About Akkodis
Akkodis, is a global leader in the engineering and R&D market that is leveraging the power of connected data to accelerate innovation and digital transformation. With a shared passion for technology and talent, 50,000 engineers and digital experts deliver deep cross-sector expertise in 30 countries across North America, EMEA and APAC. Akkodis offers broad industry experience, and strong know-how in key technology sectors such as mobility, software & technology services, robotics, testing, simulations, data security, AI & data analytics. The combined IT and engineering expertise brings a unique end-to-end solution offering, with four service lines – Consulting, Solutions, Talents and Academy – to support clients in rethinking their product development and business processes, improve productivity, minimize time to market and shape a smarter and more sustainable tomorrow.
Akkodis is part of the Adecco Group. Our Webstite : www.akkodis.com
Key responsibilities
* Apply and maintain the Pharmaceutical Quality System (PQS) per GMP/GDP and applicable regulations.
* Review and approve GMP documentation (SOPs, work instructions, protocols, reports, batch records).
* Manage deviations, CAPAs and change controls: assessment, investigation support, follow-up and closure.
* Support qualification / validation review and approval.
* Contribute to risk assessments and to the Contamination Control Strategy.
* Manage supplier and material quality (qualification, complaints, quality agreements support).
* Support computerized system validation (CSV): GxP system classification, validation deliverables (URS, IQ/OQ/PQ), periodic review, audit trail and access reviews.
* Ensure data integrity (ALCOA+) and compliance with Annex 11 / 21 CFR Part 11 across computerized systems.
* Support customer audits and regulatory inspections (preparation, hosting, follow-up).
* Track quality KPIs and escalate quality issues to management.
Required profile
* Diploma in pharmacy, chemistry, biology, bio-medical sciences or related field.
* 5+ years of experience in QA in the pharmaceutical industry, ideally sterile manufacturing.
* Strong knowledge of EU GMP (Annex 1), GDP and data integrity (ALCOA+) expectations.
* Hands-on experience with deviation, CAPA and change control management.
* Computerized System Validation (CSV) competencies: GAMP 5, Annex 11, 21 CFR Part 11, validation lifecycle (URS, IQ/OQ/PQ).
* Experience supporting audits and regulatory inspections.
* Experience with an eQMS system (e.g. Scilife or similar).
* Rigorous, structured, and able to work autonomously with cross-functional teams.