Biotech and Agricultural Engineering Management & Business Others Medical and Healthcare Other Science and Tech
December 8, 2019
Supervisor, QC Support
When youre part of Thermo Fisher Scientific, youll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Location/Division Specific Information
The Groningen site is a multi-product and multi-client biopharmaceutical site with development and manufacturing facilities for pharmaceutical products for clinical trials (phase 1, 2 and 3) and commercial production.
How will you make an impact?
Manufacturing of biopharmaceutical products is required to be in compliance with international quality requirements as defined by FDA, EMA, ICH etc. To achieve compliance, quality systems are defined, implemented and maintained. The QC Support Manager will manage the QC support team consisting of QC support officers and sample administrators, to assure timely output of the Quality Control department, according the international regulatory requirements.
What will you do?
The QC Support Manager is responsible for performance of the QC support team and timely output according regulatory requirements (cGMP);
All managerial responsibilities for the QC support team, including coaching and support;
Make and execute (career) development and training plans;
Yearly appraisal of direct reports (including target setting);
Responsible for the coordination of the sample flow to contract labs for the Quality Control department at the appropriate quantitative and qualitative level, in order to execute Quality Control activities according to planning;
Responsible for the content of the BOTs ( Bill of testing) on in-house productions;
Responsible for stability program and Reference Standard management;
Responsible to the preparation of Certificates of Analysis, both for internal and external testing, in accordance with the release schedule;
Responsible for alignment of local requirements versus global requirements, e.g. GAP analysis and corrective actions;
Support the Quality Control department in relation to compliance of documentation and change control management, and upon request support to investigations;
Contributes to the effectiveness of the Quality Control department, in order to safeguard the output, whilst operating within EH&S guidelines and Quality standards. Eliminates barriers where processes are being hindered;
Responsible for maintaining the equipment in a GMP operable status, coordinating maintenance, repairs, replacement and improvement of operational status. Support and write validation documents to validate QC equipment;
Responsible for monitoring data integrity status of equipment and corrective actions if required;
Monitor external technological (equipment, facilities, systems & support, assays and contract labs), legal and regulatory developments and assess their applicability to and consequences for the position of Thermo Fisher Scientific Groningen;
Representing the department in audits, giving tours to auditors and/or customers, answering questions;
Replacement of the Quality Control manager upon request or delegation of tasks.
How will you get here?
Bachelors degree (HBO) discipline (Biochemistry, Microbiology, Biotechnology, Pharmacology) or through relevant experience laboratory education and experience in the Quality Control area;
At least five years of relevant experience in a (bio)pharmaceutical company;
At least five years of experience at supervisor /manager level;
Knowledge, Skills, Abilities
Sound knowledge on Quality Control in the pharmaceutical industry;
Expert in English, both in oral and written communication;
Social and communication skills;
Leadership and coaching skills;
Planning and organizational skills.
At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier, cleaner and safer.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.