QA Product Release Pharmacist (Permanent) - Midrand, Gauteng
QA Product Release Pharmacist (Permanent) - Midrand, Gauteng
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1 Vacancy
Job Description
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
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iSanqa is your trusted Level 2 BEE recruitment partner dedicated to continuous improvement in delivering exceptional service. Specializing in seamless placements for permanent staff temporary resources and efficient contract management and billing facilitation iSanqa Resourcing is powered by a team of professionals with an outstanding track record. With over 100 years of combined experience we are committed to evolving our practices to ensure ongoing excellence.
Employment Type
Full-time
