Senior In-Process Quality Assurance Professional

13 hours ago


Tiruchi, Tamil Nadu, India beBeePharmaceutical Full time ₹ 15,00,000 - ₹ 20,00,000
Job Overview

Quality Assurance Specialist

This position is responsible for ensuring the quality of in-process products and facilitating collaboration among cross-functional teams.

Key Responsibilities
  • Review and approve batch records and packaging records to ensure completeness, accuracy, and compliance with regulatory requirements.
  • Coordinate with on-site teams to resolve discrepancies or missing documentation before batch release.
  • Analyze electronic data for trends or recurring issues and prepare summaries for cross-functional teams.
  • Review and assess 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.
Requirements
  • 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 guidelines (US FDA etc.).
  • Strong analytical and problem-solving skills.
  • Effective communication and documentation skills.


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