Manager Quality Control (QC) at HAL Allergy

As Manager Quality Control you manage the full spectrum of activities at QC; microbiology, biochemistry, stability, LIMS and incoming goods (+/- 25 employees). You work closely together with analytical development on the implementation of new assays in the labs. 

By ensuring alignments across multiple teams and improving communication with product delivery and QA, you ensure on time delivery of results. Additionally you work on process improvements within the department and improving oversight on all aspects of the QC activities needed for GMP manufacture and release.

 

Responsibilities

  • You approve/reject raw materials, packaging materials, intermediate- and end products.
  • You approve specifications, sampling instructions, test methods and other QC procedures.
  • By handling changes and deviations, training and updating procedures you maintain the compliance status of the department.
  • You are responsible for planning of analyses within QC, in order to guarantee efficient and well-timed test executions.
  • For Stability you are responsible for management, execution and reporting of ongoing stability studies. In collaboration with the Stability Coordinators you make sure that the set up, execution and reporting of stability studies relate to changes and regulatory demands.
  • As owner of the LIMS system, you make sure to keep the system up to date and compliant.
  • You are responsible for the total sampling process (traceability, number, documentation, warehousing).
  • Additionally, you take care of set up and maintenance of trend analyses, execution and reporting of validation of assays and advise with regard to improvement of assays and protocols.

 

Qualifications

  • Master’s Degree in Biology, Chemical or Pharmaceutical Science.
  • Extended experience with microbiological, biochemical and analytical chemical duties.
  • 5-8 years relevant working experience in a similar management position.
  • Strong GMP knowledge.

 

Personal Skills

  • You are a manager with strong people management skills, who develops, coaches and corrects personnel where needed.
  • You are able to communicate with people across different departments and at various levels of seniority.
  • You have a pro-active attitude and are able to solve problems, also when this is not part of routine-work.
  • Even though you can convince others with your ideas and plans, you are also open to take other opinions into account. 
  • With your analytical skills you are able to set priorities and to make fundamental decisions.

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