Quality Control Laboratory Manager

Group manager for a biology laboratory in a successful biotechnology company

The QC Manager is responsible for the delivery of analytical results on time.

All documented results are in compliance with GMP, Regulatory and customer requirements. The QC manager is responsible for the QC staff and the safety, health and environment of the laboratories. All equipment and facilities used must be qualified and maintained.

Full compliance of all QC laboratories (staff training, facilities, equipment and methods)

Analytical results are performed, approved, reviewed and delivered on time. The delivery and sales plans of all batches to be analysed are translated into operational QC plans for the respective samples.

That overall business plan and objectives are translated into QC targets and plans.

Continuous improvement using Lean and Six Sigma , facilitate the Lean culture and drive towards operational excellence.

Ensure that QC is a safe and stimulating workplace

Represent QC at inspections, visits ad presentations as well as in dialogue with customers.

Communicate QC status at predetermined intervals.

Write weekly/monthly/quarterly status reports based on QC KPI's and results.

Requisitions :

• Masters, Engineer degree, or above, with pharmaceutical analysis, pharmacy, analytical

chemistry, microbiology or related majors;

• Knowledge and experience in immunological, molecular biology and cell-based test

methods and with pharmacopeial (EP, USP) and regulatory requirements for these

methods, knowledge and experience in development and validation of these test methods;

• At least 5 years experience in the similar field of pharmaceutical laboratory;

• Experience in GMP guidelines;

• Familiar with electronic systems such as Oracle and LIMS

• English: spoken and written

• Good communicator and experienced leadership skills with focus on team-spirit,staff

performance and operational excellence. Structured and energetic. A "doer" and good

troubleshooter.

• Experience in Lean and Six Sigma as a tool for continuous improvement.