Senior Regulatory Compliance Officer

5 days ago

Karachi, Sindh, Pakistan beBeeCompliance Full time 15,000,000 - 25,000,000
Quality Assurance Senior Executive

We are seeking a highly skilled and experienced professional to join our team as a Quality Assurance Senior Executive.

Key Responsibilities:
  • Review and ensure accuracy of Out of Specification (OOS) and Out of Trend (OOT) documentation and investigations.
  • Evaluate and provide oversight for analytical method validations, method transfers, and stability studies.
  • Maintain compliance with regulatory guidelines (ICH, WHO, EU-GMP) and internal Standard Operating Procedures (SOPs).
  • Coordinate and support regulatory audits and customer inspections for laboratory systems and documentation.
  • Review and approve laboratory data, including raw data, chromatograms, and electronic records for integrity and compliance.
  • Support implementation and periodic review of Good Laboratory Practices (GLP) and data integrity controls in the lab.
  • Monitor compliance of laboratory equipment calibration, qualification, and maintenance programs.
  • Ensure timely investigation and closure of deviations, incidents, and Corrective Actions Preventive Actions (CAPAs) related to laboratory activities.
  • Conduct training and awareness sessions on laboratory compliance, documentation practices, and audit readiness.
  • Participate in change control assessments related to laboratory instruments, methods, and specifications.
  • Assist in developing and improving SOPs, quality manuals, and lab compliance checklists.
Required Experience, Knowledge & Skills:
  • Master's degree in Chemistry or Applied Chemistry, or equivalent.
  • 4–8 years of experience in pharmaceutical industry, preferably with experience in Quality Control, R&D Analytical Laboratory, or pharmaceutical compliance.
  • Sound knowledge of GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice), and ICH / WHO guidelines.
  • Proficient in handling OOS/OOT investigations, CAPA, change controls, and deviation management.
  • Strong understanding with analytical techniques (HPLC, GC, UV, etc.) and instrument qualification protocols.
  • Well-versed in data integrity practices, ALCOA+ principles, and electronic documentation systems.
  • Strong analytical, documentation review, and critical thinking skills.
  • Excellent verbal and written communication skills for cross-functional collaboration.
  • Self-driven, detail-oriented, and proactive in ensuring regulatory and procedural compliance.

The successful candidate will have strong leadership skills, excellent communication skills, and the ability to work collaboratively with cross-functional teams. The ideal candidate will also have experience working in a fast-paced environment, be self-motivated, and have a passion for delivering high-quality results.

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