Quality Assurance Specialist for Sterile Injectables

Job Summary

We are seeking a Quality Assurance Specialist to join our team. The ideal candidate will have in-depth knowledge of sterile injectable manufacturing processes and aseptic techniques, as well as expertise in validation methodologies and regulatory guidelines.

Key Responsibilities:

• Review and approve executed Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) submitted from manufacturing sites to ensure completeness, accuracy, and compliance with cGMP, SOPs, and regulatory requirements.
• Coordinate with on-site teams to resolve discrepancies or missing documentation before batch release.
• Review electronic in-process control (IPC) data, critical process parameter logs, and environmental monitoring results uploaded from the site.
• Verify product label templates, proofs, and electronic versions for accuracy against specifications and regulatory standards.
• Compile, review, and analyze electronic data for Annual Product Quality Review (APQR) reports, identify trends or recurring issues, and prepare remote review summaries for cross-functional teams.
• Review, assess, and approve electronic change control proposals via QMS software, evaluating potential impacts on validation, processes, and regulatory compliance.
• Conduct remote review of deviation reports, root cause analyses, and corrective action proposals, and track deviation trends for periodic reporting.
• Approve CAPA plans in the QMS system, ensuring they address identified issues with measurable effectiveness criteria, and review CAPA closure documentation to confirm adequacy of evidence.
• Review and approve Out-of-Specification (OOS) and Out-of-Trend (OOT) investigation reports submitted from the site, ensuring thorough root cause analysis and effective preventive measures.
• Ensure remote audit readiness by reviewing documentation for alignment with cGMP, US FDA, and other applicable regulatory requirements.
• Participate in virtual inspections and audits, providing requested documentation and clarifications.
• Maintain close coordination with on-site QA personnel to ensure timely resolution of documentation and compliance issues.
• Provide remote guidance to manufacturing site teams through virtual meetings, calls, and written communication.

Required Skills and Qualifications:

• Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.

About This Opportunity:

We offer a dynamic work environment that values collaboration, innovation, and excellence. Our team is passionate about delivering exceptional results and driving quality improvements in the pharmaceutical industry.

Preferred Qualifications:

• In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.
• Expertise in validation methodologies and regulatory guidelines (US FDA, cGMP etc.).
• Strong analytical and problem-solving skills.
• Effective communication and documentation skills.
• Ability to manage cross-functional teams and prioritize tasks.
• Proficiency in QMS tools and software.