Job Description
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 CP-related 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 cross-functional 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 self-motivated and structured in daily work
* have strong communications skills
* are a team player and Customer oriented
* can work with MS Office- and other standard IT-applications
* 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: Suada Cisic Salkovic (+43 699 14148502).
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.