One of our state owned clients are in need of an experienced and registered Quality Assurance Pharmacist towards Pretoria.
Qualifications and experience:
B.Pharm degree or relatedGMP trainingRegistered as a practicing pharmacist with SAPCNo less than 5 years' experience in a pharmaceutical manufacturing company, no less than 3 years' in a QA roleKnowledge:
ISOGMPQA principles Key skills:
Communicate at all levels Computer literateTime managementPlanningAttention to detail Key performance areas:
Ensuring adherence to quality management system and good manufacturing practices, ISO9001Authorize product releases and recording verificationsManaging and controlling the process for quarantine, sample and release of products for saleReview and release packaging material, raw material, intermediate products and finished goodsInspection of retention samples as representatives sample of batchRecommending product recalls where products do not meet specifications Controlling the issuing of labels and controlled printed materials Serving as a member of the change control committee Implement and guide: NTP in QQA GMP and ISO principles Make decisions according to approved cGMP requirements, SOP's and / or corporate procedures and principles, within scope of Deputy Responsible PharmacistEnsure compliance to GMP, with specific reference to radiopharmaceutical products - process inspectionsPrepare, update, review, approve procedures Train on cGMP and relevant SOP and related topicsMaintain and ensure compliance to quality agreementsPrepare for and participate in management reviewLead or partake in risk assessments and validations activities Coordinate and control the stability programPreforming annual product reviewsPerforming trend analysis of various quality parameters of productsDrafting monthly and quarterly reportsAdminister continual improvement system and lead or partake in CAPA / deviation investigationsEstablish specificationsAssist in conducting supplier and internal audits, preparing for audits by 3rd partiesReviewing new guidelines, outside inspection reports and current trends in GMPAssisting the project groups on projects, QA activities on new product development and new facilities