Quality Assurance Technician Junior

hace 2 semanas

Santa Perpètua de Mogoda, España Centrient Pharmaceuticals Netherlands A tiempo completo

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 and more recently DSM Sinochem Pharmaceuticals. Headquartered in Rotterdam (Netherlands), we have production facilities and sales offices in China, India, the Netherlands, Spain, Egypt, the United States and Mexico. Centrient Pharmaceuticals is wholly owned by Bain Capital Private Equity, a leading global private investment firm.
The Position
Support to the compliance manager according GMP's processes promoting compliance and internal adaptation to the Corporation's requirements.
The main activities and responsibilities
- Review and sign the Certificate of Analysis for Customers, checking CSO when applicable.
- Review and test preparation shipments.
- Manage internal quality audits and Good housekeeping and propose improvements actions to achieve quality standards.
- Prepare reports which reflect relevant issues related to quality of manufactured products.
- Manage and participate to staff GMP’s training program from all departments.
- Control research documentation for investigating mistakes, process change and recovering process.
- Develop and coordinate Validation’s Plan and Revalidation.
- Supervise the implementation of stability studies.
- Tracking periodic calibrations of plant’s instrumentation.
- Achieve objectives related to the standards GMP and Good Housekeeping improvements ( internal quality audits, validation plans and audit control).
- Prepare annual products reviews according to the products manufactured.
- Update Sop's Quality Management Department.
- Review methodical analytics.
- Prepare for new processes VMP.
- Key user's SAP and other IT quality systems.
- Participate on project, committees and subcommittees representing QA role.
- Education in Chemistry or a similar discipline.
- + 2 years of experience in Quality Assurance department in pharmaceutical or chemical industry.
- Experience in Quality Management software: electronic documentation management system and SAP.
- Knowledge in GMP's.
- Knowledge in Trackwise.
- Knowledge of audit quality procedures.
- Fluency in English and Spanish.
- Able to work in multidisciplinary teams.
- Communication skills

Terms and reward
We offer a local contract in a challenging, comprehensive, operational environment, with many opportunities for personal input and growth and plenty of discussions with other professionals. The organization is very flat. You have a lot of freedom and responsibility in an open, direct and informal atmosphere.
The Procedure
Reference check procedures are part of the Centrient Recruitment & Selection Process. You will be contacted when a reference check is required.

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