This job is currently Archived,
Posted on : 10 April 2017
- 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.
- Quality Operations Biotech (around 100 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 (Center of Excellence) of our Manufacturing Division as well as regularly interact with other Manufacturing Division sites.
Reporting 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.
- 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 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.
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