Senior QA Specialist

2 weeks ago

Tuas, Singapore Pfizer Full time

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. You will be responsible for activities involved in quality oversight for change control system, product change control oversight with Regulatory Affairs and APR program management. You will also be relied on to support non-manufacturing functions, quality strategic planning, performance metrics and quality goals and objectives. You will also quality provide related oversight for other functions.

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It
- Handle product complaints. Ensure complaints are investigated thoroughly with CAPAs effective to prevent recurrence.
- Responsible to review and approve master batch records and subsequent batch records associated with the manufacturing, packaging and labeling of intermediates and active pharmaceutical ingredients (API) to ensure batches produced are in compliance with Pfizer quality standards and regulatory registered specifications.
- Prepare Annual trend for deviations and Product Complaints
- Review and approve GMP documentation and ensure their compliance to Pfizer Quality Standards (PQS).
- Ensure adherence to quality procedures, regulatory requirements and cGMPs.
- Improve quality assurance systems, as necessary.
- Maintain current quality tracking systems and the quality metrics to proactively identify trends and atypical observations.
- Coordinate with cross-functional team to prepare Annual Product Record Reviews, discuss trends and atypical observations and recommend improvement actions.
- Conduct internal audits to ensure the internal controls are effective.
- 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
- Qualify and manage suppliers according to Pfizer Quality Standards (PQS) and maintain accurate records of supplier status. Review and analyze the quality related issues from suppliers and recommend improvement action to mitigate compliance risk to Pfizer.

**Qualifications**:
Must-Have
- Bachelor's Degree in Science/Chemical Engineering or equivalent.
- 4+ years' experience in Quality Assurance role within the pharmaceutical industry
- Strong written and verbal communication skills

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control

LI-PFE

  • Senior QA Specialist

    1 week ago

    Tuas, Singapore Pfizer Full time

    QA Specialist (QC Support): - We are looking for individual who can work independently, have good interpersonal skill and good laboratory compliance. The incumbent will have the responsibility for QA operational oversight for the site Quality Control (QC) and ensures overall quality integrity of the chemical and microbiological laboratories to support the...

  • QA Specialist

    2 weeks ago

    Tuas, Singapore Pfizer Full time

    : We are looking for individual who can work independently, have good interpersonal skill and good laboratory compliance. The incumbent will have the responsibility for QA operational oversight for the site Quality Control (QC) and ensures overall quality integrity of the chemical and microbiological laboratories to support the testing, approval and release...

  • QA Validation Specialist

    2 weeks ago

    Tuas, Singapore GSK Full time

    **Site Name**: Singapore - Tuas **Posted Date**: Oct 16 2024 **_ Purpose:_**: - To lead and manage Site validation activities (as assigned) to ensure that validations are in compliance with company procedures, regulatory requirements, and cGMP expectations. - To provide QA compliance oversight over IT and Technical Services (as...

  • QA Specialist 3, Operations

    2 days ago

    Tuas, Singapore Lonza Full time

    Singapore, Tuas SingaporeToday, 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...

  • QA Specialist Label Design

    1 week ago

    Tuas, Singapore Superform Consulting Pte Ltd Full time

    Job Title: QA Specialist Label Design **Salary**: Up to $4000 Location: Tuas Working Days: Monday - Friday Working Hours: 7.45 am to 4.55 pm **Responsibilities**: - Work with the graphics and translation to create artwork, drawings, and associated documentation for labeling. - Ensure that labeling artwork and proofs are accurate and meet all medical...

  • Senior Specialist/expert, QA Ops

    2 weeks ago

    Tuas, Singapore Novartis Full time

    **Summary**: Responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements and the Novartis Quality Manual and is conducted according to the relevant Standard Operating...

  • Specialist 3, QA

    6 days ago

    Tuas, Singapore Lonza Full time

    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,...

  • Senior Specialist Ii, QA Cell Therapy

    1 week ago

    Tuas, Singapore Lonza Full time

    Today, Lonza is one of the world’s largest healthcare manufacturing organizations operating across five 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....

  • Specialist 3, QA

    1 week ago

    Tuas, Singapore Lonza Full time

    Singapore, Tuas SingaporeToday, 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...

  • Specialist 2, QA

    2 weeks ago

    Tuas, Singapore Lonza Full time

    Singapore, Tuas SingaporeToday, 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...

  • QA Supervisor

    2 weeks ago

    Tuas, Singapore Pfizer Full time

    Why Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through...

  • Senior QA Engineer

    7 days ago

    d jurong, jurong island, tuas, sg TMO MANUFACTURING PTE. LTD. Full time

    Roles & ResponsibilitiesThe Senior QA Engineer will be responsible for developing the organisation's quality system along with the QA Manager. The Senior QA Engineer will also take part in quality investigations, impact analysis, and first-article inspection processes. He/She will oversee the technical library, ensuring the Quality Management System (QMS)...

  • Senior QA Engineer

    4 days ago

    d jurong, jurong island, tuas, sg TMO MANUFACTURING PTE. LTD. Full time

    Roles & Responsibilities The Senior QA Engineer will be responsible for developing the organisation's quality system along with the QA Manager. The Senior QA Engineer will also take part in quality investigations, impact analysis, and first-article inspection processes. He/She will oversee the technical library, ensuring the Quality Management System (QMS)...

  • QA Specialist

    2 weeks ago

    Tuas, Singapore Pfizer Full time

    ***: - Drive quality culture and promote GMP compliance behaviours to the site. - Ensure site compliance to Pfizer Quality Standards (PQS) and ICH guidelines. - Provide oversight to the site GMP operations to ensure products produced in compliance with the Pfizer Quality Standards (PQS). - Collaborate with cross functional teams to improve quality...

  • Senior QA Manager

    2 weeks ago

    Tuas, Singapore Pfizer Full time

    The incumbent will be required to develop strategic and system action plans by conducting risk assessment, identifying critical control points and preventive measures, establishing critical limits, monitoring procedures, corrective actions, and verification procedures. The incumbent will ensure that the quality systems, the products manufactured and Good...

  • Senior QA Lead

    4 days ago

    d jurong, jurong island, tuas, sg TMO MANUFACTURING PTE. LTD. Full time

    Job OverviewTMO Manufacturing Pte. Ltd. is seeking a highly skilled Senior QA Engineer to join our team. As a key member of the organization, you will play a vital role in developing and maintaining our quality system.Key ResponsibilitiesOversee daily workflow and resource allocation within the QA department.Collaborate with the QA Manager to ensure products...

  • Specialist 2/3, QA

    13 hours ago

    Tuas, Singapore Lonza Full time

    Singapore, Tuas SingaporeToday, 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...

  • Senior QA Executive

    2 weeks ago

    Tuas, Singapore GSK Full time

    **Site Name**: Singapore - Tuas **Posted Date**: Jan 8 2025 **Purpose** To assist Quality Lead (Systems) and Manager (Compliance and Systems) in the management and administration of quality systems in line with GSK standards and cGMP regulatory requirements. Quality systems include document management, training compliance, archival, etc. **Key...

  • QA Supervisor

    2 weeks ago

    Tuas, Singapore Pfizer Full time

    Why Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through...

  • Associate QA

    13 hours ago

    Tuas, Singapore Amgen Full time

    Career Category Quality **Job Description**: HOW MIGHT YOU DEFY IMAGINATION? Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human...