Overview
Quality Assurance Pharmacist/Public Sector Jobs in Pretoria, South Africa at Isilumko Staffing
Position: Quality Assurance Pharmacist (Public Sector)
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.
• To 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 sample of 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.
• To make decisions according to approved GMP requirements, SOP’s and/or corporate
procedures and principles, within the scope of Deputy Responsible Pharmacist.
• To ensure compliance to GMP, with specific reference to radiopharmaceutical products – in
process inspections.
• Preparing, updating, review and approving procedures.
• Update QMS via structured procedures.
• Training on GMP and relevant SOP’s and related topics.
• Maintaining and ensuring 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.
• Compiling of monthly and quarterly reports.
• Administer Continual Improvement System & lead or partake in CAPA and/or Deviation
investigations.
• Establish specifications.
AUDITS AND PROJECTS
• To 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
Compencies:
• 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.
Title: Quality Assurance Pharmacist/Public Sector
Company: Isilumko Staffing
Location: Pretoria, South Africa
Category: Quality Assurance – QA/QC (Data Analyst), Healthcare (Data Scientist)
