Summary
The Quality Compliance Pharmacist is responsible for ensuring compliance with Good Distribution Practice (GDP) and regulatory requirements across pharmaceutical and medical device operations. This includes support of quality systems, product release, validation, and supplier management. The role involves maintaining regulatory licenses, managing pharmacovigilance and vigilance activities, handling audits and CAPAs, and ensuring up-to-date documentation and training programs. The officer also supports compliance with MDR/IVDR, oversees change control processes, and ensures products meet quality standards before distribution, working cross-functionally with internal teams and external partners. The role will also support regulatory, medical information and pharmacovigilance requirements as applicable
Quality Management & Compliance
- Oversee Good Distribution Practice (GDP) activities for pharmaceutical and medical device products.
- Ensure temperature control and environmental monitoring of storage and distribution areas.
- Manage quality operations, including deviation/NC handling, root cause analysis, and implementation of corrective and preventive actions (CAPAs).
- Perform risk assessments for distributed products and processes in line with regulatory and company standards.
- Maintain and control documentation, including SOPs, records, and batch release documents.
- Lead and participate in internal and external audits, including preparation, execution, and follow-up on findings.
Regulatory
- Prepare, submit, and maintain facility licenses, registrations, and renewals with national and international regulatory bodies.
- Oversee compliance with Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) requirements.
Supplier & Warehouse Oversight
- Qualify and manage suppliers and third-party service providers, including audits and performance monitoring.
- Support warehousing operations to ensure GDP compliance, including good housekeeping, pest control, and material handling.
Product Release
- Ensure that pharmaceutical and medical device products meet quality and regulatory standards prior to release for distribution.
Change Control
- Manage the change control process for systems, products, and procedures, assessing potential risks and regulatory impacts.
Requirements:
- Qualified Pharmacist (PSI registered)
- Auditor Certified (e.g. ISO 9001 and/or ISO 13485 or pharma equivalent)
- Responsible Person eligibility
- 1-3 years experience of GDP/GMP/ MDR, IVDR and ISO systems
- Validation experience including computer system validation
- Flexibility to travel and ability to audit effectively
