NonStop Consulting
- Location:
- Maastricht – Limburg, Nederland, Netherlands
- Salary:
- market rate
- Type:
- Contract
- Start Date:
- ASAP
- Contract Period:
- 12 months
- Main Industry:
- Search Science Jobs
- Other Industries & Skills:
- Health, Nursing & Social Services Scientific Labatory Work, Research & Development
- Advertiser:
- NonStop Consulting
- Job ID:
- 127164541
- Posted On:
- 17 May 2023
Quality Control Expert – Contract
Our client is seeking a Quality Control Expert to join them, a multinational leader in life sciences operating globally as a world-class Drug Substance and Drug Product life cycle developer and manufacturer, in the Quality Control Department!
This is a one-year contract position in which you will be implementing and executing activities in the Quality Control department while ensuring compliance with all existing GMP and safety standards.
Combining your technological insight with scientific expertise, you will help deliver new and innovative medicines that treat a wide range of diseases.
Responsibilities:
* Participate in the initial assessment of new methods to be transferred to QC.
* Generate, review and approve QC documents and act as an expert for QC during internal and external audits and inspections.
* Act as a QC Department representative for Analytical Method Validation topics and collaborate with Analytical Development (R&D) during team meetings, quality councils and client meetings as required.
* Lead and participate in method validation planning (including the protocol, data review, statistical analysis, report preparation and review), platform method validation strategy implementation and assessment for future projects.
* Act as an SME for method-specific devices (initiation/review of URS, PQ and define maintenance requirements.
* Provide input for problem-solving issues within your branch.
Requirements:
* M.Sc./Ph.D. in Biochemistry, Biotechnology, Life Sciences, Pharmaceutical Chemistry or a related discipline.
* 5+ years in Biologics Quality Control / Analytical Development
* In-depth understanding of Quality Control Analysis: HPLC, Capillary Electrophoresis, RT-PCR, UV Spectrophotometer, Gas Chromatography, ELISA, and safety tests.
* Good knowledge and experience in analytical methods, equipment and good practices for Biological Products.
* Knowledge about ICH guidelines and other regulatory agencies is desirable.
* Global Audit experience is desirable.
If this role sounds like something you would be interested in, Apply, ideally in Word format, via this site.
If this role is not quite right for you but you would like to have a conversation about other roles, please search and connect with me, Tyler Magalhaes, on LinkedIn.
To help us track our recruitment effort, please indicate in your email/cover letter where (vacanciesineu.com) you saw this job posting.