Group Manager - Quality Assurance

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/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 Control Pfizer careers are like no other. In our culture of
individual ownership, we believe in our ability to improve future healthcare,
and potential to transform millions of lives. We’re looking for new talent to
join our global community, to unearth new innovative therapies that make the
world a healthier place.