YOU
- are responsible for planning oversight and management of the Control Procedure (CP) system within CQF in accordance with the GMP regulations and internal data management systems (e.g. CONDOR)
- evaluate and implement pharmacopoeial changes
- take over the change management/coordination of CPs with respect to compendial testing internal testing and specification etc.
- coordinate CPrelated projects with internal and external business partners
- plan and implement periodic reviews of CPs within CQF in close collaboration with the QA and QC
- collaborate and optimize crossfunctional activities regarding CPs (QSS QC labs etc.) and in other GMP work streams
- are leading projects to optimize workflows authoring SOPs
- participate and preparate inspections and audits by customers and health authorities
- are the expert support for QC Production Registration and QA
- handling questions and requests (e.g. translations) from health authorities and Registration
- lead and support deviation investigations pertaining to control procedures
- support implementing CAPAs pertaining to control procedures (e.g. from OOS or deviation cases)
- take over the management of external laboratories in topics relating to CP updates
- will be responsible for general administrative and organisatorial tasks
- create and manage reports
Qualifications :
YOU
- have an academic background with natural science/technological background or equivalent education
- have relevant professional experience in a GMP environment or equivalent
- are able to make complex decisions
- already have some knowledge of the business area
- have knowledge of GMP principles
- are quality and results driven
- are highly selfmotivated and structured in daily work
- have strong communications skills
- are a team player and Customer oriented
- can work with MS Office and other standard ITapplications
- are fluent in German and English (oral and written)
Salary starting at 4.000 gross per month based on 38.5 h/week with the express willingness to overpay depending on qualifications and experience.
We value diversity and therefore welcome all applications regardless of gender nationality ethnic and social origin religion/belief disability age and sexual orientation and identity.
Severely disabled persons will be given preferential consideration if they are equally qualified.
Do you have any questions
Then contact me: Loredana Dobos (Tel.:).
Or apply now using our online application form.
Additional Information :
- .Talent Management we develop your career
- Work life balance flexible working hours and mobile working possible
...and of course we offer the usual standards such as 25 days holiday many events permanent employment contract and corporate benefits.
Remote Work :
No
Employment Type :
Fulltime