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Quality Laboratory Coach - in vitro Pharmacology Job

Date: Nov 22, 2017

Location: Oss, NB, NL

Company: MSD

Requisition ID: QUA006255

For our Pharm Ops Quality Operations organization in Oss we are currently hiring a:

Quality Laboratory Coach in vitro Pharmacology (Center of Excellence)


The organization
Quality Operations Pharm Ops (around 250 people) is responsible for ensuring that our Manufacturing Division Oss manufactures, tests and releases 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.



The Department
The Quality Control – Microbiology & Pharmacology (QC-M&P) laboratory is responsible for ensuring the biological quality of Pharmaceuticals and Biotechnological Products produced at MSD Oss as part of the Quality Operations Pharm Ops. As part of QC M&P, the in vitro pharmacology team has expertise in cell based assays and Quantitative Polymerase Chain Reaction (Q-PCR) assays within a GMP lab environment and supports activities for both Pharmaceutical Operations Oss and Biotech operations Oss and has close relationships within the MSD network regarding these technologies, including the Center of Expertise of adventitious viral agents (CoE-AVA) based in Oss.

The Position
Reporting to the Lab Manager of Quality Control Microbiology & Pharmacology, you will manage a laboratory team (around 7 – 12 people in the future) with the following responsibilities: assure GMP compliant and timely analysis of release, stability batches and special analytical requests.

Tasks and responsibilities



  • Providing general management and guidance to compliance with company policies, standards, procedures, cGMP’s, GLP’s, and regulations and sponsors an GMP compliance culture with focus on both customer needs and continuous improvement;

  • Maintaining up to date analytical procedures and other types of GMP documentation;

  • Ensuring validation of analytical methods for batch release or process characterization to support the QC of biotechnological products;

  • Enhances (biosafety) safety culture and ensures (bio)safety policies and guidelines are followed;

  • Responsible and accountable for lab deviation handling including corrective and preventative compliance actions;

  • Monitoring of QC of assay performance to ensure stable analysis over time;

  • Acts as the in vitro pharmacology representative during internal audits and governmental inspections and supports management to provide responses to audit observations and findings;

  • Develops and sponsors Promotes and displays “Lean” behaviors and “Lean” culture. Coaches and develops his/her team to customer focus with an understanding of the capacity needed to fulfil customer demand;

  • Demonstrates leadership through his/her behaviors in alignment with MSD Leadership Standards and the 12 Inclusive Behaviors. Fosters an environment where inclusion, engagement, empowerment and accountability are the "how". Assures reports have the capabilities to do their jobs and takes responsibility for growing and developing talent.
Qualifications

 



  • Bachelor’s or Master’s degree in Life Science

  • At least eight years of experience in Q-PCR/cellular assay testing with at least three years in a supervisory role;

  • At least six years of experience in lab testing, deviations management which support these initiatives;

  • Extensive knowledge of cGMP or other quality related systems; a.o. how to handle lab related investigations, out of specifications, out of trend results, change controls, etcetera;

  • Strong supervisory and coaching capabilities;

  • Knowledge of Quality Operations and /or Manufacturing processes and Laboratory testing processes;

  • 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 writing and verbal skills in English and Dutch

  • Preferably, knowledge of biosafety guidelines and policies

  • Preferably, technical competencies in laboratory equipment, automation, qualification and quality systems

About MSD
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.


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


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 on the position please contact Elma Loomans, Director/ Quality Control QC-Microbiology & Pharmacology, Oss, by phone: 0412- 662307.

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



Job: Quality Operations
Other Locations:
Employee Status: Regular
Travel:
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Microbiology, Biotech, Pharmacology, Laboratory, Pharmaceutical, Science, Healthcare