15 Oct
Clinigen
Pretoria
- 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: SOP’s, 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 company’s 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.
Requirements
EDUCATION & 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 driver’s 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
▶️ Quality Assurance Pharmacist
🖊️ Clinigen
📍 Pretoria