Sr. Associate Quality Assurance
- India - Vizag
Use Your Power for Purpose
Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.
What You Will Achieve
In this role, you will:
Evaluate and review clinical and commercial drug batches to ensure compliance with established specifications.
Conduct rigorous sampling and statistical process control procedures to identify deviations from standards.
Approve investigations and change control activities to maintain compliance with configuration management policies.
Contribute to moderately complex projects, managing time effectively and developing short-term work plans.
Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts.
Investigate and document Quality Assurance deviations, escalating issues to the Quality Assurance Lead as needed.
Ensure regulatory compliance with current Good Manufacturing Practices (GxP) and provide Quality Review and oversight of site documentation to meet global regulatory and Pfizer quality standards.
Here Is What You Need (Minimum Requirements)
Bachelor's Degree in Sciences/ Pharmacy with Minimum 6 to 8 years in Pharma/ Biotech / Master's Degree in Sciences/ Pharmacy with Minimum 5 to 7 years in Pharma/ Biotech
Change Management process
Risk assessments principles and tools
Validation of manufacturing equipment’s
Drug Product Process validations
Regulatory requirements
Bonus Points If You Have (Preferred Requirements)
Strong Interpersonal skills
Ability to communicate effectively with all levels within the organization.
Compliance driven approach , knowledge on cGMP and regulations.
Knowledge in validation principles and practices related to the Equipment & Utility Qualifications, Water system, HVAC system.
Understanding of Drawings and layouts of manufacturing area, air flow, material flow, personal flow, building management system for real-time monitoring of manufacturing areas.
Fundamental knowledge on manufacturing activities like dispensing, solution preparation , filling, terminal sterilization, visual inspection, labelling and packing.
Understanding of design and engineering aspects, basic knowledge of equipment construction, working principle and maintenance of equipment.
Knowledge of various Quality tools required for investigations
Technical Writing- Ability to create documentation that is accurate, complete, unambiguous, and as concise as possible aimed to be understood by any level of organization.
Knowledge in Change control assessment
Interpersonal Skills: Effective communication with all staff from different levels and builds constructive and effective relationship.
Managerial Skills: Persistent approach to resolving issues, Effective situation handling capabilities, strong time management skills.
Written communication: Ability to write well-Structured technical reports.
Holds people accountable: Clearly assigns responsibility for tasks and decisions; sets clear objectives and measures; Monitors process, progress and results
Acts Decisively: Makes decision m a timely manner based on available information.
Grows Self: Identify Individual development needs and create a plan and work towards achieving those objectives
·Grows others: Provides challenging and stretching tasks and assignments.
Self-accountable & Proactive approach.
Critical thinking and Compliance mindset.
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)