A world leading pharmaceutical company is looking for QA Specialist to join their extraordinary team and help them make healthcare safer for everyone.
- Initiate, support and supervise qualifications of complex analytical equipment in close collaboration with the analytical laboratories.
- Act as a trainer for relevant qualification topics.
- First point of contact to Quality Compliance in all topics related to your field of work.
- Actively participate in global teams, projects, networks and/or platforms. Fulfill all re-
- lated tasks and responsibilities related to own discipline.
- Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s).
- Interact with authorities / inspectors where appropriate. Act as SME regarding sys- tem qualification topics.
- Interpret results, evaluate data, draw relevant conclusions and write reports.
- Interact/collaborate with other teams/functions to facilitate transfer of knowledge. 1 4. Actively contribute to team goals.
- Contribute to evaluation of new scientific technologies/equipment and prepare CAR
- and URS if applicable.
- Coach/lead team members: support objectives setting, participate in recruiting processes if applicable.
- Strategic and scientific contribution to Networks, target achievements according to network charter and annual objectives
Skills and Requirements
- Technical expert studies with PhD and 0-2 years relevant experience
- Master of Science with 4 years of relevant experience
- Bachelor of Science or equivalent technical education with 8 years relevant experience in industry or equivalent
- Fluent in English (oral and written) Basic skills in local site-language (German), as
- required for the position & Awareness of safety regulations and for safe
- handling of chemicals and equipment. Appropriate number of years of experience in an analytical GMP environment.
- Very good knowledge of qualification processes for laboratory systems in a GMP environment including software qualification (CSV) and related technical tools and software.
- Scientific project management and leadership skills
- Good knowledge on relevant regulatory guidelines and good understanding of regulatory expectations
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.