Commissioning & Qualification Consultant Life Sciences / GMP

Agidens is on the lookout for new talent! For our validation and compliance team, we are currently looking for a motivated Commissioning & Qualification Consultant.

As a C&Q Consultant within the Life Sciences team, you are responsible for the commissioning and qualification (C&Q) activities of the Technical Services department. You will use certain guidelines and procedures to do this. It’s definitely not just documentation, performing tests is also part of it. Variation guaranteed!

WHAT WILL YOU DO?

• Perform qualification/validation phases in accordance with global and local company policies and procedures as well as legal and regulatory requirements.
• Prepare/review qualification/validation plans including but not limited to DQ, IQ, OQ, PQ plans/protocols and final reports for new or modified GMP utilities, facilities and process equipment.
• Perform DQ, IQ, OQ, PQ, including protocol deviations, investigations and corrective actions for new or modified GMP utilities, facilities and process equipment.
• Plan and track the implementation of commissioning and qualification activities/documentation against the project(s) schedule.
• Preparation, review and approval of technical and GMP related documents (URS, FMEA, impact/risk assessment, master plans, qualification/validation documents)
• Coordination and execution of FAT/SAT, commissioning activities for new GMP systems in cooperation with internal and external partners
• Coordination and supervision of external suppliers

WHO ARE YOU?

Knowledge & Competencies:

• You have experience working according to specific guidelines and regulations (e.g. GMP, GLP).
• At least 3 years of work experience in a pharmaceutical company in a C&Q/CQV equivalent position
• Bachelor's/Master's degree in technical or scientific subjects.
• You are communicative and can adapt to different social situations.
• You are able to work with precision and enjoy working independently.
• You have good communication skills (both oral and written) in German and English.
• Knowledge of commissioning and qualification requirements according to cGMP regulations and international guidelines (Eudralex, WHO, CFR FDA, ISO)
• Experience working with ISPE Baseline Guide Vol. 3, Vol. 4 and Vol. 5 is a plus
• A professional appearance, a high degree of independence and organisational skills

WHAT DO WE OFFER?

• Exciting and varied tasks in the environment of the life science industry
• Development opportunities in an internationally growing company
• A dynamic team that attaches great importance to a collegial and open atmosphere
• Attractive employment conditions with an excellent occupational pension fund
• 1st class accident insurance (private)
• Additional benefits such as daily meal allowances
• Academy days and team building events
• International onboarding
• Flexible working hours, 5/6 weeks holiday
• Homeoffice - the possibility of working from home

READY TO APPLY?