As an internationally active SME we are looking for a QA validation expert 80-100 % (f / m).
As an expert, you manage, organize and supervise the risk-based validation and qualification of products, equipment and test methods.
You plan periodic validation and qualification with the engineering, quality control and production departments and coordinate the timely execution.
Within the QA Industrialization and Innovation sub-department, you support the line manager in the compliant validation and qualification of processes / products and the set-
up of stability studies. You support and engage yourself in projects related to the responsibility of QA Industrialization and Innovation with the aim to improve the overall performance and position of the company on the market.
Creation, coordination and update of company-specific guidelines and master plans for the qualification and validation of technical equipment, analytical methods, production processes and stability studies
Check, revision, approval and archiving of qualification, validation and stability documents
Planning and implementation of trainings for people who create, carry out or support qualification and validation
Supervision of production and laboratory equipment qualification as well as of processes to be validated
Technical expert and contact person for the requalification of technical equipment
Elaboration of stability plans and reports
Deputy of the Head QA Innovation & Industrialization
University of Applied Sciences for Chemistry and / or Biochemistry with
At least 5 years of experience in validation and qualification of production processes and equipment in the pharmaceutical (API) and / or in vitro diagnostics industry
Experience in multi-stage risk analyses, facilities and equipment qualification, cleaning and process validation in the cGMP environment (pharma / medicine) is a prerequisite.
Knowledge and experience in the interpretation and appropriate implementation of regulatory requirements on specific topics (at least validation and qualification).
Experience in project management and working in interdisciplinary teams with good internal and external (written and oral) communication skills.
Language skills : German spoken and written, English spoken and written