Quality Specialist

Description

We are looking for a QA specialist to actively support the manufacturing unit in all GMP aspects.

Tasks:

Ensure GMP and regulatory compliance of the manufacturing unit and its suppliers

Review and approve GMP documents and records, e.g. process and cleaning validation, changes, deviations, master batch records etc.

Execute batch disposition of Chemical Intermediate and Drug Substance batches

Support the manufacturing unit in all GMP aspects
Participate in deviation investigation cross functional teams and approve deviation records and associated actions and CAPAs

Support the preparation and follow-up inspections/audits by health authorities, customers and internal teams

Support launch products

Maintenance and adherence to cGMP and SOPs

Author/develop Modules for the Quality Manual and local SOPs

Minimum requirements:

University or academic degree in Chemistry, Biology, Pharmacy or equivalent

Advanced know-how of GMP requirements in API manufacturing

Excellent German and English both oral and written

Strong communication, negotiation and interpersonal skills

Strong problem solving, decision making and planning skills

Ability to work under time pressure

Michael Bailey International is acting as an Employment Business in relation to this vacancy.