In this role, you will oversee the planning and management of control procedures, ensuring compliance with regulations while coordinating projects and supporting quality functions across various departments.
Anforderungen
- •Academic background in natural science
- •Professional experience in GMP environment
- •Ability to make complex decisions
- •Knowledge of business area
- •Knowledge of GMP principles
- •Quality and results driven
- •Highly self-motivated and structured
- •Strong communications skills
- •Team player and customer oriented
- •Proficiency with MS Office applications
- •Fluent in German and English
Deine Aufgaben
- •Plan and manage the Control Procedure system.
- •Evaluate and implement pharmacopoeial changes.
- •Coordinate change management related to CPs.
- •Manage CP-related projects with partners.
- •Plan periodic reviews of CPs with QA and QC.
- •Optimize cross-functional activities regarding CPs.
- •Lead projects to optimize workflows and author SOPs.
- •Prepare for inspections and audits from authorities.
- •Provide expert support to QC, Production, and QA.
- •Handle inquiries and requests from health authorities.
- •Lead deviation investigations related to control procedures.
- •Support implementation of CAPAs for control procedures.
- •Manage external laboratories on CP updates.
- •Perform general administrative and organizational tasks.
- •Create and manage reports.
Deine Vorteile
25 days' holiday
Various events
Permanent employment contract
Corporate benefits
Original Beschreibung
## 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.
## 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.