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:
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
