Chief Quality Assurance Specialist
19 hours ago
The Quality Compliance Pharmacist plays a pivotal role in ensuring adherence to Good Distribution Practice (GDP) and regulatory requirements across pharmaceutical and medical device operations.
Key Responsibilities
- Oversee GDP activities for pharmaceutical and medical device products, including 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.
Regulatory Requirements
- 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.
- Monitor regulatory updates and assess business impact (regulatory intelligence).
Vigilance & Safety
- Manage pharmacovigilance and medical device vigilance activities, including adverse event reporting and follow-up.
- Handle product complaints and coordinate recalls in line with regulatory expectations and internal procedures.
Validation & System Control
- Oversee validation of systems, equipment, and processes involved in distribution.
- Ensure compliance with data integrity.
Training & Development
- Develop, maintain, and deliver training programs to ensure all staff comply with GDP, GMP, and quality policies.
- Ensure training records are complete and up-to-date.
Requirements
- Auditor Certified (e.g. ISO 9001 and/or ISO 13485 or pharma equivalent)
- Responsible Person eligibility
- Qualified Pharmacist
- 1-3 years experience of GDP/GMP/MDR, IVDR and ISO systems
The ideal candidate will possess strong knowledge of GDP, GMP, MDR, IVDR, and local regulatory frameworks, as well as excellent communication, organizational, and documentation skills.
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