Company Description
We are the designers of today for the world of tomorrow.
As one of the world's leading engineering service providers, we at ALTEN are committed to positively shaping the future of our partners, the careers of our employees and the challenges facing our society and environment.
More than 50,000 employees in 30 countries are already working on innovative solutions in various engineering and IT sectors such as automotive, aerospace, renewable energy, medical technology and railway technology.
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: Maja Kujundzic (+43 669 10979556).
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.