Associate Manager Quality Control
- India - Vizag
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 engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver meets the highest standards of safety and efficacy.
What You Will Achieve
In this role, you will:
- Perform method transfers/ validations / method verifications to the complex analytical techniques
- Interpret and evaluate data for accuracy, precision, trends, and potential cGMP impact, recommending appropriate corrective actions.
- Ensure all documentation and quality records comply with Good Manufacturing Practices and Good Laboratory Practices and are filed according to existing policies.
- Review and revise Standard Operating Procedures, analytical methods, and related documents to keep them current.
- Conduct analyses on finished products, raw materials, and components, including data entry, review, and approval in a computerized database.
- Contribute to the completion of complex projects, manage time effectively to meet targets, and develop plans for work activities within a team, while exercising judgment with reliance on supervisor and working under their direction.
Here Is What You Need (Minimum Requirements)
- Master’s degree in chemistry/ pharmacy with 8-10 years of experience in Analytical Method Transfer / Validation)
- Qualified in multiple analytical techniques (HPLC-with Empower, GC, IC, ICP-MS, Potentiometry, UV‑Vis, FTIR, Karl Fischer, and pH meters)
- Demonstrated technical skills in method validation and testing
- Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures, and governmental regulations
- Conduct analytical method validation in accordance with ICH Q2 (R1/R2), USP, and EP standards, encompassing protocol preparation, execution, approval of validation summaries, and coordination with cross‑functional teams.
- Conduct test method GAP assessments against USP, EP, BP, and JP requirements for New Product Introduction (NPI).
- Execute and document analytical method verification and method transfer activities.
- Demonstrate knowledge of ICH Q9 (Quality Risk Management) and apply risk‑based principles for identifying, assessing, controlling, communicating, and reviewing quality risks throughout the product lifecycle.
- Handling of OOS and OOT through QMS.
- Perform identification, assay, purity, and related analytical tests using validated methods.
- Monitor critical process parameters (CPPs) and critical quality attributes (CQAs).
- Support process validation and troubleshooting activities; communicate analytical results promptly to Production and QA to ensure effective process control.
- Manage working standards in compliance with established procedures.
- Handle change control activities and ensure timely implementation and closure of related CAPA actions.
- Knowledge of Good Manufacturing Practices and its application standards, processes, and policies.
- Excellent organizational skills and strong ability to multi-task
- Strong written and verbal communication skills
- Proficiency with unique Quality Control instruments to meet accuracy specifications for sample management, retains management, interpretation, and evaluation
Bonus Points If You Have (Preferred Requirements)
- Experience with laboratory work, particularly using analytical HPLC (High Pressure Liquid Chromatography),GC,IC, ICP-MS techniques
- Proven track record in leading continuous improvement projects
- Strong knowledge of lean manufacturing principles, six sigma methodologies, and statistical analysis
- Strong problem-solving skills and attention to detail
- Ability to manage multiple priorities and meet deadlines.
- Excellent interpersonal skills and the ability to communicate effectively with colleagues at all levels
- Adaptability and willingness to learn new techniques and procedures
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.
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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)