Quality Assurance - GMP Specialist Belgium,
Keyrus Biopharma (company)
role and responsibilities:
- quality review of executed batch records for Drug substance and drug product for Clinical Trial supplies.
- release of raw materials used in production of Drug substance and drug product for Clinical trials.
- quality review of Analytical methods and analytical Validation protocols and reports for Drug substance and drug product in development.
- quality review of Analytical methods transfer protocols and reports for Drug substance and drug product in development.
- quality review of stability protocols and reports for Drug substance and drug product in development.
- writing Quality Assurance agreement between Contract manufacturing organization and the client's quality department.
- a good understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the Product Development context is essential.
- qa/Compliance experience in imp manufacturing, facility operation, Laboratory Compliance and Quality Systems.
- areas of expertise should include Compliance, Quality Assurance, Quality Control, Validation, technical services.
- in-depth knowledge of at least one scientific discipline related to Pharmaceutical Sciences.
- fluent in French.
- good written Communication in 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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