The Quality Validation Engineer II is responsible to perform the quality oversight of validation activities including process, product, cleaning, equipment, material, shipping, IT and computerized systems validation at the Lessines facility.
She/He will have authority to make decisions in her/his projects, and if needed is supported by a Quality Validation Senior Engineer or Quality Validation Lead.
She/He will mainly :
- Review/approve validation documentation from projects (RA, DQ, IQ, OQ, PQ, PPQ) and associated specification documents (URS, Functional/ Design Specification) with a priority to complex projects.
- Coach of Quality Validation Engineers I, or external contributors review of documents prepared by Quality Validation Engineers I or external contributors
- Review periodic evaluation maintaining the accurate validation state of processes, facilities and systems ensuring compliance to procedures and regulatory requirements
- Provide quality guidance for the development strategy and risk analysis related to the validation
- Provide support in quality-related issues, including GMP regulations, compliance with internal SOPs, and all aspects of safe, reliable and consistent operation of the system with the support of a Quality Validation Senior or the Quality Validation Lead, if needed.
The main skills needed for this function are :
Knowledge of regulations related to validation activities in pharmaceutical industry
Exposure and/or knowledge of Validation and Engineering functions.
Experience about Quality pillars (QA, QC, Systems and Compliance) including cGMP regulations.
Strong oral and written communication skills with teams, peers, global partners
Teamwork skills. Develop and maintain good working relationships with customer groups and support an positive environment of teamwork and collaboration
Critical thinking and demonstrated problem solving skills.
Good Organizational skills