Release & Stability Analyst QC

GMP, Release and Stability, QC, LEAN,

Job

CLS Services is a leading professional recruitment agency specialised in chemistry & life sciences.
For our client Janssen Biologics B.V. we are searching for a Release & Stability Analyst QC.

Keywords
  • Lab experience
  • GMP
  • Experience in Release and Stability
  • QC
  • LEAN


All test laboratories are supported by the Release & Stability team. The Release & Stability team leads and supports complex non-conformances investigations, initiates improvements to optimise the testing strategy and execution, and owns the Life Cycle Management activities for the commercial products tested at Leiden QC.
Currently the Release & Stability team consists of 15 persons and due to expansion of work load, they are looking for new employees.
Responsibilities:
  • Fully own end-to-end product testing process within Leiden QC with some support;
  • Co-ordinate the release of raw materials, drug substance and drug products from internal and external stakeholders (CMOs) to ensure on-time delivery of results per agreed timelines;
  • Co-ordinate the stability testing of large molecule products according to local procedures and agreed timelines;
  • Act as a Subject Matter Expert on release and stability processes and have a leading role during GMP inspections;
  • Participate in meetings of the quality network organisation and partner with customers (e.g. CMOs, JSC manufacturing sites, PQM) to ensure flawless experience;
  • Responsible to co-ordinate all data requests provided by various stakeholders (e.g. RA; Health Authority; DPDS) and have the accountability to plan, organise, prioritise and execute the data requests based on the stakeholder requests;
  • Responsible for reviewing the CPV plans and matrixes and update the QC release trend limits accordingly;
  • Provide input for the YBPR and APR requests;
  • Lead and drive continuous improvement projects;
  • Adhere to compliance best practices, EHSS regulations and lean principles.

Profile

The ideal candidate has a B.Sc. with 2-4 years of relevant work experience (QC in a GMP environment). You have excellent interpersonal skills as you need to communicate with different stakeholders, including internal and external customers. You have advanced knowledge of lab systems and lab environment, data integrity and data management and you have knowledge of statistical data analysis. Furthermore, you are able to train others and you have LEAN/BE experience.

Benefits

Project for at least 1 year
Salary: >3300
Days of leave: 36
See here our other employment terms for this vacancy

Company profile

Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.

They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.

Contact

Interested? Send us a detailed curriculum vitae, accompanied by an application letter indicating your motivation. Please use our online application form. (See URL) (Vacancy number A2300075)
Location Leiden
Share
Release & Stability Analyst QC

Create a job alert

Would you like to receive the latest vacancies in your e-mail box? Create a job alert based on your keyword(s) and preferences.

Sign up

Search jobs

Find your next job in Life Sciences via BCF Career. Click on search jobs to find the vacancies that fit you. 

Learn & grow

Find the training programmes and courses that help you grow in your career.

Find employers

Find your next employer by exploring the company profiles of employers in Life Sciences.

Expand your network

Grow your network with the online and live networking opportunities of BCF Career.

Post your CV for recruiters

Hyphen Projects uses cookies to remember certain preferences and align interests.
By continuing to use this site, you consent to our use of cookies.