09/03/2026
Job Opening: Manager Compliance
Location: Sunder Industrial Estate Lahore
Job Role:
We are seeking an experienced Manager Compliance to oversee quality compliance activities. The role will ensure adherence to GMP, regulatory requirements, and internal quality systems, while supporting audit readiness and continuous improvement across operations. Compliance manager will maintain quality systems, manage audits, and ensure adherence to pharmaceutical regulatory standards.
Technical requirement:
1. Data Integrity & HPLC Audit Trails: Enforce ALCOA+ standards across all laboratory operations.
2. Perform routine, forensic-level reviews of HPLC/GC audit trails to detect unauthorized to check audit trails.
3. Data Governance Policy: Design and implement a site-wide Data Governance framework covering the full data lifecycle—from raw electronic capture to long-term archival.
4. Quality Risk Management (ICH Q9): Facilitate formal risk assessments (FMEA/HAZOP) for site operations, utility systems, and supply chains as per ICH Q9 guidelines.
5. Annual Product Quality Reviews (APQR): Execute rigorous APQRs; analyzing statistical trends in yields, deviations, and stability data to verify validated state and process capability
6. Validation Management: Method Validation: Lead protocols for USP/BP/EP analytical method transfers, ensuring Accuracy, Precision, and Robustness.
7. Process Validation: Oversight of Stage 1 (Design), Stage 2 (Qualification), and Stage 3 (Continued Process Verification).
8. Media Fill & Aseptic Trials: Govern Media Fill Trial compliance (ISO 13485/Annex 1); managing simulation protocols, growth promotion testing, and failure investigations.
9. Computerized System Validation (CSV): Maintain GAMP 5 compliance for all automated manufacturing and lab software (LIMS, ERP, QMS).
10. Regulatory Liaison: Primary lead for FDA, EMA, and WHO inspections; managing the "War Room" and ensuring zero critical observations through proactive CAPA tracking.
11. Site Change Control: Evaluate all technical changes (equipment, materials, or processes) for regulatory impact before implementation.
Technical Profile:
Pharm-D/ bachelor's or master's degree in chemistry
08-10 Years’ relevant experience in the field of QA compliance and QC
Mastery of EU GMP Annex 1,21 CFR Part 11 and PIC/S
