QC Supervisor (ad interim)
- Job type: Contract
- Salary: €60 - €80 per hour
- Location: North Brabant
- Reference: RE-32496658
Quality Laboratory Supervisor (Incoming Lab)
The Quality Department (around 100 people) is responsible for ensuring that our Manufacturing Division manufactures, tests and releases 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.
Reporting into 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 deviation and CAPA systems, document changes and you will assure any related quality issues are provided 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;
* 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;
* 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;
* Extensive knowledge of cGMP, GLP, and laboratory operations;
* Strong technical competencies in laboratory equipment, automation, qualification and quality systems;
* Strong supervisory capabilities;
* Knowledge of Quality Operations and /or Manufacturing processes and Laboratory testing processes;
* Knowledge to handle investigations and problem solving;
* 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 writing and verbal skills in English and Dutch.
* Competitive hourly rate
* A freelance contract until 31 March 2017
* A temporary position in a multinational company
* Opportunity for a long term/fixed contract
Could this be your next project? Please send me (Jasper Jol) your resume or call me at +31 20 522 1588.