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4 days ago
In this role, you will be responsible for ensuring the quality of in-process materials and products by reviewing and approving executed batch manufacturing records, coordinating with on-site teams to resolve discrepancies, and verifying product label templates against specifications.
You will also compile and review electronic data for annual product quality review reports, identify trends or recurring issues, and prepare remote review summaries for cross-functional teams.
- Key Responsibilities:
- Review and approve executed batch manufacturing records (BMRs) and batch packaging records (BPRs)
- Coordinate with on-site teams to resolve discrepancies or missing documentation
- Verify product label templates, proofs, and electronic versions against specifications
- Compile, review, and analyze electronic data for Annual Product Quality Review (APQR) reports
- Review and assess electronic change control proposals via QMS software
- Conduct remote review of deviation reports, root cause analyses, and corrective action proposals
- Approve CAPA plans in the QMS system and review closure documentation
- Review and approve Out-of-Specification (OOS) and Out-of-Trend (OOT) investigation reports
- Maintain remote audit readiness and participate in virtual inspections and audits
- Education: Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field
- Key Skills and Competencies:
- In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques
- Expertise in validation methodologies and regulatory guidelines
- Strong analytical and problem-solving skills
- Effective communication and documentation skills
- Ability to manage cross-functional teams and prioritize tasks
This is a challenging opportunity that requires exceptional organizational skills and the ability to work effectively in a team environment. If you have experience working in quality assurance and possess strong attention to detail, we encourage you to apply for this role.
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