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Biotech Quality Specialist Job Vacancy @ Merck Oss Netherland

Biotech Quality Specialist Job Vacancy @ Merck Oss Netherland

Biotech Quality Specialist Job Vacancy @ Merck Oss Netherland: MSD 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. Biotech Quality Specialist Job Vacancy @ Merck Oss Netherland

Biotech Quality Specialist Job Vacancy @ Merck Oss Netherland

Qualification Specialist – Biotech Job

Date: Apr 18, 2017
Location: Oss, NL

Qualification Specialist – Biotech-QUA005072

Biotech Quality Specialist Job Vacancy @ Merck Oss Netherland

Description

For our Biotech Quality organization in Oss we are currently hiring a:

Qualification Specialist – Biotech

MSD. Be well. For more information, visit our website: www.werkenbijmsd.nl

The organization
Quality Operations Biotech (around 60 people) is responsible for ensuring that our Manufacturing Division Oss 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 Oss as well as regularly interact with other Manufacturing Division sites.

For more information about MSD Biotech, please watch the MSD Biotech Oss video below.

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.

As part of the role the Qualification Specialist will be responsible for:

Projects

  • 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).

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 masterplans 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).

Advice

  • Advicing the departments and ensure implementation of the qualification strategy.

Deviations

  • 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.

General

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

Biotech Quality Specialist Job Vacancy @ Merck Oss Netherland

Qualifications

*
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.

Information

For more information about the position, please contact Peter Gloudemans, Quality Assurance Lead by phone via: 0412 – 661398 or 0621527737.

Application

If you are interested in this challenging role, you are invited to apply online by uploading your resume and application letter in English.

Job: Quality Operations Job Title:Spclst, Quality

Primary Location: EMEA-Netherlands-NB-Oss

Employee Status: Regular

Number of Openings: 1

Company Trade Name:MSD

Job Segment: Biotech, Microbiology, Engineer, Change Management, R&D Engineer, Science, Engineering, Management

Biotech Quality Specialist Job Vacancy @ Merck Oss Netherland

To Apply & View Original Notification: https://jobs.msd.com/msd/job/Oss-Qualification-Specialist-Biotech-Job-NB/366356200/?source=biochemadda

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