A leading healthcare organisation is looking for a QA Product Release Pharmacist to join their team in Midrand.
Purpose of the Role
Release of all imported products, medical devices, and all critical starting materials /consumables to ensure product safety, quality and efficacy. TPN documentation review and release as required. Maintenance of all laboratories, records and samples related to release in an easily retrievable manner.
Release of import product Ensure imported product is released in accordance with logistics and marketing demand. Review of data related to import product thus ensuring safety, quality and efficacy thereby ensuring that regulatory requirements are met, the review includes but is not necessarily limited to:
- Temperature loggers
- Original CoA from manufacturer
- Post importation CoA
Application for and maintenance of post importation exemptions Ensuring that methods utilized by laboratory are in accordance with registered methods. Update of product release specifications as required. Sending and tracking of samples to laboratory to ensure there are not unnecessary product release delays
Release of medical devices Maintenance of product release specifications for all medical devices Release of medical devices in accordance with specification Ensuring that all medical devices released are from approved suppliers in accordance with approved supplier list.
Release of all critical starting material / consumables Drawing up and maintaining release specifications for all critical starting materials and consumables as defined by the approved supplier list together with the Microbiology manager where required Release of all critical starting materials and consumables in accordance with release specifications to ensure that these materials do not compromise any production process or product safety Quality and Efficacy.
Management of labs Liaison with laboratories to ensure testing of product is conducted within given timeframe Ensuring that laboratories are supplied with the required columns and standards such that product release is not delayed Ensure that purchase orders are created and approved for all required consumables for laboratories to conduct testing. Manage quotes, invoices and costing with the laboratories in accordance with SLAs in place and the annual budget Ensure Analytical method Transfers are completed by the required laboratory and approved for all products tested
Management of retention samples Ensuring that retention samples required of released products are stored in a manner that renders them easily retrievable and are not compromised Ensure that the retention sample cage is managed and that retention samples are discarded on a regular basis in accordance with required retention periods and are discarded in a manner that is in compliance with waste management processes
Release of TPN Review of TPN documentation to ensure product has been compounded in accordance with cGMP and regulatory standards. Ensure patients’ safety regarding TPN administration by reviewing documentation and ensuring all investigations and deviations are documented, approved and are of a nature that will not affect product safety Resolution of all queries resulting from TPN compounding thereby ensuring product safety Release of product in accordance with marketing/dispensary requirements
Documentation/systems Review/approve of SLA’s and related agreements with third party suppliers. Annual review of full Batch manufacturing records for FKSA registered products produced by FKMSA and other Third Parties Review of applicable SOP’s ensuring that new requirements are incorporated and taking Global requirements into consideration. Investigation, closure and follow up on applicable CAPA, change controls and deviations to ensure timely closure and effectiveness of corrective action
SAP management of stock Handling of all products and materials released and placed on hold within the SAP system to ensure there is no dispatch of stock that has not been released. Ensure that discard of stock takes place within specified timeframe after approval of discard has been obtained. Management of QA product master Data in the SAP system. This includes loading new product code data such as Sampling plans, Inspection plans etc.
Product Release Authorization to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling and drug products
Skills & Experience: Bachelor of Pharmacy Minimum of 3 years’ experience within the pharmaceutical industry Minimum of Intermediate Level MS Excel Operating in a high pressurized environment Operating with minimal degree of supervision Monthly, yearly, and strategic planning
Desired Skills:
- quality assurance
- quality pharmacist
- medical device
- Bpharm
- bachelor of pharmacy
- qa pharmacist
Employer & Job Benefits:
- Basic salary
- medical aid
- provident fund
- group life cover
- performance bonus
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