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Quality assurance specialist

Anvers
Apsida Life Science
Publiée le 4 novembre
Description de l'offre

Apsida Life Science have partnered with a leading pharmaceutical company to provide the following role: Job Title: (QP)/ Quality Assurance Specialist Location: Belgium Duration: 12 months + Company Overview: The client is a global biopharmaceutical organization dedicated to discovering and developing innovative medicines. The company invests heavily in research and development, with a strong focus on areas such as metabolic disorders, oncology, neuroscience, and immunology. Its therapies are widely available across international markets, and it continues to expand its portfolio with breakthrough treatments that address some of the world's most pressing health challenges. Responsibilities Ensure compliance with EU/Belgian regulatory requirements, GMP/GDP standards, and company procedures within PR&D activities. Perform QP responsibilities, including certification, batch release (e.G., EP and China release), approval of deviations, change controls, retest extensions, and study/country additions. Oversee quality events, CAPAs, audits, inspections, and quality metrics, ensuring timely reporting and corrective actions. Collaborate with internal QA, regulatory, and global quality functions, as well as external partners, to support compliance, inspections, and alliances. Promote a strong quality culture by maintaining oversight of clinical trial material, product release, documentation, and risk management to safeguard product safety and effectiveness. Participate in regulatory inspections, self-inspections, and partner audits, providing QP oversight and ensuring audit readiness. Support preparation and issuance of quality certifications, declarations, and equivalency confirmations in line with EU GMP standards. Provide quality support for collaborations, alliances, and expanded access programs, ensuring adherence to company and regulatory expectations. Safeguard confidentiality, enforce safety and environmental requirements, and actively contribute to continuous improvement in quality processes. Manage retention and reference samples at EU packaging sites to ensure compliance with regulatory and company standards. Assist in product recall coordination and ensure effective communication with authorities on critical quality or regulatory issues. Requirements Scientific Master's Degree in Pharmacy, Qualified Person. Minimum 1 year in pharmaceutical environment. Fluent in English (spoken and written). If you are interested in learning more, please reach out to Mufaro Mpofu: Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost effective, high quality and trusted recruitment service that puts the candidate journey at the heart of the recruitment process.

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