Sterile Product Quality Assurance Specialist

1 week ago

Ahmedabad, Gujarat, India beBeeSterile Full time ₹ 15,00,000 - ₹ 20,00,000
About the Role

As a Quality Assurance Specialist in our manufacturing environment, you will play a critical role in ensuring the production of high-quality sterile injectable products. Your primary responsibility will be to oversee and review batch manufacturing records, packaging records, and other documentation to ensure compliance with current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs), and regulatory requirements.

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. Strong analytical and problem-solving skills are essential for this role, along with effective communication and documentation skills. You should be able to manage cross-functional teams and prioritize tasks efficiently.

Main Responsibilities:

  • Batch Review and Approval: Reviewing and approving executed batch manufacturing records and batch packaging records to ensure completeness, accuracy, and compliance
  • Discrepancy Resolution: Coordinating with on-site teams to resolve discrepancies or missing documentation before batch release
  • Data Review: Reviewing electronic in-process control data, critical process parameter logs, and environmental monitoring results
  • Label Verification: Verifying product label templates, proofs, and electronic versions for accuracy against specifications and regulatory standards
  • Report Analysis: Compiling, reviewing, and analyzing electronic data for annual product quality review reports
  • Change Control: Reviewing, assessing, and approving electronic change control proposals via Quality Management System (QMS) software
  • Deviation Review: Conducting remote reviews of deviation reports, root cause analyses, and corrective action proposals
  • CAPA Planning: Approving CAPA plans in the QMS system and reviewing CAPA closure documentation
  • Audit Readiness: Ensuring remote audit readiness by reviewing documentation for alignment with cGMP, US FDA, and other applicable regulatory requirements

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