Quality Assurance Manager

Pfizer, S.A. de C.V; Singapore; On-site; SGD 100,000 - 150,000; Full time

Job summary

A leading pharmaceutical company in Singapore is seeking a Quality Assurance Lead to manage quality initiatives and ensure compliance with regulations. The ideal candidate boasts over 15 years in the pharmaceutical industry and has expertise in quality assurance processes. Strong leadership, problem-solving skills, and effective communication are essential for this role, which offers competitive benefits and a dynamic working environment.

Benefits

Health and disability insurance

Retirement plan contributions

Parental leave policy

Qualifications

• 15+ years' experience in the Pharmaceutical Industry or other GMP setting.
• Thorough knowledge of Current Good Manufacturing Practices.
• Demonstrated record with global regulatory and auditing groups.

Responsibilities

• Lead and guide moderately complex projects in quality assurance.
• Resolve complex problems and manage resources effectively.
• Conduct audits and provide feedback during the audit process.

Skills

Strong understanding of QA requirements

Excellent verbal and written communication skills

Ability to manage multiple projects

Experience conducting GMP system audits

Education

Bachelor's Degree in Chemistry, Biology or Other Health Science

Tools

MS Office applications

Enterprise systems such as PDM, EQMS

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

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients.

What You Will Achieve

In this role, you will:

• Lead and guide moderately complex projects, managing time and resources effectively, and apply skills and discipline knowledge to departmental work
• Make decisions to resolve complex problems, develop new options guided by policies, and operate independently in ambiguous situations
• Support the development of quality strategic initiatives, lead continuous inspection readiness, and drive effective management of quality issues and CAPAs
• Ensure reference standard testing is conducted in a manner consistent with cGMPs, Pfizer policies, site procedures and regulatory guidance.
• Review/approve various types of laboratory documentation. These documents would include (but are not limited to) laboratory investigation reports, deviation reports, change control documentation, certificate of results, laboratory instrument qualification/calibration, laboratory procedures, memorandums and quality alerts according to procedure requirements.
• Create, track and approve corrective/preventative action items to help ensure they are completed with the agreed timeframes.
• Provide QA approval of Reference Standard Materials in the Reference Standard Database.
• Perform internal audits or host external audits as needed and provide timely feedback during the audit process. Assure adequate follow-up and resolution of external or internal audit findings.
• Provide support with the training and document management systems within SLS.
• Leading and participating on limited duration teams to achieve specific objectives.
• Managing assigned tasks/projects within agreed upon timeframes.

Here Is What You Need (Minimum Requirements)

• Bachelor's Degree in Chemistry, Biology or Other Health Science
• 15+ years' experience working in the Pharmaceutical Industry or other GMP setting with an emphasis in Quality Assurance.
• Thorough knowledge and understanding of the technical and commercial aspects of a Corporate Reference Standard Program, Current Good Manufacturing Practices {part of GxP}, validation principles, and applicable regulations
• Demonstrated record of successful interaction with global regulatory and other internal and external auditing groups
• Experience in conducting GMP system audits.
• Strong understanding of QA requirements and is aware of industry trends
• Experience in preparing and negotiating Quality Agreements with contract sites
• Good understanding of the principles and application of quality risk management
• Ability to manage multiple projects simultaneously typically involving cross functional teams.
• Excellent verbal and written communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups

Bonus Points If You Have (Preferred Requirements)

• Experience in Quality Systems in pharmaceutical, medical device, or combination product industry
• Strong leadership and team management skills
• Ability to work under pressure and meet tight deadlines
• Ability to influence and negotiate with stakeholders
• Advanced computer skills in MS office applications and good knowledge of enterprise systems, such as PDM, EQMS, Documentum platforms

Non-Standard Working schedule, Tavel or Environment Requirements:

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

Use Your Power for Purpose

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients.

What You Will Achieve

In this role, you will:

• Lead and guide moderately complex projects, managing time and resources effectively, and apply skills and discipline knowledge to departmental work
• Make decisions to resolve complex problems, develop new options guided by policies, and operate independently in ambiguous situations
• Support the development of quality strategic initiatives, lead continuous inspection readiness, and drive effective management of quality issues and CAPAs
• Ensure reference standard testing is conducted in a manner consistent with cGMPs, Pfizer policies, site procedures and regulatory guidance.
• Review/approve various types of laboratory documentation. These documents would include (but are not limited to) laboratory investigation reports, deviation reports, change control documentation, certificate of results, laboratory instrument qualification/calibration, laboratory procedures, memorandums and quality alerts according to procedure requirements.
• Create, track and approve corrective/preventative action items to help ensure they are completed with the agreed timeframes.
• Provide QA approval of Reference Standard Materials in the Reference Standard Database.
• Perform internal audits or host external audits as needed and provide timely feedback during the audit process. Assure adequate follow-up and resolution of external or internal audit findings.
• Provide support with the training and document management systems within SLS.
• Leading and participating on limited duration teams to achieve specific objectives.
• Managing assigned tasks/projects within agreed upon timeframes.

Here Is What You Need (Minimum Requirements)

• Bachelor's Degree in Chemistry, Biology or Other Health Science
• 15+ years' experience working in the Pharmaceutical Industry or other GMP setting with an emphasis in Quality Assurance.
• Thorough knowledge and understanding of the technical and commercial aspects of a Corporate Reference Standard Program, Current Good Manufacturing Practices {part of GxP}, validation principles, and applicable regulations
• Demonstrated record of successful interaction with global regulatory and other internal and external auditing groups
• Experience in conducting GMP system audits.
• Strong understanding of QA requirements and is aware of industry trends
• Experience in preparing and negotiating Quality Agreements with contract sites
• Good understanding of the principles and application of quality risk management
• Ability to manage multiple projects simultaneously typically involving cross functional teams.
• Excellent verbal and written communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups

Bonus Points If You Have (Preferred Requirements)

• Experience in Quality Systems in pharmaceutical, medical device, or combination product industry
• Knowledge or exposure to data science
• Strong leadership and team management skills
• Ability to work under pressure and meet tight deadlines
• Ability to influence and negotiate with stakeholders
• Advanced computer skills in MS office applications and good knowledge of enterprise systems, such as PDM, EQMS, Documentum platforms

Non-Standard Working schedule, Tavel or Environment Requirements:

Some after hour/weekend work maybe required

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

Breakthroughs that change patients’ lives

Research 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.

Our Values

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.

Benefits at Pfizer

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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