Responsible for reviewing product development documents, ensuring data integrity compliance, conducting audits, and maintaining quality assurance standards in pharmaceutical manufacturing.
ROLE SUMMARY
ROLE RESPONSIBILITIES & SKILL SETS
QUALIFICATIONS
Education:
Relevant experience:
Location: On premise
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
- Responsible for reviewing documents related to product development, analytical data (including electronic data, chromatographic data, and audit trails), as well as instrument and equipment qualification
- Accountable for ensuring data integrity compliance and adherence to SOPs during the review of both hard copy and electronic records
- Conduct periodic system audit trail reviews and ensure compliance with 21 CFR Part 11 requirements
- Liaise effectively with global BL and OQ colleagues to achieve organizational objectives
- Maintain a thorough understanding of ICH quality guidelines and relevant regulatory guidance on microbiology method development pertaining to sterility, BET, CCIT, and associated development requirements
- Possess in-depth knowledge regarding sterility requirements and filter validation activities in accordance with PDA technical reports
- Demonstrate familiarity with requirements for sterile ANDA product development and combination products
- Exhibit strong proficiency in MS Office applications, including Excel, Word, and PowerPoint presentation preparation
ROLE RESPONSIBILITIES & SKILL SETS
- Awareness of DI and ALOCA principles
- Basic understanding of cGMP requirements, including 21 CFR part 210 and 211, ICH guidelines, and sterile product requirements
- Maintain compliance in laboratories and during document review
- Ability to perform statistical evaluation and analysis of analytical data during method development and validation review
- Effective communication skills.
- Adherence to discipline and self-motivation.
- Participate in the implementation of new initiatives and goals within the QA function and with business line partners to support consistency, efficiency, and compliance.
- Manage time to meet agreed targets and plan work activities for projects within assigned teams.
- Suggest improvements and participate in continuous improvement activities.
- Contribute to the development and compliance of quality and business line partner procedures
- Provide support for inspection readiness efforts, internal audits, and regulatory inspections as required
QUALIFICATIONS
Education:
- Master of science in chemistry
- Master of pharmacy
Relevant experience:
- Relevant work experience in an analytical data review and Technology transfer and cGMP pharmaceutical sterile manufacturing area
Location: On premise
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
Top Skills
MS Office
Pfizer Chennai, Tamil Nadu, IND Office
Chennai, India
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