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QA Specialist (Compliance) (PCP) 15 months training programme
Pfizer, S.A. de C.V
Singapore
On-site
SGD 40,000 - 60,000
Full time
Job summary
A leading pharmaceutical company in Singapore seeks a QA Specialist for a 15-month training program. The incumbent will ensure compliance with quality standards and collaborate with teams to improve quality systems. Candidates must have a degree in a science-related discipline and at least one year of pharmaceutical experience. This role offers competitive benefits and opportunities for career advancement.
Benefits
Qualifications
- Minimum 1 year experience within the pharmaceutical industry.
- Ability to perform audits and resolve compliance issues.
- Experience with GMP and regulatory inspections is a plus.
Responsibilities
- Drive quality culture and promote GMP compliant behaviors at the site.
- Ensure site compliance to Pfizer Quality Standards (PQS) and ICH guidelines.
- Collaborate with cross functional teams to improve quality systems.
Skills
Education
Job description
We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.
To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products.
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.
Transforming Delivery of high quality products
Pfizer, We are one
PGS - Manufacture the Future
Job Description
Career Progression Program (CCP) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals
We are pleased to announce the Career Progression Program (CCP) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals, a distinguished talent development initiative aimed at cultivating the next generation of skilled professionals for Singapore's biopharmaceutical manufacturing industry.
Program Overview:
- Duration:15 months
- Attachment:Local attachment to Pfizer Inc.
- Singapore Citizens or Singapore Permanent Residents
- Have no prior working experience in the biopharmaceutical sector
- Mid-Career Candidate: Graduated for at least 2 years prior to point of application
This comprehensive program is meticulously designed to provide participants with the requisite skills and experience to meet the anticipated hiring demand within the biopharmaceutical manufacturing sector.
We invite eligible candidates to apply for this exceptional opportunity to advance their careers with one of the industry's leading organizations.
POSITION SUMMARY
The incumbent is a member of the Quality Assurance team. Under the supervision of the Senior Compliance Manager, the
incumbent will be responsible for the following:
- Drive quality culture and promote GMP compliant behaviours at the site.
- Ensure site compliance to Pfizer Quality Standards (PQS) and ICH guidelines.
- Provide quality oversight to vendor management to ensure production materials used meet Pfizer Quality Standards
(PQS).
- Work with GCMC to file products and address regulatory queries in an accurate and timely manner.
- Ensure site inspection readiness and responsible for management of logistics for internal and external GMP
inspections.
- Collaborate with cross functional teams to improve quality systems.
- Contribute to achieve our vision of being best in class manufacturing site, producing highest quality products in the
safest way.
POSITION RESPONSIBILITIES
- Review and approve GMP documentation to ensure their compliance with PQS.
- Qualify and manage vendors according to PQS and maintain accurate records of vendor status. Review and analyze the quality related issues from vendors and recommend improvement actions to mitigate compliance risks. Ensure vendors and materials are qualified as required to support production schedule.
- Conduct internal audits to ensure internal controls are effective. Conduct external audits to ensure adequate oversight to vendors and collaborate with vendor to reduce material quality issues.
- Manage logistics for internal and external GMP inspections, including site communications and training.
- 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 and adhere to site procedures and PQS.
- Facilitate and prepare regulatory submissions and attend to regulatory queries in a timely manner.
- Ensure gap analysis of site procedures against PQS is performed by relevant SMEs in a timely manner meeting requirements for rollout of new / updated PQS / Policy Memos.
- Participate in gap analysis of site procedures against PQS and propose required actions to address identified gaps and mitigate risks.
- Maintain current quality tracking systems and quality metrics to proactively identify trends and atypical observations.
- Support preparation and/or coordination of site monthly and adhoc Site Quality Review Team (SQRT) meetings.
- Uphold Pfizer's code of conduct and values.
- Play an active and impactful role in Tier processes by updating performance against metrics, highlighting & resolving issues, with appropriate escalations.
- Collaborate with cross-functional teams to drive flawless execution.
- Actively participate in Safety initiatives, and perform investigation related to EHS (as needed).
JOB RELATED REQUIREMENTS
- Demonstrate ability to act independently to resolve issues, with appropriate escalations (as required).
- Strong verbal, written communication and presentation skills.
- Demonstrated ability to perform in a team.
- Possess a can-do / pride to succeed attitude.
- Embrace the use of digital technology to scale and speed up every form of interaction and action.
ORGANIZATIONAL RELATIONSHIPS
The incumbent will interact with all site departments for GMP related operations and activities e.g. Manufacturing Operations Process Teams, Quality Control, Supply Chain, Engineering, New Production Introduction and Technical Services teams as well as above site teams (e.g. PQS SMEs). For vendor management, inspection / regulatory related issues, this position will interact with quality or regulatory representatives from drug product sites, corporate groups or Global Chemistry Manufacturing & Compliance (GCMC) teams and material / GMP service vendors.
EDUCATION
Degree in Chemistry, Microbiology, Engineering or other Science related discipline
EXPERIENCE
- Minimum 1 year experience within the pharmaceutical industry.
- Strong written and oral 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 ControlJob Description
Career Progression Program (CCP) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals
We are pleased to announce the Career Progression Program (CCP) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals, a distinguished talent development initiative aimed at cultivating the next generation of skilled professionals for Singapore's biopharmaceutical manufacturing industry.
Program Overview:
- Program Type:Mid-Career Change
- Duration:15 months
- Attachment:Local attachment to Pfizer Inc.
- Eligibility:
- Singapore Citizens or Singapore Permanent Residents
- Have no prior working experience in the biopharmaceutical sector
- Mid-Career Candidate: Graduated for at least 2 years prior to point of application
- Training Allowances:CPF exempted
This comprehensive program is meticulously designed to provide participants with the requisite skills and experience to meet the anticipated hiring demand within the biopharmaceutical manufacturing sector.
We invite eligible candidates to apply for this exceptional opportunity to advance their careers with one of the industry's leading organizations.
Use Your Power for Purpose
POSITION SUMMARY
The incumbent is a member of the Quality Assurance team. Under the supervision of the Senior Compliance Manager, the
incumbent will be responsible for the following:
- Drive quality culture and promote GMP compliant behaviours at the site.
- Ensure site compliance to Pfizer Quality Standards (PQS) and ICH guidelines.
- Provide quality oversight to vendor management to ensure production materials used meet Pfizer Quality Standards
(PQS).
- Work with GCMC to file products and address regulatory queries in an accurate and timely manner.
- Ensure site inspection readiness and responsible for management of logistics for internal and external GMP
inspections.
- Collaborate with cross functional teams to improve quality systems.
- Contribute to achieve our vision of being best in class manufacturing site, producing highest quality products in the
safest way.
POSITION RESPONSIBILITIES
- Review and approve GMP documentation to ensure their compliance with PQS.
- Qualify and manage vendors according to PQS and maintain accurate records of vendor status. Review and analyze the quality related issues from vendors and recommend improvement actions to mitigate compliance risks. Ensure vendors and materials are qualified as required to support production schedule.
- Conduct internal audits to ensure internal controls are effective. Conduct external audits to ensure adequate oversight to vendors and collaborate with vendor to reduce material quality issues.
- Manage logistics for internal and external GMP inspections, including site communications and training.
- 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 and adhere to site procedures and PQS.
- Facilitate and prepare regulatory submissions and attend to regulatory queries in a timely manner.
- Ensure gap analysis of site procedures against PQS is performed by relevant SMEs in a timely manner meeting requirements for rollout of new / updated PQS / Policy Memos.
- Participate in gap analysis of site procedures against PQS and propose required actions to address identified gaps and mitigate risks.
- Maintain current quality tracking systems and quality metrics to proactively identify trends and atypical observations.
- Support preparation and/or coordination of site monthly and adhoc Site Quality Review Team (SQRT) meetings.
- Uphold Pfizer's code of conduct and values.
- Play an active and impactful role in Tier processes by updating performance against metrics, highlighting & resolving issues, with appropriate escalations.
- Collaborate with cross-functional teams to drive flawless execution.
- Actively participate in Safety initiatives, and perform investigation related to EHS (as needed).
JOB RELATED REQUIREMENTS
- Demonstrate ability to act independently to resolve issues, with appropriate escalations (as required).
- Strong verbal, written communication and presentation skills.
- Demonstrated ability to perform in a team.
- Possess a can-do / pride to succeed attitude.
- Embrace the use of digital technology to scale and speed up every form of interaction and action.
ORGANIZATIONAL RELATIONSHIPS
The incumbent will interact with all site departments for GMP related operations and activities e.g. Manufacturing Operations Process Teams, Quality Control, Supply Chain, Engineering, New Production Introduction and Technical Services teams as well as above site teams (e.g. PQS SMEs). For vendor management, inspection / regulatory related issues, this position will interact with quality or regulatory representatives from drug product sites, corporate groups or Global Chemistry Manufacturing & Compliance (GCMC) teams and material / GMP service vendors.
EDUCATION
Degree in Chemistry, Microbiology, Engineering or other Science related discipline
EXPERIENCE
- Minimum 1 year experience within the pharmaceutical industry.
- Strong written and oral communication skills.
Work Location Assignment:On Premise
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 ControlResearch confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.
Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:
“Breakthroughs” - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.
“Change” - We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better.
“Patients’ lives” - We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view.
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.
To fully realize Pfizer’s purpose, we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.
Courage: Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.
Excellence: We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.
Equity: We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.
Joy: We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.
Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products.
With an unwavering commitment to ensuring the availability and accessibility of these life-saving medications, we play a pivotal role in reaching patients, healthcare professionals, and markets across the globe.
Our network of state-of-the-art manufacturing facilities, strategically located distribution centers , and streamlined logistics systems enables us to deliver Pfizer's medicines with utmost efficiency and reliability, making a tangible difference in patients' lives worldwide.
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.
Our Competitive Benefits Programs help our colleagues by:
- Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing . Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
- Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
- Providing Benefits and Time off for the Moments that Matter to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12 week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, bereavement leave, and additional country-specific programs.
- And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness centers , movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.
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