CAPE TOWN

PHARMACEUTICAL INDUSTRY

A leading Pharmaceutical company is looking for dynamic, above average and suitably qualified/experienced QA Coordinator to join their progressive team of highly skilled individuals. If you are looking for a progressive environment with a company at the top of their game, then this position is for you!

MINIMUM REQUIREMENTS:

Minimum of 1-3 years’ work experience in a quality control/quality assurance in pharmaceutical environment essential
Relevant tertiary qualification
Strong document management experience
Experience with lot releases, PQR’s and SOP’s
High computer literacy enable to effectively use Excel
Up to date knowledge of validation, GMP, and GLP
Sound knowledge of most recent analytical laboratory techniques, packaging analysis, in-process requirements and production controls
Highly accuracy/attention to detail
Excellent communication skills (verbal and written)
Solid report-writing skills
Auditing exp.


RESPONSIBILITIES WILL INCLUDE:

Create, review and update Lot Release Forms per product
Coordinate the sampling of incoming goods at the contract distributor and/or packer
Coordinates the analytical reference standards at the various contract laboratories
Coordinate the testing for post-importation requirements and documentation thereof with contract laboratories
Compile and maintain the samples register
Liaise with Third party contractors
Coordinate, compile and review all batch documentation relating to the lot release of all products - manufacturing, packaging and analytical records - in compliance with registered dossiers
Performs Bulk material inspections before packaging and liaise with contractors, maintain registers
Performs final packed product inspection, maintains the product trend charts and update the lot release summary for all products on an ongoing basis
Coordinate the timeous final product release to market of all products by the Finished Product Release Pharmacist
Ensuring starting materials and bulk products are promptly released
Attend to and resolve Complaints
Deviations and Root Cause Analysis
Training – Conduct training and presentations when the need arises
Documentation Management
Audits
Standard Operating Procedures ( Maintain, review & Update)
Product Quality Reviews
Stability – Coordinate, maintain stability program and compile, review and maintain related register, logs and reports
General and also support role to RA Department

*** Comprehensive JD to be shared with short-listed candidates who meet with all the above requirements