Quality Assurance (QA to oversee compliance of 3rd party production manufacturers). Midrand. R8[...]

Specialist Search Recruitment • Other • Midrand, KwaZulu-Natal, Gauteng, South Africa • $200 - $300 / year • 13h ago

Quality Assurance (QA) to Oversee Compliance of 3rd Party Production Manufacturers

Location: Midrand

Salary: R65k to R70k + guaranteed 13th cheque, negotiable (Total package: R800k to R900k)

The purpose of this position is to ensure cGMP compliance, and assess, authorize, and oversee all Quality Assurance initiatives of South African and overseas 3rd party and Contract manufacturers.

A strong QA background, especially in QA at a production site, is an advantage.

Key Responsibilities:

Reviewing and approving all master production and quality documentation.
Compiling and reviewing SOPs.
Participating in audits on contract manufacturers.
Managing change controls and deviations.
Handling CAPAs initiated at contract manufacturers relating to manufacturing, customer complaints, stability, OOS, and recalls.
Monitoring validation and technical transfer batches at contract manufacturers.
Conducting QA release.
Participating in projects, product launches, and product transfers.
Managing the stability schedule and process for products manufactured at contract manufacturers.
Conducting quality reviews of operations at contract manufacturing sites.

Minimum Requirements:

3 years in a pharmaceutical manufacturing environment
2-3 years quality assurance experience - preferably with 3rd party manufacturers

This role has a broad salary range, influenced by specific industry skills relevant to this position, specific relevant qualifications and courses, the number of years in the pharmaceutical sector, the number of years in a QA environment, the number of years working with 3rd party suppliers and external contract suppliers, specific software skills, and other relevant factors.

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