Commissioning & Qualification Consultant Life Sciences / GMP
Pratteln, Switzerland
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
READY TO APPLY?
Completely convinced after reading this job posting? Let’s get together! Start your application here or get in touch with our recruiter. We would love to schedule a first meeting with you!
WHAT TO EXPECT WHEN YOU APPLY?
Application
Your journey begins with your application, which we’ll attentively review and respond to with valuable feedback.
Video call
Once you meet the position’s basic qualifications, our recruiter will connect with you to schedule a video call.
Face-to-face interview
Delve deeper into the role and responsibilities during a face-to-face interview with the hiring manager, who will share insights into your prospective position.
Technical interview
Engage with potential team members, showcasing your skills and assessing if the role is the ideal match for you.
Job offer
Congratulations, we believe you’re the perfect fit for the job!
Contract
Signed & sealed! We’re thrilled to welcome you aboard our team.
