Group Manager - Quality Assurance
- India - Vizag
QA Batch Release Manager
Role Summary:
Primarily responsible for managing the daily activities of the QA Batch Release as it relates to releasing commercial batches to market. This includes final approval of audited batches records prior to release, and revising standard operating procedures, communicating with various departments when exceptions are initiated or being resolved. Develop succession planning for the Batch Release Quality Unit.
What You Will Achieve
In this role, you will:
Lead and provide Oversight for Batch Release activities to ensure compliance to cGMP systems and procedures.
Organize the workflow of the QA Batch release department and communicate effectively with the team and management regarding the progress and issues.
Ensure that support required for approval of investigation are provided and disposition is performed against the specified batches.
Ensure any deviations and change control associated with the product are communicated effectively and timely for disposition decision.
Work with Responsible persons and the Site Quality Assurance Deviations/ Investigations, CAPA, change controls, Material management, Laboratories, Operations, Regulatory Assurance and Validations etc. to ensure all batches requiring restriction are identified, and upon, approval of requirements, all restrictions are lifted.
Work with Quality Operations teams to ensure compliance with respect to materials, area, equipment, monitoring conditions, people, processes, and procedures associated with the Batch manufacturing.
Work with Manufacturing/ Operations to resolve questions and/or determine if exception reports (ERs) are needed.
Develops goals and objective for the batch release team to obtain maximum efficacy from departments including delivery of cost saving initiatives.
Implement and maintain processes and systems to ensure adequate Management review and the identification of follow-up actions
Identify and implement potential improvements in processes or products, taking calculated risks to develop innovative ideas
Manage the performance of direct reports through goal setting, coaching, and ongoing assessment, recognizing the need for development and creating development plans
Communicate effectively by soliciting input, explaining complex concepts, and persuading others to adopt a point of view, while sharing own perspectives and rationale
Here Is What You Need (Minimum Requirements)
B. Pharm/M. Pharm / M.Sc. in Sciences with preferably 10 + years of experience in Manufacturing Quality/Quality Control/ Production or in Quality Assurance of a sterile dosage manufacturing facility
Working knowledge of current Good Manufacturing Practices (cGMP) for a pharmaceutical industry
Extensive knowledge of corporate quality systems that are applicable to the quality unit and the production operations serviced
Strong collaboration, relationship management, and interpersonal skills
Strong people management experience
Excellent written and oral communication skills
Strong computer proficiency skills in MS Office, Word, Excel, Access, Project, Trackwise or equivalent
Bonus Points If You Have (Preferred Requirements)
Master's degree with a solid understanding of sterile dosage manufacturing facility
Strong analytical and problem-solving skills
Ability to work independently and make decisions
Excellent organizational and time management skills
Experience in interfacing with regulatory agencies during audits
Ability to drive continuous improvement initiatives
Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
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)