Job purpose:The successful candidate will be responsible for ensuring adherence to the quality management system (QMS) and current Good Manufacturing Practices (GMP), as well as ISO 9001.Key Performance Areas:PRODUCT RELEASE:• Authorising product releases and record verification.• Manage and control the process for the quarantine, sampling and release of product for sale.• Review and release packaging material, raw materials, intermediate products and finished goods.• Inspection of retention samples as representative samples of the batch.• Recommend product recalls where products do not meet specifications.• Control the issuing of Labels and controlled printed materials (PIL, PI's, etc).• Serve as a member of the change control committee.QMS PRINCIPLES:• Implementation of and guidance in QA GMP and ISO principles.• Make decisions according to approved GMP requirements, SOP's and/or corporate procedures and principles, within the scope of Deputy Responsible Pharmacist.• Ensure compliance to GMP, with specific reference to radiopharmaceutical products - in-process inspections.• Prepare, update, review and approve procedures.• Update QMS via structured procedures.• Train on GMP and relevant SOP's and related topics.• Maintain and ensure compliance to Quality agreements.• Prepare for and participate in Management Review.• Lead or partake in risk assessments and validation activities, as appropriate.PRODUCT AND PROCESS PERFORMANCE:• Co-ordinate and control stability program.• Perform Annual Product Reviews.• Perform Trend Analysis of various quality parameters for products.• Compile monthly and quarterly reports.• Administer Continual Improvement System & lead or partake in CAPA and/or Deviation investigations.• Establish specifications.AUDITS AND PROJECTS:• Assist in conducting supplier & internal audits and preparing for audits by third parties.• Review new guidelines, outside inspection reports and current trends in GMP.• Assist the Project Groups on various projects, in respect of QA activities on new product development and new facilities.JOB REQUIREMENTS:Knowledge and skills:• Extensive knowledge of QA Principles within the ISO and GMP environment.• Knowledge of ISO requirements.• Knowledge of GMP requirements.• GMP training.Competencies:• The ability to communicate effectively and efficiently at all levels in the organisation as well as in supplier organisations.• The ability to utilise the correct computer software and the relevant functionality applicable to the outcomes required.• The ability to manage time effectively and efficiently in accordance with work priorities to ensure qualitative outcomes.• The ability to apply planning techniques to conduct effective planning of work outputs and resources.Minimum Qualifications and Experience:• B.Pharm degree (NQF 8) or equivalent.• Registered as a practicing pharmacist with SAPC.• GMP training.• At least 5 years' experience in a pharmaceutical manufacturing environment, of which at least 3 years are in a QA position.• Knowledge of ISO requirements.• Sound knowledge of GMP requirements.
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