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Qualification Specialist - Biotech Job - Netherlands  

MSD (company)

Posted on : 10 April 2017

Project Description

About Us:
  • Our company  is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. 
  • Today, we are building a new kind of healthcare company  one that is ready to help create a healthier future for all of us. 
  • Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. 
  • To this end, we strive to create an environment of mutual respect, encouragement and teamwork. 
  • As part of our global team, you ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

The Organization
  • Quality Operations Biotech (around 60 people) is responsible for ensuring that our Manufacturing Division  manufactures, tests and releases Biological Drug Substances and Bulk Drug Products in accordance to applicable local and international regulations. 
  • To this end the various Quality departments actively collaborate and set standards for all other Integrated Process Teams (IPTs) and CoEs of Manufacturing Division as well as regularly interact with other Manufacturing Division sites.

The Position
  • Reporting into the Quality Assurance Lead the Qualification Specialist will be responsible for assuring that all assets (process equipment and IT systems) of IPT s and CoE s are qualified and up to date with the latest guidelines.
  • He/ she will act as a Subject Matter Expert for CoE Quality Biotech for investment projects.
  • The Qualification Specialist will cooperate internally with IPT-USP, IPT-DSP, Tech Ops, CoE s and GVBC. 
  • Externally he/ she wil cooperate with Global Compliance Quality and Global Engineering Services.

  •  Reviewing investment projects from Quality point of view (expert role in relation to cGMP regulations);
  •  Supporting departments in investment projects, act as a Quality Lead for CoE Quality Biotech for Quality (compliance).

  •  Ensuring the validated status of cGMP equipment/ assets/ utilities/ automation of IPT's, QC and ADV, in line with quality procedures and guidelines:
  • Reviewing validation master-plans and validation summary reports;
  • Checking within scope change- documentation;
  • Reviewing and approving all qualification documentation for new and existing equipment, including changes;
  • Determining and deciding upon quality and cGMP requirements for new equipment and qualification strategy (e.g. URS, FAT, SAT, IQ,OQ,PQ).

Advising the departments and ensure implementation of the qualification strategy.

  • Assessing all defects during qualification and ensure that all defects are solved according procedures and guidelines;
  • Assessing deviations (e.g.during manufacture) that are related to equipment or facilities.

  •  Continuous focus on quality and safety compliance;
  •  Customer focus;
  •  Go to Gemba;
  •  Making problems visible & strive for Continuous Improvement.

Bachelor s degree in Quality, Biologics, Biotechnology or related area;
  •  At least 3 years of experience in Quality Assurance, Quality Control or related technical field;
  •  Strong project management skills (e.g. Green Belt/ Black Belt certified or willing to obtain degree);
  • Broad technical competencies with past exposure to manufacturing, analytical or clinical environments;
  • Previous experience on Biologics and /or microbiology are a plus;
  • Cross-functional quality experience (e.g. batch release, change management, investigations, audits etc.);
  • Strong background in manufacturing and/ or R&D;
  • Excellent written and verbal skills in English and Dutch.

A good place to work 
  • Our employees are the key to our company s success. 
  • We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. 
  • Our Company s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.

Job Segment:  Biotech, Microbiology, Engineer, Quality Assurance, Change Management, Science, Engineering, Technology, Management                       

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