Job Description

As a Development QA Governance - Laboratory System Specialist within Keyrus Biopharma, you will join a team on client's site to be the main Quality Assurance contact and provide support for resuming activities of GMP Development Laboratories in a foreign subsidiary and the transfer and subsequent requalification of their equipment to another site.

Responsibilities:

Ensure appropriate activities are taking place:
Risk assessments
Laboratory and equipment decommissioning
Documentation archiving
Quality Management Systems update
Provide oversight for their execution
Identify, mitigate and subsequently resolve compliance and quality issues that may affect the client's development activities and products
Ensure appropriate communication on the project progress and potential quality risks with Quality Governance laboratory expert and the head of the team

Profile

Experience & Required skills:

Minimum 4 years of experience in a GMP environment regulated environment
Knowledgeable about laboratory Quality Management Systems in GMP environment
Knowledgeable in Biological Analytical Development is a plus
Autonomous, pragmatic, well organized
Fluent in French and English

What we offer

You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…). Each employee will be welcomed with a varied integration program. We invest considerable time and resources in training our staff (technical and non-technical courses). You will join a dynamic and international environment with enthusiastic and professional colleagues.

Who we are

Keyrus Biopharma 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 Biopharma 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.

Keyrus Belgium Offices:

Office Park Waterloo - Drève Richelle 161 - 1410 Waterloo
Nijverheidslaan 3, - Strombeeck Bever

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