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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