Biotech and Agricultural Engineering Management & Business Others Medical and Healthcare Other Science and Tech
3 - 5 Years
September 10, 2019
product quality leader
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, EMEA, ICH etc. To achieve compliance, quality systems are defined, implemented and maintained. The Quality Product Leader is responsible to ensure the regulatory compliance, implementation and adherence to regulatory legislation and corporate guidelines in projects and routine operations. Quality Product Leader is responsible for the disposition decision to the customer of the product manufactured at Thermo Fisher Scientific Groningen.
What will you do?
Responsible for final disposition to customers of cell banks and bulk pharmaceutical products and for managing all activities to enable this disposition in an efficient and cGMP compliant way according the agreements made with the project manager, the client and according to regulatory expectations. Proposes and implements improvements related to quality and compliance;
Advise to project organization and customers on all relevant cGMP matters and assure appropriate cGMP level of project activities;
Serves as quality advisor for investigations and recommends actions to ensure continued compliance and avoiding recurrence;
Reviews and approves cGMP documents associated to the product in compliance with local and corporate SOPs and applicable legislation;
Approves investigations assuring that they are complete, accurate, technically justified with the required documented evidence including risk assessment;
Evaluates and approves Changes associated with the product;
Plan, perform and monitor in collaboration with the project manager QA activities within the project to ensure results are according the agreement and regulatory expectations;
Provides assistance and guidance with regard to the Quality Systems to other departments. Proposes and implements improvements to these systems.
How will you get here?
Academic level in a relevant discipline. (Biochemistry, Microbiology, Biotechnology, Pharmacology).
Minimum of 5 years relevant experience in a (bio) pharmaceutical company;
Experience with project management;
Combination of experience and educational level should be sufficient to act as the person responsible for release of bulk pharmaceutical products
Knowledge, Skills, Abilities
Broad knowledge of pharmaceutical cGMP systems and international cGMP regulations and guidelines;
Planning and organizing;
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.