Consultant Qualification/Validation H/F
Offer details
Wanted profile
And what about you?
- Technical diploma (engineering, chemistry, computing, physics, mathematics) ;
- Minimum of 10 years' experience in pharmaceutical drug manufacturing - Validation of equipment and processes;
- Fluent written and spoken English (at least B2) ;
- In-depth knowledge of GMP ;
- Knowledge of the main test instrument suites (e.g. GE Kaye Validator, thermal validation study data loggers, HVAC test instruments, calibration instruments);
- Integrity, strong analytical skills and attention to detail.
Are you ready to take on new challenges and start a new adventure? Don't hesitate to contact us!
Context
At Anywr.Life - brand of the ANYWR group, we specialise in the manufacture of Life Sciences We work closely with our customers in the pharmaceutical, biotechnology and medical device sectors.
As part of our expansion, we are currently recruiting a Pharmaceutical Qualification/Validation Consultant for assignments in France in the pharmaceutical industry.
Mission
Your main task will be to provide technical and management solutions for our customers in the pharmaceutical industry to improve the performance and quality of their environment.
You will work directly on our partners' sites in a GMP environment, in project mode.
Your role as a Qualification / Validation consultant will be to contribute to our customers' projects such as :
- Development of qualification plans, user/technical requirements specifications, design qualification reports, test plans, requirements test traceability matrices, qualification summary reports;
- Drawing up installation, operating and performance qualification protocols for equipment and utilities (e.g. HVAC, water systems, process gases), in accordance with internationally recognised guidelines (e.g. ISPE, GAMP);
- Drafting of thermal validation study protocols; Development of project validation master plans for the implementation of new sites, including detailed Gantt charts with predecessors and assessment of resource workload (advanced knowledge of Microsoft Project required);
- The development of a risk-based assessment at process, component and functional level using internationally recognised methodologies (e.g. FMEA, HACCP);
- Drawing up calibration and maintenance plans and associated instructions.
