04 67 20 77 30
Poste
Sensorion is recruiting a Quality Assurance Manager F/M on a permanent basis contract (CDI) based in Paris or Montpellier.
The Quality Assurance Manager supports the implementation of Sensorion quality management system to guarantee the company compliance with applicable requirements (i.e.: internal procedures, applicable regulations and standards).
Main Activities
Quality Management System
- Support for the management of critical outsourcing, in particular this involving clinical projects-related activities. This shall include:
- Qualification of subcontractors,
- Management of quality subcontractors’ monitoring (e.g., collection / maintenance of quality-related documents, transmission / collection / analysis of annual questionnaires, organization of external audits), and
- Follow-up of quality events (i.e., OOS, nonconformance, deviations, complaints, change controls) with subcontractors and internal teams;
- Quality documentation management :
- Implementation / update of quality documents;
- Management of the adequate distribution, traceability, storage and archiving of quality documents;
- Management and maintenance of the quality documentation registry
- Management of quality documentation awareness related activities (e.g., “read & understood” and/or training follow-up).
- Support for the implementation of monitoring tools and analysis of the QMS processes performance;
- Interface between QA and operations (e.g., via quality management representatives).
Audit
Support the assessment of the QMS effectiveness through the establishment and implementation of internal and external audit programs:
- Plan, execute and/or support internal and external audits;
- Participate in audits and inspections;
- Maintain the audit program.
Information / Advice / Training
- Conduct of quality and normative watch (e.g., on GLP, GMP, GCP, GLP, ICH Quality series, GDPR), associated impact analyses and support the implementation of action plans applicable to Sensorion activities, in particular with regards to GCP and GDPR.
- Support and/drive awareness and training of Sensorion teams on requirements applicable to the Sensorion QMS.
Profil
- Education: Life Sciences, Biomedical Sciences, Pharmacy, Engineering / Biotechnology, Quality Assurance or equivalent.
- Professional experience: 3+ years.
- Strong knowledge of quality management systems and quality standards (e.g., ICH, GLP, GMP, GCP, ISO 9001 et/ou ISO 13485, ICH Q5s-Q7-Q8-Q9-Q10-Q12, GDPR, ISO 14001);
- Knowledge of quality management, problem solving and project management tools, as well as strategic planning and cross functional execution;
- Language:
- French: Excellent expression (written, read and spoken).
- English: Excellent expression (written, read and spoken).
- Strong level of involvement and very good team spirit.
- Rigor, autonomy, responsiveness, and adaptability;
- Respect for confidentiality.
_____________________________________________________________________
CAUTION!
Several incidents involving organizations and individuals claiming to be fraudulently recruiting on behalf of Sensorion have recently been identified.
The objective of the fraudsters is to extort money from applicants by requesting additional expenses (medical devices, travel agency, visa fees, etc.) or obtaining personal data (bank details, address, etc.). Please note that Sensorion, its subsidiaries or the recruitment firms they appoint during the hiring process do not request financial contributions or bank details from candidates under any circumstances.
We take this situation very seriously and are taking all possible actions to identify and put an end to this type of fraud.
We recommend the following good practices:
do not make any payment for any reason;
do not respond to unsolicited job offers or job offers of which you think the origin is suspicious;
apply only via the contact form below;
Never communicate personal or financial information to strangers.
Postuler