Sr. Quality Assurance Manager
Centrient Pharmaceuticals Netherlands, Netherlands
Job Description
Centrient Pharmaceuticals is the leading manufacturer of beta-lactam antibiotics, and a provider of next generation statins and anti-fungals. We produce and sell intermediates, active pharmaceutical ingredients and finished dosage forms.
We stand proudly at the centre of modern healthcare, as a maker of essential and life-saving medicines.
With our commitment to Quality, Reliability and Sustainability at the heart of everything we do, our over 2200 employees work continuously to meet our customers’ needs. We work towards a sustainable future by actively participating in the fight against antimicrobial resistance.
Founded 150 years ago as the ‘Nederlandsche Gist- en Spiritusfabriek’, our company was known as Gist Brocades. Headquartered in Rotterdam (Netherlands), we have production facilities and sales offices in China, India, the Netherlands, Spain,the United States and Mexico. Centrient Pharmaceuticals is wholly owned by Bain Capital Private Equity, a leading global private investment firm.
The Quality department of the business Unit FDF has a vacancy in its Rijswijk offices, for the following position:
Sr. Quality Assurance Manager
The main activities and responsibilities
- You ensure compliance, perform qualification audits and advice on improvements at Contract Manufacturing Organizations (CMO’s), Contract Laboratories, Contracted logistic providers, Contract Research Organizations (CRO’s) and API manufacturers.
- You are participating in work streams to support and guide multi-disciplinary change projects, including qualification and validation of new products and processes, dealing with contract manufacturers, contracted laboratories and in the near future an own drug product factory.
- You work closely together with other functions like Regulatory affairs, Operations and Ramp;D.
- You have the ability and flexibility to deal with different quality requirements for pharmaceutical drug products.
- You are bringing hands on support in setting up and revising quality agreements with Contracted companies and Customers.
- You are involved in both internal, supplier and contract manufacturer audits.
- Primary contact and QA responsible for contracted parties.
The Ideal Candidate
- You have a Master in Science, preferably in Pharmacy.
- You can act as a Qualified Person for release of Pharmaceutical Drug Products in Europe and you are familiar with the requirements for manufacture of Pharmaceutical Drug Products for supply to U.S. and ROW (and preferably other regulated) Markets.
- You can facilitate training to ensure all our employees live up to the applicable quality standards.
- Ideally you have experience with and training in Continuous Improvement and Functional Excellence programs such as Six Sigma.
- You should be a Certified Auditor with extensive experience in performing audits.
- You should be well organized with aptitude for working in multi-functional and multi-cultural teams with experience in working internationally.
- You should enjoy business travel and be willing to travel up to 25% of your time.
- You have at least 8 years’ experience in the Pharmaceutical Industry in the manufacture and packaging of Pharmaceutical Drug Products (solids as well as sterile).
Substance:
- You have excellent verbal and written communication skills in English.
- You have strong project management skills.
- You are a good team player.
- You are proactive, energetic and a strong communicator and relationship builder.
- You are focused on continuous improvements and possibilities.
- You are capable working under pressure.
- You need to be able to do multiple tasks parallel to each other and still keep the oversight.
- You are result oriented, persuasive and pragmatic.
Terms and reward
We offer a challenging job with many opportunities for personal input, plenty of room for discussions with fellow professionals and an open, very international and pleasant atmosphere. Terms and conditions of employment as well as fringe benefits are up to market standards. Salary depends on your education and experience and is based on the local Collective Labour Agreement.
The Procedure
Please submit your application before April 14, 2021 via the 'apply' button and upload your CV amp; cover letter in English. We also ask you to include information on your current remuneration. Only applications with CV and Cover Letter will be considered.
For more detailed information about the role and about the Recruitment amp; Selection process you can contact us via . We invite you to visit our website www.centrient.com for i