Senior Laboratory Operations Specialist

2 days ago


Una, Gujarat, India beBeeQuality Full time ₹ 18,00,000 - ₹ 24,00,000

Job Summary:

We are currently seeking a seasoned Quality Control Manager to oversee daily laboratory operations, guarantee compliance with regulatory requirements, and lead investigations into quality issues.

Key Responsibilities:

  • Supervise daily QC lab activities including raw material, in-process, finished product, and stability sample testing.
  • Ensure adherence to Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and company Standard Operating Procedures (SOPs) in all QC activities.
  • Manage and review analytical data for accuracy, completeness, and compliance.
  • Lead investigations of out-of-specification (OOS), deviations, and laboratory incidents.
  • Approve/review laboratory reports, certificates of analysis (CoAs), and release documentation.
  • Coordinate with Quality Assurance, Production, Research and Development, and Regulatory teams.
  • Guarantee the proper calibration, qualification, and maintenance of lab instruments (HPLC, GC, UV, IR, etc.).
  • Prepare and face regulatory audits (FDA, WHO, EU GMP, etc.) and customer inspections.
  • Develop and train QC staff on current analytical techniques and regulatory requirements.
  • Maintain and monitor lab Key Performance Indicators (KPIs) including testing turnaround time, compliance rates, etc.


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