and outcomes, and ensuring proper documentation control to prevent errors and ensure compliance with quality standards and regulations such as ISO 9001-2015.

The essential responsibilities include:

• Manage, motivate, coach, and develop the Assembly staff.
• Ensure overall adherence to safety practices.
• Review the quality of products including all incoming shipments.
• Performance manage team members, giving direction and feedback to aid good performance
• Check and verify customers' complaints
• Handle customers' product warranty & repair issues via phone calls and emails.
• Fixing and repairing minor defects of products.
• Prepare documents for customer service items to return to retail stores.
• Perform any other tasks as and when assigned

Formal Education & Certification

• Secondary Education or relevant experience

Knowledge & Experience

• Minimum 5 years of relevant experience managing a team in QC setting
  Experience in supervising different shifts
• Proven ability to effectively coach & monitor QC assistants to lead and achieve desired performance goals & objectives
• Good understanding of budgeting and resource allocation
• Experienced in and a desire to lead change and work with others to implement new practices, roles, and structures

Personal Attributes

• Ability to strategically plan for the future, combined with the ability to deliver on details
• A team leader and analytical thinker with strong administrative, decision-making, time management and organizational skills
• Good interpersonal skills – ability to work and interact with all levels of management and stakeholders
• Motivational skills and an ability to supervise and lead a team
• Positive attitude
• Strong problem-solving and conflict-resolution skills
• Ability to work effectively under pressure
• Good active listening skills
• High level of initiative and integrity

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

The QA Specialist will support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, GxP contract manufacturing facility in one of 6 areas: Quality Systems, QA Engineering, External QA, QA Excellence (Transformation and Technical Compliance), Quality Operations or Audit Management.

Key responsibilities:

• Support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, GxP contract manufacturing facility.

• Display a good level of problem-solving ability by analyzing and interpreting data and puts forward new ideas based on scientific knowledge or field experience.

• Detect non-compliance with cGMP and GDP requirements and provide guidance on GDP corrections.

• Take on role of QA Specialist in Quality Operations.

• In depth awareness of entire process, identifying operational factors which influence the process.

• Review and approve change controls.

• Review and approve Master Batch Records (MBR), SOPs, protocols, reports or records.

• Support changeover activities.

• Support Annual Product Quality Review activities.

• Can trouble-shoot and able to weigh up all information and consideration in order to choose the optimum path to be taken.

• Demonstrate ability to lead a small project and manage the deliverables effectively.

• Develop good working relationships with internal & external customers.

• Able to participate actively or lead in investigations, change controls, CAPA plans and closure of discrepancy reports.

• Develop skills as an internal GxP auditor, as required.

• Provide support in regulatory inspections and customer audits as required.

• Plan for future activities and coordinate with other departments to complete this.

• Develop skills to be Qualified Trainer in area of expertise.

• Any other tasks as and when assigned by supervisor.

Key requirements:

• Bachelor's degree with exposure in the Biopharmaceutical industry.

• Relevant experience from the Biopharma or any related environment.

• Hands-on experience coordinating & interacting with internal departments on manufacturing activities.

• Knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility.

• Meticulous and Systematic.

• Team player, with strong focus on safety, quality and timelines.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

We provide company transport, both ways, at multiple pick up points.

Job Descriptions

- Perform hands on pest control work on customers' sites

• Attend to Clients' complaints on pest issues and understand the potential causes of pests' activities

• Conduct on-site routine reviews to Client's premises to check on the quality of the technical team and ensure Company's SOP and Protocol are followed thru' by technicians.

• Prepare ad-hoc / monthly formal reports to clients with recommendations for remedial actions for enhanced protection of their premises.

• Attend meetings with technical team as well as NEA inspectors on site.

• Do presentations during meetings in front of customers/NEA officers to review pest issues

• Implement on work plan, Risk Assessment, Safe Work Procedures, hygiene standards to ensure compliance with Workplace Safety & Health Environment.

• Maintain mandatory records and other documentations for Bizsafe Level 3 Certification.

• Strong knowledge on General pests & safety regulations will be an added advantage.

• Proficient in MS Office.

• Ability to lead

• Good command of English

• Minimum 4 years experience in the relevant field.

• NEA Pest Management Licence preferred

• Must have Class 3 driving licence

• Able to start work immediately or short notice.

• Must be prepared to be on standby duty 24/7 even on weekends or public holidays

The Senior QA Specialist will lead and support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for multi-product s and also provides QA support for Audit Management.

Responsibilities:

• Monitor day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a large scale, multi-product, and GMP biotech contract manufacturing facility.

• Highly motivated individual and have superior skills in all areas relevant to the job.

• Member of cross-functional site team(s) on projects/ issues.

• Lead in complex deviation investigations, change controls, CAPA proposals and closure of discrepancy reports.

• Superior ability to troubleshoot.

• A competent Reviewer and Approver of SOPs, protocols, reports or records.

• Able to coordinate between departments for multiple parallel activities.

• Understanding of advanced topics pertaining to cGMP.

• Participate in Customer / Agency Audits and Inspections as required.

• Identify process pathways and work to develop improvements in strategy.

• Help/Transfer and quickly assimilate to leadership role in other process areas.

• Assume Supervisory responsibility in absence of supervisor

• Understands and articulates company business strategy. Maintains a broad view of the

  business, recognize changes and trends in the appropriate area in which the individual

  operates.

• Any other tasks as and when assigned by supervisor.

Requirements:

• Engineering/Science Degree or higher from recognized institution with 5 to 10 years’ experience in Validation / Quality unit in the Biopharmaceutical industry

• Familiar with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7).

• Good knowledge and experience of the practical and theoretical requirement of quality management system in GMP facility 

• Good interpersonal skills

• Effective Communicator (oral and written)

• Exhibit good quality decision making traits

• Meticulous, Systematic and Analytical Mind

• Team player who can operate independently, with strong focus on safety, quality and timelines.