- 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.
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