Pfizer Quality Assurance Job For Chemistry & Pharma, Apply Online
Associate Manager – Quality Assurance
India – Chennai
Time type: Full time
Posted on: Posted Yesterday
Job Requisition ID: 4922417
Prior Job Description
This Pfizer Quality Operations position will support the Pharm Sci Small Molecules QO department by performing Quality Assurance activities associated with the Procedure Administrator, Documentation, and Records Management team member. Activities may include analytical method validation review/approval, instrument/equipment qualification, investigations, change control, SOPs, and ensuring adherence to regulatory and internal compliance standards at the Pfizer Indian Institute of Technology Madras Research Park (IITMRP). The candidate will partner with key business lines to provide QA GMP guidance and support. The candidate should possess sufficient knowledge of cGMP and have knowledge of scientific principles.
Location: Colleague will be based in IITMRP Chennai and follow a flexible working program of onsite and remote work.
ROLE RESPONSIBILITIES & SKILL SETS:
- Provides administration of the procedural documents in support of commitments, business, or project needs in a timely manner.
- Supports the management of PharmSci Active Library and other documentation systems for Business lines.
- Partners with Business Lines in the development, implementation, and management of their documentation and records to ensure ALCOA principles are adhered to as part of the documentation lifecycle.
- Awareness of DI and ALOCA principles.
- Basic understanding of cGMP requirements like 21 CFR part 11, 210 and 211, and ICH guidelines.
- Maintaining compliance at labs and during review of documents.
- Must have good communication and convincing skills.
- Well-disciplined and self-motivated attitude.
- Participate in the implementation of new initiatives and goals within the QA function and with business line partners to drive consistency, efficiency, and compliance.
- Manage own time to meet agreed targets and develop plans for work activities on own projects within assigned teams.
- Suggest improvements and conduct continuous improvement activities.
- Contribute to the development and compliance of quality and business line partner procedures.
- Provide support to Inspection Readiness efforts, internal audits & regulatory inspections as needed.
- Practice and encourage quality culture behaviors within quality and the business lines.
- Should have good command of MS Office operation – Excel, Word, and PowerPoint presentation preparation.
QUALIFICATIONS:
Education:
- Master of Science in Chemistry
- Master of Pharmacy in QA or Chemistry
Relevant experience: Relevant work experience in document management and procedure administration in healthcare
Work Location Assignment:
- Flexible
- On Premise
If you are interested in this position, please apply through the original notification.
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