BrightOwl Loader Loading

Qualification Specialist - Biotech Job Netherlands,  


Posted on : 10 April 2017

Project Description

Qualification Specialist - Biotech-QUA005072DescriptionFor our Biotech Quality organization in Oss we are currently hiring a:Qualification Specialist - BiotechAbout MSDMSD 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.MSD. Be well. For more information, visit our website: www.werkenbijmsd.nlThe organizationQuality 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.https://youtu.be/xzi2TewWJIEThe PositionReporting 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.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 workOur 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.InformationFor more information about the position, please contact Peter Gloudemans, Quality Assurance Lead by phone via: 0412  661398 or 0621527737.ApplicationIf you are interested in this challenging role, you are invited to apply online by uploading your resume and application letter in English.Recruitment Agency / Search Firm representatives please note:MSD will not accept unsolicited CVs from recruitment agencies / search firms under any circumstances. In order to present CVs to MSD, your Recruitment Agency / Search Firm will have been invited to work on a specific vacancy and have Terms of Business signed and agreed with the relevant Recruitment and Staffing Regional Lead. Should you send CVs for a vacancy that you have not been specifically invited to work on to any employee at MSD (via email, post, internet, Taleo or any other method), these will be deemed the sole property of MSD. MSD will pay no introduction fee to the Recruitment Agency / Search Firm if a candidate is hired as a result of an agency introduction under these circumstances.Job: Quality Operations Job Title:Spclst, QualityPrimary Location: EMEA-Netherlands-NB-OssEmployee Status: RegularNumber of Openings: 1Company Trade Name:MSD Job Segment: Biotech, Microbiology, Engineer, Quality Assurance, Change Management, Science, Engineering, Technology, Management

Locations

Oss NL

Find a Job Find Candidates

Most Recent Searches

Most Famous Searches

You might also like