The candidate will respond to the Quality function and will collaborate with technical Services to ensure that equipment validation and calibration activities meets cGMP and Corporate Standards over the life cycle. S/he will ensure that any planned changes to the facilities, equipment and utilities, which may affect the quality of the product, is formally documented and the impact on the validated status or control strategy is assessed.
Promoting proper and proactive business partnership with Technical Services is a key part of the role and the candidate will rapidly gain exposure to critical projects for the site, and interaction with external actors such as regulatory agencies and clients.
- Support Technical Services Group to ensure that Decisions on the scope and extent of qualification are based on a justified rationales and risk assessments Ensure that activities are planned and executed according to business priorities, production planning and client needs.
- Ensure that qualification and calibration activities are only performed by suitably trained personnel who follow approved procedures and apply good documentation practices, ensuring the integrity of all data.
- Ensure that change control and deviation management for qualification and calibration is performed according to cGMP and Corporate Standards;
- Support the other departments to ensure that the specification for equipment, facilities, utilities or systems are defined in a URS and/or a functional specification
- As needed, participate to Factory acceptance testing /Site acceptance testing/ Design Qualification/ Installation Qualification/ Operational Qualification /Performance Qualification activities
- At least 5 years of experience with GMPs and Equipment Qualification
- Experience with production and quality risk management processes
- Good level of english
- Leaderhip and change management skills
- Pragmatic and goal oriented approach