
Sterile Injectable Quality Assurance Specialist
13 hours ago
Job Opportunity
We are seeking an experienced professional to join our team as a Quality Assurance Specialist. The ideal candidate will be responsible for ensuring the quality and compliance of our manufacturing processes. This involves reviewing and approving executed Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs), coordinating with cross-functional teams to resolve discrepancies or missing documentation, and verifying product label templates for accuracy against specifications and regulatory standards.
Main Responsibilities:
- Review and approve BMRs and BPRs to ensure completeness, accuracy, and compliance with cGMP and regulatory requirements.
- Collaborate with on-site teams to address discrepancies or missing documentation before batch release.
- Verify product label templates, proofs, and electronic versions for accuracy against specifications and regulatory guidelines.
- Compile, review, and analyze data for Annual Product Quality Review (APQR) reports, identify trends or recurring issues, and prepare summaries for stakeholders.
Required Skills:
- Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.
- In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.
- Expertise in validation methodologies and regulatory frameworks.
- Strong analytical and problem-solving skills.
- Effective communication and documentation skills.
- Ability to manage cross-functional teams and prioritize tasks.
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