Quality Control Assistant Permanent Contract (M/F)

Under the responsibility of the Quality Control Team Leader, you will ensure the compliance of studies and deliverables by respecting established processes and client specifications, within the specified deadlines.

Your main missions:

Audit of deliverables related to client studies:

• perform the Quality audit of study files and associated deliverables, according to defined methods and within the specified deadlines, and attest to their compliance.
• Identify and formalize non-conformities, proceed with their analysis and the definition of curative/corrective actions, in collaboration with the involved departments, in relation to the Quality facilitators and/or the Team Leader.

Ensure the adequacy of the methods and records used, initiate and proceed with documentary updates.

Archiving

• Carry out archiving campaigns for physical and electronic client study files according to the defined periodicity and method, update and ensure the maintenance of the archive database.
• Perform physical archiving of test production files and semi-finished product production/qualification files as well as any other transmitted Quality documents.
• Organize and implement the outsourcing of Quality department archives in relation with the service provider.
• Manage requests for the release of documents, archived on-site or outsourced, as well as returns, while ensuring their traceability.
• Proceed with the unarchiving of study files, production files, and Quality documents at the end of the period.
• Ensure the adequacy of the methods and records used, proceed with necessary documentary updates.

Quality

• Update and distribution of site Quality indicators.
• Participation in documentary management activities in collaboration with the Quality Facilitator in charge of this activity.
• Participation in various Quality missions in connection with the company's Quality policy.

Qualifications Training: Bac +2/4 Quality with scientific knowledge (Biochemistry, Biology) Experience: Experience in study auditing desired Technical skills: Analytical capacity, curiosity, detail-oriented, sensitive to quality and client deadlines, knowledge of basic quality tools Languages: operational English Soft skills: motivation, reactivity, diplomacy, rigor

Additional information Driven by strong values (Team spirit, Respect for people and the environment, Integrity, Innovation, Dynamism and Quality), the company and its employees move forward and write the company's history together in a spirit of trust and mutual commitment.

Ideal start date: as soon as possible Work in administrative hours Collective agreement: Industrie Pharmaceutique (3104) Permanent contract (CDI)

Remuneration elements: Monthly salary of €2,193.07 gross (minimum conventionnel 4A) Profit-sharing and Participation according to company performance Mandatory company health insurance (90% company coverage) + optional Meal voucher with a nominal value of €12 (60% company coverage)

Hours: Individualized hours based on administrative hours Teleworking agreement base of 37 weekly hours with RTT