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Quality Laboratory Supervisor (Center of Excellence) - Netherlands  

MSD (company)


Posted on : 22 April 2017

Project Description

Quality Laboratory Supervisor (Center of Excellence)-QUA005160DescriptionFor our Biotech organization in Oss we are currently hiring a:Quality Laboratory Supervisor (Center of Excellence)About 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 100 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 (Center of Excellences) of our 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 to the Quality Control Lead, you will manage a laboratory team (around 10-15 people) with the following responsibilities: assure timely generation of changes required by all laboratory areas, manage laboratory instrumentation installation, qualification, calibration and maintenance program, lab deviations and CAPA systems, document changes; you will assure that any related quality issues are provided having the required visibility and resolution in an expedited manner.Other tasks/ responsibilities:* Providing general management and guidance to compliance with company policies, standards, procedures, cGMP s, GLP s, and regulations;* Maintaining up to date analytical procedures used by the company;* Managing directly or through supervisory employees, the microbiology environmental monitoring program pertaining to the manufacturing operations;* Enforcing safety procedures in the laboratory, concerning the analysts and/ or other employees who visit the laboratory area;* Assuring training is provided to the laboratory employees on regulations under the cGMPs requirements and also responsible for the on-the-job training of the team;* Planning, managing and providing quality expertise to cross-functional investigations;* Reviewing and approving investigations associated with all areas of responsibility and providing support on data evaluation, investigation and in exercising sound decision making;* Managing and attending assigned area regulatory inspections;* Supporting management to provide responses to audit observations and findings;* Investigating most probable cause for products trends, complaints and deviations to recommend sound corrective and preventive measures to avoid recurrence;* Managing and monitoring assigned area departmental budget.Qualifications* Bachelor s or Master s degree, preferably in Science or Chemistry;* At least eight years of related experience with at least three years in a supervisory role;* At least six years of experience in lab testing, deviations management, validation, or in technical capacities which support these initiatives;* Strong technical competencies in laboratory equipment, automation, qualification and quality systems;* Knowledge to handle lab related investigations, out of specifications, out of trend results, change controls, etcetera;* Extensive knowledge of cGMP, GLP, and laboratory operations;* Strong supervisory capabilities;* Knowledge of Quality Operations and /or Manufacturing processes and Laboratory testing processes;* Strong knowledge of Risk Management tools to determine impact and mitigating actions due to quality and compliance issues;* Knowledge of and experience in applying Lean Six Sigma and Lean methodologies;* Demonstrated excellent interpersonal skills with the ability to influence, motivate, and lead projects and teams.* Excellent oral and written communication 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 on the position please contact Gabriela Visser, Associate Director/ Quality Control Lead Biotech Oss, by phone: 00 31 6 151 454 57.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:Mgr, QualityPrimary Location: EMEA-Netherlands-NB-OssEmployee Status: RegularNumber of Openings: 1Company Trade Name:MSD Job Segment: Microbiology, Biotech, Laboratory, Law, Manager, Science, Legal, Management

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Oss NL

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