Perform GDP reviews of batch records, ensure compliance with quality standards, resolve documentation discrepancies, maintain review checklists, and support quality initiatives.
Use Your Power for Purpose
Pfizer is committed to ensuring every batch meets the highest standards of Good Documentation Practices (GDP). Your role will directly impact compliance and patient safety by maintaining accurate, complete, and consistent documentation throughout the batch review process.
What You Will Achieve
In this role, you will:
Here Is What You Need (Minimum Requirements)
Bonus Points If You Have (Preferred Requirements)
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 is committed to ensuring every batch meets the highest standards of Good Documentation Practices (GDP). Your role will directly impact compliance and patient safety by maintaining accurate, complete, and consistent documentation throughout the batch review process.
What You Will Achieve
In this role, you will:
- Perform comprehensive GDP reviews of batch records to ensure accuracy, completeness, and compliance with Pfizer Quality Standards and regulatory requirements.
- Verify that all critical data entries, signatures, and dates are properly documented and aligned with GDP principles.
- Identify documentation gaps or errors and collaborate with relevant teams to resolve discrepancies promptly.
- Ensure timely closure of batch record reviews to support uninterrupted product release.
- Maintain and update GDP review checklists and SOPs to reflect current standards and best practices.
- Document findings and provide clear feedback to manufacturing and quality teams.
- Support continuous improvement initiatives related to documentation quality and compliance.
Here Is What You Need (Minimum Requirements)
- High school diploma (or equivalent) with 5+ years of experience, or associate's degree with 3+ years, or BA/BS with 2+ years of experience.
- Strong knowledge of Good Documentation Practices and batch record requirements in pharmaceutical manufacturing.
- Attention to detail and ability to identify inconsistencies in documentation.
- Excellent technical writing and communication skills.
- Proficiency in Microsoft Office and electronic documentation systems.
Bonus Points If You Have (Preferred Requirements)
- Experience in batch record review within a GDP environment.
- Familiarity with electronic batch record systems and quality management tools.
- Strong analytical and problem-solving skills.
- Ability to work independently and manage multiple reviews under tight timelines.
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
Electronic Documentation Systems
Good Documentation Practices
MS Office
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