QA Specialist

A world leading pharmaceutical company is looking for QA Specialist to join their extraordinary team and help them make healthcare safer for everyone.

Job Responsibilities

• 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

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

#LI-CY1