MAIN ACTIVITIES FOR THE JOB

Support implementation of PV process in PV operational Teams
Ensure that SOP are up to date and regularly reviewed for improvement, following a risk based approach and performance improvement objectives
Ensure that SOP are user friendly and based on visual and graphics (Business process modeling methodology)
Support continuous improvement to meet compliance goal and company objectives
Manage non conformance and ensure implementation on time of CAPA plans
Be the client point of contact for Quality topics when dedicated to a project
Have oversight on PV NC and CAPA plans, ensure consistency of data, provide reports, support Quality KPI trends analysis and ensure set up of remediation plan when needed
Train the PV Team to Quality process and use of eQMS
Support client audits, from team preparation, document preparation, meeting hosting and facilitating, preparation of audit response report
Act as lead auditor for internal / vendor audit

Experience Details:

8 + years’ experience within a Quality role in Pharmaceutical industry + previous role or knowledge in PV domain

Management of client specific procedures, NC and CAPA for client
Trainer of OPS staff on Quality process (e.g. NC/CAPA)
Writing of procedure, process mapping, gap analysis
Support of GVP audits
Ability to lead working group with clients, take minutes on flight, propose solution
Client facing to defend PLG process and find compromises

PV training
Quality assurance specific training
Experience in using QMS tools (such as ENNOV, Trackwise, Mastercontrol, Veeva etc)
knowledge of methodologies such as ISO 9001 2015 standard, Six Sigma, Lean or CMM
Graphical process modeling methods and tools (Visio)
Skill in MS Office tools, Excel, SharePoint, Content Management tools

Bachelor’s or higher graduate degree in a science related field, or equivalent experience

French + English (Native/Full Proficiency)