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Scientist Quality Control – Capital Region, Denmark

Website Adecco Adecco

Adecco

Scientist Quality Control – Capital Region, Denmark.You will be responsible scientist for clean room environment and microbiological analyses in the department, where evaluation of results

The Department

The QC department consists of: QC Bioassay, QC Chemistry, QC Microbiology, QC Raw Materials and QC Stability.

QC are responsible for supporting production of new biopharmaceuticals by controlling raw materials, performing analytical testing, planning and executing stability programs and validating various analytical methods according to ICH guidelines from clinical phase I to phase III and commercial.

The vacant position is as scientist in QC Microbiology department (consisting of 10 highly dedicated technicians, 6 skilled scientists and one manager).

QC Microbiology is responsible for environmental monitoring (EM) in clean rooms, chemical/microbiological analyses on pharmaceutical water and TOC analysis on rinse samples from production further microbiological analysis on batches for clinical and commercial samples and method validation.

Scientist Quality Control – Capital Region, Denmark

The department works in close collaboration with Manufacturing, QA, Up- and Downstream Development, Analytical Development and external laboratories to maintain control of all steps in the manufacturing processes. Everything we do, we do in close collaboration with our customers

Within this broad working area, many different customers’ projects and with various biopharmaceuticals the QC department differs from traditional QC labs. The position requires an engaged, ambitious scientist with interest in environmental monitoring, regulations, knowledge of Microbiology and GMP biopharmaceuticals production.

Tasks & Responsibilities

The position requires expertise within clean room environment and preferable also microbiological analyses.
You will be responsible scientist for clean room environment and microbiological analyses in the department, where evaluation of results

and generation of project related GMP documentation will be a natural part of your daily work. Gathering data for reports, writing deviations and constantly optimize procedure (SOP’s, TEQ’s ect.) ensure continuous compliance with cGMP with a LEAN mindset.

A part of the job will be to give input to customer project teams, preparing for method validation (e.g. bioburden validation for clinical phase I/II through full validation) and commercial licensing.
Through internal and external audits you can expect to build great expertise within these areas by interacting with our many different international customers.

 Scientist Quality Control. Your Profile

The ideal candidate holds a MSc or PhD degree in Pharmacy, Microbiology or other relevant field and has most likely knowledge in several of the following qualities:

  • Solid knowledge on environmental monitoring and qualification of clean rooms
  • Scientist Quality Control. Experience in pharmaceutical water testing both chemical and microbiological analyses
  • Solid microbiological understanding and knowledge
  • Validation/qualification of microbiological methods and equipment
  • Scientist Quality Control. Experience with writing validation protocol, validation report, SOPs.
  • Regulatory inspections e.g. DMA, FDA and customer audits (internal and external audits).
  • General knowledge about regulatory requirement for classified production areas as well for microbiological analyses
  • Commercial GMP production and/or with production for late stage clinical trials
  • Scientist Quality Control. Production of biotechnological products and APIs
  • You like to share your knowledge and communicate openly and professionally both internally and with external customers
  • You take responsibility for your personal assignment and thrive at reaching them in a timely manner
  • You enjoy working in a high pace and be challenged in a busy business.
  • Scientist Quality Control. You are a team player combined with the ability and desire to work independently
  • Excellent communication, presentation and interpersonal skills
  • Ability to apply organizational skills to systems and efficiency improvement

Scientist Quality Control
The organization has international customers and our company language is English. It is therefore vital to be fluent in written and spoken English.

 Scientist Quality Control. Application

We cooperate with Adecco on recruitments. Accordingly Adecco will be responsible for the recruitment process. For more information about the position, please contact Adecco’s recruitment team:Line Sophie Heyn +45 5185 7005

We continuously evaluate incoming applications and conduct interviews accordingly.

Seniority Level

Mid-Senior level

Industry

  • Alternative Medicine
  • Biotechnology
  • Pharmaceuticals

Employment Type

Full-time

Job Functions

Scientist Quality Control – Capital Region, Denmark

To apply for this job please visit www.linkedin.com.

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