Quality Assurance – Principal Releasing Pharmacist
Quality Assurance – Principal Releasing Pharmacist Permanent Position, 5 days/week, Office hours
An opportunity has arisen to join the Quality Assurance department as a Principal Releasing Pharmacist, reporting to the Head of QA. This position will have line management responsibility for a Releasing Pharmacist and a Quality Officer (NSCU Release).
The purpose of this role is to review and release extemporaneously compounded specials and specials batch products in line with MHRA regulations and customer requirements. This role is also responsible for the control of controlled drugs (CD) held on site.
The main duties include:
• Assessment through physical inspection, review of manufacturing records and Quality Control data to ensure that products comply with their specification and have been manufactured in accordance with Good Manufacturing Practice (GMP) and company procedures.
• Review customer orders to confirm appropriateness of supply and acceptability of dosage, formulation and route of administration.
• Confirm through physical inspection and document review that products have been produced in line with company procedures and that they meet requirements of cGMP and customer orders.
• Produce a Certificate of Conformance for batch and extemporaneously compounded products.
• Approval using computer systems of new formulations.
• Maintain stocks and registers of CDs and assist with disposal of CD materials in accordance with statutory requirements.
• Check CD orders for dispatch.
• Release of compounded batch products following completion of QC testing
• Assisting with the investigation of Customer Complaints, Quality Incidents, deviations and OOS/OOE/OOT.
• Updating, generating and review of SOPs.
• Working closely with production management to resolve issues.
The ideal candidate will have the following experience and qualifications:
• 2-3 years experiences as a Registered Pharmacist
• Good understanding of the Home Office regulations for Controlled drugs.
• Experience of Line Management
• Good communication skills
• An awareness of Good Manufacturing Practice and MHRA guidance for Specials (Guidance note 14) would be an advantage
To apply please send your CV marked Janet Box, Head of QA either to the address below or via email: mailto:firstname.lastname@example.org
Closing date for applications: 25 November 2019
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