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Qualified Person
Posted 12 days 10 hours ago by Dr. Reddy's Laboratories
Permanent
Not Specified
Other
Noord-Holland, Amsterdam, Netherlands
Job Description
What you enjoy
- As a Qualified Person, you take on the tasks of the Qualified Person according to 14 AMG and ensure the relevant batch releases
- You will manage a small team of currently two employees in operational, disciplinary and technical terms, who support you with batch certification
- You will supervise new product launches and take part in inspections by the authorities on site and, if also in third countries if interested
- You will be responsible for ensuring and maintaining GxP-compliant QMS systems and working on lean management projects
- The creation of QP declarations, as well as review and evaluation of product quality reviews is also part of your tasks
- In addition, you will act as an interface to our national and international contract manufacturers and assist with supplier evaluations and, if necessary, participation in audits
That makes us curious
- You have many years of experience as a Qualified Person and in drug release
- Ideally, you also have management experience and experience in the release of biologicals
- You are a pharmacist or scientist with extensive industry experience and the required expertise in accordance with 15
- You have many years of experience in the GMP/GDP environment and are proficient in all MS Office programs, SAP and other pharma-specific software
- You have a careful and structured way of working, a confident manner and excellent communication skills characterize you
- Very good written and spoken German and English skills round off your profile
What we offer
- If you are interested, we offer you the opportunity to train as an auditor for audits of contract manufacturers, laboratories or external warehouses
- Varied tasks within an internationally successful group
- A distinctive collegial atmosphere embedded in an appreciative and employee-oriented corporate culture
- An attractive salary and extensive social benefits, such as a company pension scheme, company party, fuel vouchers, ice cream in summer, barbecues, free drinks,
- Flexible working hours with time account and home office option
- Development and training opportunities
