CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Astellas Pharma Europe B.V., we are searching for a QA Specialist.
Astellas is a Japanese multinational pharmaceutical company employing over 17,000 people worldwide with global sales exceeding 11 billion euro. The group’s EMEA headquarters are based in London, with affiliates throughout Europe engaged in research & development (R&D), manufacturing and sales & marketing. With over 4,500 employees, EMEA is an important and growing Astellas region, having key strengths in the therapy areas of Urology, Transplantation, Anti Infectives, Pain Management and Oncology. The global annual R&D investment of 15% to 20% of sales is evidence of the group’s commitment to improving the health of people worldwide through the provision of innovative and reliable products. Astellas employs around 950 persons in the Netherlands, in Leiden and Meppel.
Are you looking for a challenging position in an international pharmaceutical company? Can you easily deal with different cultures and quality regulations of non EU countries And do you have experience in Quality Assurance? This might be the perfect job for you!
The purpose of the position is to further setup, maintenance and implementation of the pharmaceutical quality management system as well as performance of several measures to secure the quality management of the Affiliate and its third parties.
Main tasks and responsibilities:
- Check and prepare quality agreements with local country third parties in accordance with internal and external regulations;
- Perform audits of local country third parties, as appropriate;
- Conduct self - inspections according to the approved self - inspection plan;
- Ensure local GMP / GDP procedures are maintained in the Astellas Document Management Systems (ADMS);
- Ensure that only approved Local Service Providers are used, if applicable;
- Collaborate with LSPs to ensure Quality Assurance requirements are followed and maintain appropriate QA oversight for GDP operations and warehouse management;
- Properly document changes with potential impact on GDP/GMP compliance, ensure that changes are approved by the RP and implement the changes in accordance with the agreed timelines;
- Perform validation activities for local GDP / GMP systems, as required;
- Review the Product Quality Review reports in a timely manner;
- Support the RP in case of SQI’s and recalls;
- Prepare for GDP/GMP Inspections by Competent Authorities, and assist the Quality Assurance Lead & Responsible Person during these inspections;
- Prepare for QA Internal audits, and assist the Quality Assurance Lead & Responsible Person during these internal audits;
- Prepare monthly KPI report , ensure approval of the KPI report by the Quality Assurance Lead & Responsible Person, and submit the KPI report to the QA Sub -region lead;
- You will report to the QA lead or QP.
Who we're looking for
We are looking for a candidate with a degree in Science or health and at least 5 years of (QA) experience in the pharmaceutical industry. You have good knowledge of EU GDP, EU GMP and Quality management systems.
You fit the following description :
- Ability to communicate and negotiate with peers;
- Understanding of local and European regulatory environment;
- Experienced in handling regulatory interfaces such as inspections and audits;
- Good organizational, coordination, diplomatic, negotiation, presentation and communications skills;
- Precise, rigorous and reliable with an analytical mind;
- Good decision making skills.
Additional vacancy information
Contract: Temporary contract with CLS Services
Terms: Project for one year. Full time highly preferable.
Contactperson: René Kemps
Phone: +31 (0)88 22 77 555