Progressive is looking for:
Senior Specialist Quality Assurance/Responsible Chemist
Duration: long term - full time preferably
This company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. They are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Quality Operations (around 100 people) in Oss has the following five sub-functions: Quality Assurance, Quality Systems, Quality IPT, Quality Control and Biological Critical Reagents Hub. The Quality Department must ensure adequate quality systems are in place to support the manufacture, packaging, testing, storage, and distribution of drug substances according to corporate policies, Guidelines, Procedures and regulatory requirements by appropriate oversight and monitoring.
Reporting into the associate Director Quality/IPT Quality lead, the Senior Specialist Quality Assurance will be responsible for the release of incoming goods, and IPT products and processes in full compliance with quality procedures, legal guidelines, quality guidelines and market authorization. He/she will be responsible for advice on and improvements of quality related issues, in order to ensure an optimal quality of released products and processes.
Next to that the Senior Specialist Quality Assurance will be responsible for:
- Authorization of documents, deviations, changes and special requests that may impact product quality;
- Contribution to the IPT's and CoE's quality strategy by prioritizing, initiating and monitoring related improvements as agreed upon;
- Co-ordination of the execution of the recall procedure; is responsible for product recall execution;
- Working within general standards of industry, governmental expectations and policies and guidelines;
- Contributing to continuous improvement of quality within Biotech Operations;
- Being the Team Lead or member in a number of different projects (both product and process related);
- Being eligible to be Quality Lead or captain in global product teams (e.g. IDST).
- University Degree (Pharmacy, Biology or Biotechnology) or Higher education.
- At least five years of experience in Quality Assurance, Quality Control or related technical field (experience in biologics is a plus);
- Strong project management skills (e.g. Green Belt/Black Belt certified or willing to obtain degree);
- Broad technical competencies with past exposure to manufacturing, analytical or clinical environments;
- Cross-functional quality experience (e.g. batch release, change management,
investigations, audits etc.);
- Strong background in manufacturing and/or R&D;
- Excellent writting and verbal skills in English and Dutch.
Contact for more info: Elke van den Boom - Progressive 020 530 5888
e.vandenboom @ progressive-nl.com
Progressive Recruitment is gespecialiseerd in de bemiddeling van professionals binnen de sectoren IT, Global Energy & Natural Recources, Life Sciences, Supply Chain en Engineering. Wij kunnen je helpen bij je zoektocht naar een tijdelijke opdracht, maar ook als je zoekt naar een permanente functie in deze sectoren. Kijk voor meer informatie op www.progressiverecruitment.com of www.progressivege.com
Progressive Recruitment is specialized in recruiting professionals in the sectors IT, Global Energy & Natural Recources, Life Sciences, Supply Chain and Engineering. We can help you find temporary and permanent job opportunities in these industries. For more information, visit www.progressiverecruitment.com or www.progressivege.com.