QA Specialist

7 months ago

Singapur, Singapore Pfizer Full time

Job Description

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 team. You will evaluate and review Pfizer’s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures.

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

POSITION SUMMARY

Drive quality culture and promote GMP compliance behaviors to the site. Ensure site compliance to Pfizer Quality Standards (PQS) and ICH guidelines. Provide QA 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 systems. Understand regulatory expectations and support site inspection readiness. Work with supply chain and drug product sites to ensure timely delivery of quality products. Work with GCMC to file products and address regulatory queries in an accurate and timely manner. Require working on rotating shift.

How You Will Achieve It

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. Disposition the intermediates and active pharmaceutical ingredients (API). Review and approve cleaning records and procedures and ensure compliance with the Pfizer Quality Standards (PQS) and guidelines. Support production startup activities, changeover activities, equipment releases, module clearances etc Tank farm monitoring and QA oversight of the solvent recovery processes. Review and approve GMP documentation and ensure their compliance to Pfizer Quality Standards (PQS). Ensure adherence to quality procedures, regulatory requirements and cGMPs. Perform Quality Impact assessment for Change control. Improve quality assurance systems, as necessary. Write deviations according to the site procedures. Ensure issues are escalated according to the Pfizer Quality Standards (PQS). 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. Support 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 QA oversight of the pest control program

Qualifications

Must-Have

Bachelor's Degree/Diploma in Science/Chemical Engineering or equivalent Experience in pharmaceutical industry Experience in Quality administered systems Sound knowledge of current Good Manufacturing Practices {part of GxP} Ability to work in a team environment within own team and interdepartmental teams Effective written and oral communication skills

Nice-to-Have

Experience at a manufacturing site Experience of writing reports Experience in production batch record review, Enterprise Resource Planning system, campaign changeover, startup support and change control management
Work Location Assignment: On PremisePfizer 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

  • QA Engineer

    7 months ago

    Singapur, Singapore Helius Full time

    Your Key Responsibilities: Analyze and test software to ensure that products meet design specifications and are within total quality management limits and standards Collaborate with cross-functional teams to develop comprehensive test plans based on requirements. Execute test cases, identify defects, and ensure timely resolution. Isolate, replicate,...

  • Senior Specialist QA

    5 months ago

    Singapur, 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,...

  • Specialist 3, QA

    5 months ago

    Singapur, 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,...

  • Testing / QA / Processes #EOI

    4 months ago

    Singapur, Singapore Singtel Full time

    At Singtel, our mission is to Empower Every Generation. We are dedicated to fostering an equitable and forward-thinking work environment where our employees experience a strong sense of Belonging, to make meaningful Impact and Grow both personally and professionally. By joining Singtel, you will be part of a caring, inclusive and diverse workforce that...

  • Senior Sales Specialist APAC

    6 months ago

    Singapur, Singapore Zendesk Full time

    Job DescriptionAs a Sales Specialist for Zendesk QA you will collaborate closely with a team of Zendesk Account Executives and Solution Engineers to ensure the adoption of Quality Assurance to customer support and customer experience teams. Affinity with fast evolving technology, such as AI, is crucial while a proven track record of meeting sales targets...

  • Quality Assurance

    7 months ago

    Singapur, Singapore Delta Capita Full time

    DescriptionRole SummaryThis is a great opportunity to join our dynamic business working with some of the world’s leading financial institutions. This specific role is within the Client Lifecycle Management (CLM) technology transformation area (Client Onboarding, Maintenance, Offboarding). This role requires hands on experience and knowledge with technical...

  • Quality Specialist

    7 months ago

    Singapur, Singapore Baxter Full time

    This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...

  • Growth Marketing Specialist

    5 months ago

    Singapur, Singapore Maker Lab Full time

    Grounded in a talent-centric mindset, Maker Lab is a marketing agency designed to build decentralised technology-led agency teams, rooted in collaboration with clients from the ground up. Maker Lab’s cross-functional teams of multidisciplinary specialists are embedded into client teams across digital marketing competencies — from measurement & analytics...

  • Performance Specialist

    7 months ago

    Singapur, Singapore dentsu Full time

    The purpose of this role is work closely with the Digital Performance teams to implement and execute Performance Marketing campaigns, in line with the agreed strategy, to maintain, develop and exceed client performance targets. Job Title: Performance Specialist Job Description: About our Media Services We provide clients with a complete range of...

  • Sr. Regulatory Affairs and Quality Assurance Specialist, Diagnostics SEA

    2 months ago

    Singapur, Singapore Cepheid Full time

    Wondering what’s within the Diagnostics Platform and Danaher? Take a closer look. The family of Diagnostics companies at Danaher work with conviction that every moment matters and realize that behind every test is a patient, waiting for an answer that could change their life. Our 23,000 team members, across 6 operating companies globally, proudly...

  • Associate/Consultant (Anatomical Pathologist / Histopathology)

    7 months ago

    Singapur, Singapore Khoo Teck Puat Hospital (KTPH) Full time

    An Anatomical Pathologist / Histopathologist position is available at the Khoo Teck Puat Hospital (KTPH) in Singapore. The Associate Consultant / Consultant / Senior Consultant position is based in the Department of Laboratory Medicine (DLM), which provides a range of comprehensive laboratory services to KTPH, the adjoining Yishun Community Hospital...

  • Market Implementation Specialist/Manager, Southeast Asia

    6 months ago

    Singapur, Singapore Applied Medical Full time

    Responsibilities Strategic and Tactical Implementation of Products Work closely with local team and distributors in defining clinical sales and branding strategies. Attend procedures to ascertain in-field product performance and market development opportunities. Understand the selling process in the different Southeast Asian Markets to identify any...

  • Technical Consultant – AVP/Vice President

    7 months ago

    Singapur, Singapore Delta Capita Full time

    DescriptionRole SummaryThis is a great opportunity to join our dynamic business working with some of the world’s leading financial institutions. This specific role is within the Client Lifecycle Management (CLM) technology transformation area (Client Onboarding, Maintenance, Offboarding). This role requires hands on experience and knowledge with technical...

  • Knowledge Management Specialist

    3 months ago

    Singapur, Singapore Wise Full time

    Job Description Role & Job Purpose The Knowledge Management team’s mission is to help Wise achieve Mission 0 through enabling its operational teams to scale and provide excellent service to our customers by building and maintaining a centralised, easily accessible and high-quality knowledge base. As a Knowledge Management Specialist, you will...

  • Strategic Programs

    2 months ago

    Singapur, Singapore TikTok Full time

    Team Introduction The Monetization Product Operations (MPO) is responsible for Customer Support and Tools & Workflows within Product Strategy & Operations team. Its mission is to provide Best in class advertising experience by ensuring excellence in customer service and streamlining processes & tools to ensure smooth operations.The team collaborates with...

  • Order Management Specialist

    5 months ago

    Singapur, Singapore Pottery Barn Full time

    JOB SUMMARY: Founded in 1956, Williams-Sonoma, Inc. is the premier specialty retailer of home furnishings in the United States and Canada. Our brands are among the best known and respected in the industry, including Williams-Sonoma, Pottery Barn, Pottery Barn Kids, Pottery Barn Teen, and West Elm. We successfully market our brands through three major...

  • Senior QC Specialist

    4 months ago

    Singapur, Singapore GenScript Full time

    About GenScript GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a...

  • Senior QC Specialist

    4 months ago

    Singapur, Singapore GenScript Full time

    About GenScript GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a...

  • Warehouse Specialist

    3 months ago

    Singapur, Singapore Abbott Full time

    Primary Function: Responsible for executing warehouse policies and procedures and implementation of safety, quality and operational excellence programs in the warehouse to drive safe, compliant and efficient operations. Responsible for training of all internal warehouse personnel and outsourced service providers. Responsible for material receiving and...

  • Key Account Executive

    2 months ago

    Singapur, Singapore Abbott Full time

    Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. We are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality...