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Your new companyA global pharmaceutical organisation committed to ensuring the highest standards of quality and compliance in the commercialisation of medicinal products. This company is dedicated to continuous improvement and regulatory excellence, working closely with health authorities, contract manufacturers, and internal stakeholders to uphold strict industry standards.Your new roleAs a Quality Assurance Specialist, you will be responsible for managing quality activities to ensure compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) for medicinal products. Your key duties will include:
- Overseeing the product release and compliance process, verifying documentation completeness, and ensuring adherence to quality standards.
- Maintaining and enhancing Quality Systems, including Change Control, Deviations, Complaints, Product Quality Reviews (PQRs), Recalls, and Returns.
- Acting as a liaison with Health Authorities, ensuring timely reporting of quality incidents and overseeing compliance with company policies.
- Managing risk assessment and documentation, supporting technical knowledge-sharing within the organisation
- Implementing and monitoring Corrective and Preventative Actions (CAPAs), tracking effectiveness, and preparing reports for senior leadership.
- Engaging in continuous improvement initiatives to drive operational excellence.
What you'll need to succeed
- Bachelor's degree in pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Biochemistry, or a related field.
- Minimum of 5 years of experience in Quality Assurance, Quality Control, or a related function within the pharmaceutical or healthcare industry.
- Certifications in GMP and GDP
- Strong understanding of regulatory affairs, quality assurance, and pharmaceutical guidelines.
- Proven experience managing quality systems, pharmaceutical product releases, and compliance-related activities such as Change Control, CAPAs, and Deviations.
- Demonstrated ability to lead or participate in quality improvement projects.
- Previous exposure to regulatory audits and interactions with Health Authorities is highly desirable.
What you need to do nowIf you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
