Overview
QA CSV for Production, Engineering and maintenance Equipments/Systems and support to the CDMO organization to ensure the Quality of the area of CSV activities.
Responsibilities
1. Responsible for the QA CSV for Production, Engineering and maintenance Equipments/Systems and support to the CDMO organization to ensure the Quality of the area of CSV activities.
2.Develop, promote, manage and maintain the QMS according to Mithra policies, GMPs and any other applicable regulations, clients and patients requirements.
3.Manages the QA CSV projects for Production, Engineering and maintenance. Ensures team spirit and a climate of collaboration and trust within the Qualif, Val, CSV departments and throught the all organization.
In addition to QA CSV, manage and support other QA activities of the QA qualification, compliance and systems department (flexible and polyvalent behaviors)
4.Act as SME :
1. to ensure inspection preparation and readiness to participate in regulatory inspections and compliance auditsBe flexible during external audit/ inspection to be available and present on site
5.Harmonize and optimize if appropriate document management structure and suggest improvement if any (Strategy, POL, SOP and templates). Support the creation of standardized document and facilitate the collaboration between departments.
6.Communicate regularly on the development of activities in his field of competence.
7.Ensure a regulatory check on the standards applying to qualification, validation, CSV.
8.Based on priorities, participate and support Strategic projets at Mithra CDMO. Support and give his expertise regarding projects.
9.Actively participate in continuous improvement of site activities.
Challenge proposed solutions to bring simplification and efficiency while staying compliant with internal QMS, GMP and any other applicable standards.
10.Participate in internal audit program and CAPA follow-up. Respect timing and planning of audit, report and follow-up efficiencies
11.Take ownership of quality events (deviation, CAPA, change control …) to get them closed on time and in a right quality level:
2. Support or lead investigation and assessment, propose pragmatic solutions, give direction to take appropriate decision and actions
3. Approve them
Escalate quality risks to higher management
Qualifications
4. Minimum 5 years QA experience in a pharmaceutical company (aseptic production of pharmaceutical products)
5. Master's degree with scientific orientation and relevant experience.
6. Knowledge of Good Manufacturing Practices and other pharmaceutical guidelines (21 CFR Part 11, Annex11).
7. Fluency in French and English (spoken and written).
8. Expertise in validation of computerized (LIMS, eQMS, Version Dog, etc.) /automated (SCADA, PLC, HMI) systems.
9. Knowledge of production and laboratory equipment qualification is an asset.
10. Proactive, organized, rigorous, team player and solution-oriented.
Options