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Expert, Development QA (GMP, GDP)

Website Achieva Group Limited

An excellent opportunity has arisen to join a leading pharmaceutical company as a Expert, Development QA (GMP, GDP).


Manage all required activities to support the release of drug substances, drug products and intermediates for development or pre-commercialized products in portfolio sent worldwide including approval of master process documentation, batch record review, resolution of investigations, and assessment of change controls, this in close collaboration and quality oversight of CMOs

Drive all QA related topics and be the main QA liaison for partners collaboration for development activities.

Accountable for the compliance to Quality assurance standards during the design, development, manufacture, supply and control of drug substances, drug products and combination products.

Supervise the GMP/GDP Development QA group as assigned within the Quality Assurance group.

Responsible for the Quality assessment during supplier/CMO evaluation.


Advanced University degree in Pharmacy, Chemistry or alternative technical/science university degree.

At least 10 years of experience in pharmaceutical manufacturing, with at least 5 years in Quality Assurance or Quality Control.

Proven experience related to Health Authorities inspection, risk assessment and CAPA management.

Thorough knowledge of manufacturing, both at development and commercial stages, and control of drug substances, drug products and combination products.

Several years of experience in leading people in cross functional teams.

Thorough knowledge of (c)GMP/GDP and relevant international regulatory requirements as well as ability to accurately interpret and implement Quality standards

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