Qa Product Release Pharmacist

Ultra Pharmaceutical And Medical Placements; Gauteng; Presencial; ZAR 420 000 - 600 000; Tempo integral

Resumo da oferta

Ultra Pharmaceutical And Medical Placements is seeking a qualified Professional to oversee the release of imported products, medical devices and critical starting materials, ensuring health, safety, quality and regulatory compliance. You will review CoA, temperature logs and post-import documents, and coordinate lab testing and sample handling.

The role requires a Bachelor of Pharmacy with at least 3 years of pharmaceutical industry experience, proficiency in MS Excel, and the ability to operate

Qualificações

• Bachelor of Pharmacy with minimum 3 years' pharmaceutical experience.
• Experience with quality releases and regulatory compliance.
• Strong attention to detail and documentation.

Responsabilidades

• Release of imported products, medical devices and starting materials.
• Review and maintain release specifications and TPN documentation.
• Coordinate with laboratories to ensure timely testing and sampling.
• Manage SAP stock master data and on-hold products.
• Approve or reject components and drug product containers.

Conhecimentos

MS Excel

Ability to work under pressure

Self-supervision

Formação académica

Bachelor of Pharmacy

Ferramentas

SAP

Descrição da oferta de emprego

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:

1. Temperature loggers
2. Original CoA from manufacturer
3. 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