Job Description

• Responsible for QA batch release of manufactured products received from international suppliers (Principals) including: Registered Medicine, Unregistered Medicine (Section 21) and Medical Devices.
• To provide administrative support relating to the Quality Management System (QMS) and Regulatory Affairs.
• Support Group Quality Manager with responsibility for 100% compliance of the business in terms of cGMP and to comply with all SAPC, SAHPRA and DOH requirements.
• Assist RP and Quality Manager in ensuring compliance to all Regulatory and Quality Management System (QMS) requirements, within Equity.
• Assist the Group Quality Manager to ensure 100% compliance in terms of GMP.
• Assist the Group Quality Manager to ensure 100% compliance with all SAPC, SAHPRA and DOH requirements.
• Responsible for the release of finished product batches (registered/ unregistered medicine).
• Responsible for ensuring that the requirements with regards to release of finished registered/ unregistered products have been met and are according to the approved procedure.
• Compile and review of batch documentation.
• Ensure all required parameters are satisfied including the documentation audit, before releasing the product from its quarantine status.
• Co-ordination, checking and sign-off of Certificates of Analysis and Certificates of Conformance for third party manufactured products.
• General process evaluation. This includes reporting of observed deficiencies to the correct persons and follow-up on corrective action, liaising with principals (suppliers) where necessary.
• Assist with the Approval and Release of 3rd party manufacture products printed packaging and intermediates.
• Monitoring and auditing compliance to both regulatory requirements and in-house standards with regards to the release and recall procedure.
• Transfer of released stock from quarantine to the finished goods warehouse on the computer system - SAGEx3.
• Ensuring good relations and communications with all Principals (suppliers) and members within the company and responding politely and in a timely fashion to internal and external customers.
• Responsible for processing Customer Returns and Rejections.
• Involved in decision making of rejected goods and medicine, as well as assessing customer returns.
• Responsible for liaising with the local laboratories and ensuring post-importation readiness.
• Assist with current Final Product Release Specs and Methods at local testing laboratories.
• Assist with Laboratory Services Agreements.
• Source and obtain the applicable reference standards for each product required for post-importation testing.
• Assist with Analytical Method transfers (launch readiness).
• 3rd Party Suppliers / Service Providers review and approval (Vendor Qualification).
• Assist the Group Quality Manager to manage and control QMS related functions (Risk-Assessments, Change Controls, Deviations, CAPAs, Quality Agreements, Product and Service Complaints, Audits).
• Manage and control QA Documentation: SOPs, Forms, Log Sheets, Templates (writing, reviewing and approving and SOP Training).
• Assisting and involved with technical customer and product queries and complaints.
• Ensure responding to enquiries in a timely manner, giving feedback on customer complaints in order to maintain the companys reputation for customer service and high-quality products.
• Assist with Product Quality Reviews.
• Involvement in project decisions which may affect the quality of product.
• Participating in Regulatory-Authority, internal and external audits.
• Shared responsibility with regulatory for the investigation into a solution of quality problems and challenges as well as preventative planning and action.

RequirementsEDUCATION & EXPERIENCE

• B.Pharm Degree.
• Registered Pharmacist with South African Pharmacy Council.
• Previous experience/ background in the Pharmaceutical Industry, specifically Quality Assurance.
• Completed Community service as a Pharmacist.

SKILLS/ COMPETENCIES AND BEHAVIOURAL QUALITIES REQUIRED

• Sound knowledge of MS Office (Excel, Word, Powerpoint and Outlook).
• Detail orientated and organised.
• Analytical and Good Interpretation skills.
• Prioritise workload to tight deadlines.
• Can perform under pressure and prioritise accordingly.
• Innovative, problem solving and decision-making skills.
• Good communication and interpersonal skills.
• Cross functional ability.
• Disciplined and Assertive.
• Perseverance and persistent in decision-making.
• Assertive and Proactive.
• Must be able to work outside office hours when required or requested to do so.
• Valid drivers license and own vehicle.
• Available after hours via cell phone in case of emergency only.

Benefits

• Private Health Insurance
• Paid Time Off
• Training & Development
• Performance Bonus

Clinigen