The Technician, R&D Third Party Quality supports the quality oversight in the frame clinical manufacturing contracted to CMOs. This oversight is necessary to release clinical batches with respect to cGMP/GDP within timelines, to ensure enrolled patients are vaccinated to the committed date.

JOB DESCRIPTION:

• Support projects linked to Team objectives;


• Ensure review and approval of labels and associated templates used for clinical packaging, in line with internal quality standards and applicable regulations;


• Check double-blind characteristics for products used in clinical studies;


• Review pre-production documentation (printed variable data, bill of material) submitted for approval by CMO;


• Coordinate with business partner upon reception of batch records related to outsourced; manufacturing, and review GMP documentation of clinical batches labelled and packed by CMO;


• Communicate to CMO comments related to batch records;


• Capture, follow up and review quality incidents investigated by CMO;


• Follow-up CAPA committed by CMOs;


• Perform archiving of GMP documents;


• Support monitoring of team performance and KPI reporting.

PROFILE:

• Bachelor degree in sciences (biochemistry, agronomy, biology, chemistry);


• 2 years of experience in a Quality Assurance environment; ideally in the pharma industry;


• Knowledge of cGMP, GDP, cold chain, manufacturing operations, clinical trial, product; development and regulatory requirements;


• Able to communicate with diplomacy and assertiveness;


• Fluent in French and in English.

WHAT WE OFFER:

At Keyrus, thanks to the expertise of our people and external partners, each employee is welcomed with a varied integration program. You will join a dynamic and international environment with enthusiastic and professional colleagues.

We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…) based on your background and experience.

WHO WE ARE:

Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.

At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better.

From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.