Lab Qa Executive

Role & responsibilities

• Ensure compliance of laboratory activities with

  GMP, GLP, data integrity, and regulatory requirements

  .
• Review and approve

  analytical reports, raw data, specifications, SOPs, protocols, and laboratory records

  .
• Investigate and manage

  OOS (Out of Specification), OOT (Out of Trend), deviations, and laboratory incidents

  .
• Perform

  root cause analysis (RCA)

  and monitor implementation and effectiveness of

  CAPA

  .
• Review and approve

  change controls, risk assessments, and quality impact assessments

  related to laboratory operations.
• Conduct

  internal audits

  and support regulatory inspections by FDA, MHRA, WHO, and customer audits.
• Ensure timely

  calibration, qualification, and maintenance compliance

  of laboratory instruments and equipment.
• Monitor

  training compliance

  of laboratory personnel and ensure adherence to approved procedures and quality systems.
• Maintain and improve the

  Laboratory Quality Management System (LQMS)

  through periodic reviews and compliance monitoring.
• Coordinate with

  QC, Production, Regulatory Affairs, and other cross-functional teams

  to ensure product quality and regulatory compliance.

Preferred candidate profile

• Qualification:

  M.Sc. (Chemistry/Microbiology) or B.Pharm/M.Pharm.

• Experience:

  5-10 years in Pharmaceutical Quality Assurance, preferably in Laboratory QA.
• Strong knowledge of

  GMP, GLP, Data Integrity, CAPA, Change Control, OOS/OOT Investigation, and Regulatory Guidelines

  .
• Experience in handling

  regulatory audits and laboratory compliance activities

  .
• Good communication, documentation, and problem-solving skills.