Associate Manager-Manufacturing Compliance
- India - Vizag
Use Your Power for Purpose
Pfizer is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Your contributions will be vital and will have a direct impact on patient care, ensuring we deliver on our promise of quality and safety.
What You Will Achieve
Use Your Power for Purpose
Pfizer is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Your contributions will be vital and will have a direct impact on patient care, ensuring we deliver on our promise of quality and safety.
What You Will Achieve
You will be responsible for activities involved in developing and maintaining programs, processes and procedures that ensure compliance with established standards and agency guidelines. Your contribution in quality risk management will help us in commitments tracking, interpreting policies, manage site complaints and work directly with operating entities to provide process analyses oversight.
In this role, you will:
Responsible for implementing and maintaining the quality systems and ensuring compliance throughout end-to-end manufacturing operations
Responsible for inspection readiness activities and ensuring all the manufacturing processes are in compliant with Pfizer policies and regulatory guidelines
Prepare and maintain Quality Risk Assessments for equipment and processes.
Track implementation of mitigation plans and ensure timely closure of identified risks.
Prepare, review, and approve Master Manufacturing Records (MMRs) and Master Packing Records (MPRs) for commercial, scale-up, exhibit, intended, and process validation batches.
Ensure all documentation complies with GDP and ALCOA principles.
Initiate Change Control Forms (CCFs), coordinate with cross-functional teams for impact assessment, and manage pre-approval and closure.
Update procedures as per approved CCFs and ensure timely upload in PLS.
Monitor and track action items related to CCFs for closure within defined timelines.
Prepare responses to audit observations and propose CAPAs in consultation with SMEs, owners, and QA.
Track CAPA implementation and provide regular updates to stakeholders.
Support investigations and ensure timely closure of CAPAs and commitments.
Review and approve SOPs, job aids, and SOJTs in PDOCS as primary or secondary owner.
Prepare, review, and execute protocols and user requirement specifications.
Manage classified area access for colleagues, contingent workers, and service providers.
Review and approve alarm reports, conductivity reports, NVPC trend reports, and APQR reports.
Verify NVPC monitoring activities and perform assessments of PQS, CAS, and compendial requirements.
Establish alert and action levels for Environmental Monitoring.
Prepare, review, and approve cross-contamination strategy documents and PCER documents.
Deliver Instructor-Led Training (ILT) sessions to colleagues and service providers as required.
Participate in regulatory and RQA audits and ensure compliance with applicable standards.
Ensure document management and walkthrough compliance.
Maintain adherence to GDP and ALCOA principles in all documentation and processes.
Here Is What You Need (Minimum Requirements)
Master’s degree/bachelor's degree in pharmacy with 8+ years of experience preferably in Manufacturing or Quality Assurance department in a sterile Injectable manufacturing site.
Must have extensive exposure to manufacturing operations, IPQA activities, QMS activities and inspection readiness
Strong understanding of USFDA regulatory requirements and compliance standards.
Excellent attention to detail and organizational skills.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Effective written and verbal communication skills.
Skills with Lean six sigma tools
Bonus Points If You Have:
Demonstrated working knowledge and understanding of sterile injectable manufacturing procedures and processes
Knowledge of Good Manufacturing Practices {also cGMP}, validation, audit techniques, and working knowledge of statistics
Experience with audit processes and corrective action plans.
Strong problem-solving skills.
Knowledge of drug product requirements
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 ControlBreakthroughs 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
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.
For U.S. based jobs, view an overview of Pfizer’s U.S. benefits program (opens in a new window)