RELEASE PHARMACIST (BH) IN SOUTH AFRICA

Job Position: Release Pharmacist Ref: 1998 Location: Port Elizabeth Salary: Commensurate with experience and qualification Qualifications / Requirements: • Relevant qualifications and experience – Please see Key Performance Area’s Key Performance Areas: • Release of production batches • Assessment should embrace all relevant factors including production conditions, results of in-process testing, review of manufacturing, packaging and laboratory documentation and compliance with finished product specification • When all required parameters are satisfied including the documentation audit, the Release Pharmacist may recommend release of the product from its quarantine status • Approval and release of: - Third party manufacture products - Printed packaging - Intermediates • Responsibility for ensuring that the following requirements with regards to release of finished products have been met • The marketing authorization and the manufacturing authorization requirements for the product have been met for the batch concerned • The principles and guidelines of GMP have been followed • The principal manufacturing and testing processes have been validated • All the necessary checks and tests have been performed and account taken of the production conditions and manufacturing records • Any planned changed or deviations in manufacturing or quality control have been notified in accordance with the QMS before any product is released • Any additional sampling, inspection, tests and checks have been carried out or initiated, as appropriate, to cover planned changes and deviations • All necessary production and QC documentation has been completed in line with the various SOP’s • Participate in internal audits • All relevant factors have been considered, including any not specifically associated with the output batch directly under review • Involvement in decision making of rejected goods, materials and components • General process evaluation – this includes reporting of observed deficiencies to the correct persons and follow-up on corrective action, liaising with production where necessary • Involvement in project decisions which may affect the quality of product • Review of plant systems and procedures and other documentation • Shared responsibility with production for the investigation into a solution of quality problems as well as preventative planning and action • Provision of assistance to production with pharmaceutical cover when so necessary e.g. compounding, line opening, dispensing • Input into factory training needs • Co-ordination, checking and sign-off of certificates of analysis and certificates of conformance for 3rd party manufactured products and exports • Transfer of released stock from quarantine to the finished goods warehouse on the computer system • Approval of deviations • Amending / updating and checking amendments to batch manufacturing records Reply to this ad with your CV or request our email address! Please also send us a recent, colour, head and shoulders photograph of yourself.