QA Validation (H/F)

Leading French independent pharmaceutical Company specialised in ethical medicinal products. 92% of Servier’s sales are achieved internationally, with several subsidiary companies abroad. We are looking for V.I. E’s, for our subsidiary in Ireland. Description of the mission: The QA Validation VIE will report to the QA Validation Supervisor, to coordinate and monitor the validation activity on site and to ensure compliance with SII validation procedures by reviewing and/or approving validation documentation across all areas of validation at SII. Key responsibilities will include: • Coordinate, preparation, execution, and reporting of Validation projects as outlined in the Validation Master Plan schedule (Cleaning, Process, and Transport). • Preparation of Protocol and Reports. • Carry out reviews on Validation/Qualification documentation. • Support the post Validation Monitoring program to ensure the validated status is maintained. • Adhere to SOP’s, WISOP’s, Validation Master Plan and Policies detailing the company validation strategy and formal release of processes, equipment, and systems. • Contribute to achievement of the Validation Master Plan Project schedule and metric. • Adhere to the Change Management and Quality Management system procedures and metric. • Support inspections/audits, continuous improvement, root cause problem solving and risk assessment activity. Team Work: • Work co-operatively and flexibly both within your department and with other departments. • Be prepared to undertake additional tasks as requested to meet operational or business requirements. • Partake in any in-house or external training deemed necessary or enhancing for the carrying out of the role. • Partake in cross departmental working groups. • Apply all GMP, Safety & Environmental requirements. • Support the Quality and Safety initiative on site.

Educational background: Third level degree in a scientific or engineering discipline or equivalent. Field of study: Science / engineering Languages: Fluent English Experience required: 1 year or more in Pharmaceutical Industry. Computer skills: Familiarity with Microsoft Office package.