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Senior Quality Manager(m/w/x)

SGS
Langkampfen
ab 4.000 / Monat

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.
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