GMP Auditor

RFQ/OBP369/2025/26

Procurement Description:A full system Good Manufacturing Practices gap assessment audit pertaining to Distribution, Stores/Warehouse, Packaging & QA Departments Develop a GMP Roadmap with detailed action plans to attain GMP Certification Provide guidance on how GMP requirements can be met Review and update the Quality Systems to align to GMP requirements Provide GMP training to the QA Department A GMP Auditor with a degree in pharmacy or life sciences, an extensive knowledge of ICH, EMA & PIC/s regulations is sought. She/he must have specialized experience in pharmaceutical manufacturing, be trained in audit methodologies (e.g., ISO 19011), possess strong technical knowledge in areas like sterile manufacturing, and demonstrate competency in data integrity, quality systems, and risk assessment.  Core Specifications and Qualifications: Education: Bachelor's degree or higher in Pharmacy, chemistry, Biology, or related technical field. Regulatory Knowledge: In-depth understanding of GMP regulations (e.g., EU GMP Part I/II, FDA 21 CFR 210/211, PICS). Experience: Proven experience in pharmaceutical manufacturing, Quality Assurance or Quality Control. Auditor Training: Formal training in audit techniques (planning, reporting, questioning) and, ideally, certification (e.g., Lead Auditor). Specialized Knowledge: Familiarity with specific technologies (e.g., HVAC, Water systems, sterile filling) and Data Integrity. Audit Experience: Practical experience including shadowing or auditing under supervision and/or as Lead (Min 5 years local GMP audits and Min 3 years international GMP audits).  Key Responsibilities and Skills: Risk-Based Auditing: Ability to focus on high-risk areas during supplier or internal audits. Technical Proficiency: Meticulous review of batch records, deviation reports, and validation documents. Soft Skills: Objectivity, strong communication skills, value adding and firm decision-making. Data Integrity: Expertise in detecting falsification, data deletion, and ensuring compliance.  Recommended Certifications: ECA Certified GMP Auditor APIC Certified Auditor IRCA/Exemplar Global/UKAS Certified Auditor  IRCA/Exemplar Global/UKAS Certified Lead Auditor (will be advantageous) 

Request for Quote

2026/02/19 15:00:00

No

RFQ/OBP369/2025/26