Senior Compliance Specialist | Senior Compliance Specialist | M/W/D - Referenz 001158
consult16 GmbH
Job Summary
As a Senior Compliance Specialist, you will play a pivotal role in the GMP-related qualification of disposables and packaging materials for a leading international pharmaceutical company. Your day-to-day responsibilities include managing complex cross-functional change control processes, drafting and revising GMP documentation such as specifications and SOPs, and overseeing the lifecycle management of materials. You will act as a key interface between Supply Chain, Quality Assurance, and Production. Additionally, you will handle deviations, investigations, and CAPAs, while supporting the preparation for audits and inspections. This role requires a strong regulatory mindset and the ability to drive quality events to completion under strict timelines. The position offers a hybrid work model, allowing for remote flexibility while requiring on-site presence in Biberach for critical meetings and initial onboarding. This is an excellent opportunity for a seasoned professional to apply their pharmaceutical expertise in a dynamic, project-driven environment.
Required Skills
Education
Completed Diploma or Master's degree in Pharmacy, Chemistry, Biotechnology, or a comparable field.
Experience
- Professional experience in pharmaceutical quality control
- Demonstrated experience in the assessment, monitoring, and implementation of GMP requirements
- Experience in managing regulatory requirements for disposables and packaging materials
- Proven track record in handling deviations, investigations, and CAPA processes
- Experience in cross-functional collaboration and stakeholder management within a production environment
Languages
Additional
- Work location is Biberach; hybrid model with required on-site presence for meetings and onboarding. No travel or accommodation expenses covered by the employer. Fixed-term contract until June 30, 2027, via temporary employment (ANÜ).
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