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Corporate Quality Assurance Manager
As a Corporate QA manager you are responsible for the appropriate vendor qualification of suppliers of intermediates and drug substances (DS) and drug product (DP) contract manufacturers used by Synthon (vendor management and auditing). You closely work together with other relevant departments in our organization (e.g. DMF, RA, API procurement, Qualified Persons) to assure a proper planning and compliance with relevant requirements.
In addition, you provide excellent project advice to the Synthon organization including subsidiaries. You handle relevant quality issues and you participate in the maintenance and improvement of Synthon’s pharmaceutical quality systems and in the alignment of subsidiaries. You perform quality overview of Synthon subsidiaries and DS suppliers/DP contract manufacturers, detecting and analyzing any trends and promoting continuous improvement of the quality systems.
QA administration of corporate quality systems and documentation software (Trackwise, Doc Compliance), and writing and maintaining the quality manual, policies and SOPs are also important activities in your role. Besides, you support the implementation of new regulations and systems and support critical external audits/inspections from customers and/or authorities to Synthon sites or contract companies. Finally, you perform internal (Synthon subsidiaries) and external audits globally (mainly in China and India), including reporting and follow-up. You will be part of a corporate team based in the Netherlands and in Spain, reporting to the director of Corporate QA and you will be working on dynamic and challenging strategic projects to achieve the objectives of the Corporate QA department.
Your letter of motivation and CV should show that you have:
• A bachelor’s or master’s degree in life sciences or chemistry
• At least four years of work experience in the pharmaceutical industry, e.g. in QA or production
• Proven knowledge of international pharmaceutical quality system requirements of the pharmaceutical industry for human drugs and knowledge of the regulatory requirements of the recognized regulatory authorities to enable an assessment of the applicability and compliance with such laws, regulations and standards
• An excellent verbal and written command of the English language.
In interviews you will be able to demonstrate that:
You are motivated and strongly results-oriented. In addition, you have a flexible and pragmatic approach. You can clearly communicate with different stakeholders (internal and external). You are used to working on multiple projects simultaneously. You take initiative to get tasks accomplished and you have the ability to meet challenging timelines. Besides, you are able to build and maintain relationships with our customers and colleagues.
Contract hours: preferably full time (40 hrs).
Salary: scale 15 or 16, depending on education and experience.
Contract: initially fixed term with a view towards an indefinite contract.
Synthon is an international pharmaceutical company, and a leader in the field of generic human medicines. Founded in 1991, Synthon has been working in biotechnology since 2007 and is developing rapidly into a specialty pharmaceutical company. Our mission is to make healthcare more affordable and to increase access to important medicines through the provision of high quality generics and new biological and chemical entities - specifically in the therapeutic areas of oncology and autoimmune diseases. Currently our products are approved by regulatory agencies in more than 90 countries and marketed through strategic partnerships and – in dedicated areas – through direct sales.
Synthon’s head office is based in Nijmegen, the Netherlands, and the company has affiliates in eight other countries. In 2016, it recorded a turnover of EUR 258 million. The company employs around 1,900 staff of whom over 500 work in Nijmegen.
We are interested in result-oriented people with a sharp mind and entrepreneurial spirit, who can contribute to what we do best: delivering affordable and innovativemedicines to those in need.
For further information please contact Gert Klein Kranenbarg, VP Quality and Drug Safety at phone +31 (0)24 372 77 00 and/or Merche López, Director Corporate QA at phone (+34) 93 640 15 16. If you are interested in this challenging position, then please send you application (in English!) via the apply button / link.
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