Quality Assurance Pharmacist (Public sector / Pharmaceutical Manufacturing)

SUMMARY:
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POSITION INFO:

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 related
• GMP training
• Registered as a practicing pharmacist with SAPC
• No less than 5 years' experience in a pharmaceutical manufacturing company, no less than 3 years' in a QA role

Knowledge: 

• ISO
• GMP
• QA principles 

Key skills:

• Communicate at all levels 
• Computer literate
• Time management
• Planning
• Attention to detail 

Key performance areas: 

• Ensuring adherence to quality management system and good manufacturing practices, ISO9001
• Authorize product releases and recording verifications
• Managing and controlling the process for quarantine, sample and release of products for sale
• Review and release packaging material, raw material, intermediate products and finished goods
• Inspection of retention samples as representatives sample of batch
• Recommending 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 Pharmacist
• Ensure compliance to GMP, with specific reference to radiopharmaceutical products - process inspections
• Prepare, update, review, approve procedures 
• Train on cGMP and relevant SOP and related topics
• Maintain and ensure compliance to quality agreements
• Prepare for and participate in management review
• Lead or partake in risk assessments and validations activities 
• Coordinate and control the stability program
• Preforming annual product reviews
• Performing trend analysis of various quality parameters of products
• Drafting monthly and quarterly reports
• Administer continual improvement system and lead or partake in CAPA / deviation investigations
• Establish specifications
• Assist in conducting supplier and internal audits, preparing for audits by 3rd parties
• Reviewing new guidelines, outside inspection reports and current trends in GMP
• Assisting the project groups on projects, QA activities on new product development and new facilities