Qa Product Release Pharmacist (Permanent) - Midrand, Gauteng

POSITION : Permanent / Onsite

COMMENCEMENT : ASAP

Purpose of Position : Ensure all pharmaceutical and related activities QA Product Release Pharmacist are undertaken as per acceptable national and cGMP principles and legislation as well as GMP guidelines.

Release of TPN ensure product safety quality and efficacy. Maintenance of all records related to release in an easily retrievable manner. Ensuring the in-process quality control is effective. MINIMUM REQUIREMENTS : B.

Pharm degree At least three years experience within the pharmaceutical industry Sound knowledge of GMP Knowledge of aseptic production would be advantageous Ability to multitask and problem solve Attention to detail Decisive Experience with MS Word Excel PowerPoint Outlook SAP Able to operate in a high-pressured environment Ability to work with minimal supervision.

Key Performance Areas

Release of TPN : Review of TPN documentation to ensure it has been compounded in accordance with SOPs GMP and regulatory standards; ensure patient safety; resolve queries and deviations; release of product in accordance with marketing / dispensary requirements.

Implementation of quality control : Ensure QA-IPC performs statutory quality control verification checks in the compounding centre; manage routine quality checks; initiate quality risk assessments as required.

Documentation / systems : Review applicable SOPs; ensure incorporation of new requirements; investigate / close CAPAs change controls and deviations.

SAP management of stock : Handling of all products released and quarantined in SAP to prevent dispatch of unreleased stock; ensure discard occurs within required timeframe after approval.

Product release : Authorization to approve / reject components containers closures in-process materials packaging labeling and products; ensure release cover is managed for efficient releases; ensure imported product release in line with demand.

Data review for imports : Review data related to import product to ensure safety quality and efficacy; review includes temperature loggers CoA post-import CoA sample dispatch to lab.

Staff management : Training and supervision of QA-IPC staff; draft / update job profiles and KPIs; performance feedback; manage leave / overtime.

Pharmacovigilance Compliance : Ensure yearly mandatory PV training; report ADRs to PV Compliance Officer within one business day of occurrence.

Key Skills LTC Pharmacy, Hospital Experience, Pharmacy Software, Continuous Improvement, Go, Infusion Experience, Pharmacy Residency, Training & Development, Order Entry, Epic, Clinical Pharmacy Experience, Compounding Medications.

#J-18808-Ljbffr