Job Description

A Global pharmaceutical company is seeking a Quality Assurance Pharmacist. The Pharmacist will also take responsibility for Pharmacovigilance and Artwork

• Change Control: assess product related change proposals from a quality and GMP stand point.
• Deviation Management: evaluate independently the impact of all significant deviations generated and negotiate any actions required.
• Complaint handling: manage independently the external market complaint process by ensuring that all justified complaints requiring investigation are answered in a timely manner and that the investigation report is appropriate and meeting requirements
• Annual Product Reviews (APR): Review of APRs and ensure that APRs are timely generated and that required corrective or preventive actions are defined and implemented in a timely manner
• External Laboratory: Liaise with the local laboratory to ensure that post importation testing is carried out in a timeous manner as well as per current guidelines and specifications.
• Maintaining the working standard list and ensuring columns are sourced for new products.
• Validation approval: review and endorse any validation activities including transport validation.
• Audit support: Co-ordinate and facilitate local audits of laboratory lab as well as support during audits by regulatory body (i.e. SAHPRA and Pharmacy Council)
• Quality System support: Implementation and maintenance of the Quality Management System.
• Product Release: Batch documentation review, communicating with the local lab to ensure results are available on time. Interacting with the distributions sites to ensure stock is controlled and released on time, as well as support to the marketing team. Interact with the 3rd party manufacturer to ensure compliance.
• Creating and updating SOP's
• Working directly with marketing and supply chain to ensure timeous release of products.
• Ensuring Technical Agreements are in place and reviewed on a regular basis.

Responsibilities also includes Pharmacovigilance and artwork.

MNA Recruitment