GMP Compliance Specialist (m/f/d)
GMP Compliance Specialist (m/f/d)
Jobdescription
For our client, an international pharmaceutical company based in Basel, we are looking for a GMP Compliance Specialist.
The perfect candidate has a Bachelor or equivalent and/or higher degree in chemistry, biology or pharmaceutical sciences or operational experience in a GMP environment within the pharmaceutical industry. Experience in synthetic molecule manufacturing and/or quality control, as well as knowledge of GMP regulations (e.g., ICH Guidelines) and principles of quality systems is a plus.
General Information:
Tasks & Responsibilities:
Must Haves:
For our client, an international pharmaceutical company based in Basel, we are looking for a GMP Compliance Specialist.
The perfect candidate has a Bachelor or equivalent and/or higher degree in chemistry, biology or pharmaceutical sciences or operational experience in a GMP environment within the pharmaceutical industry. Experience in synthetic molecule manufacturing and/or quality control, as well as knowledge of GMP regulations (e.g., ICH Guidelines) and principles of quality systems is a plus.
General Information:
- Start date: ASAP
- Planned duration: 1 year contract
- Extension: not likely
- Workplace: Basel
- Workload: 80% -100%
- Remote/Home Office: at least 3-4 days per week onsite
- Working hours: Standard
Tasks & Responsibilities:
- Management of local and global compliance processes like GMP training, archiving, quality risk management, handling of multisite and local impact assessments
- Being an expert and first level support for relevant quality systems (e.g. Cornerstone, Veeva OneQMS, QualityDocs, QRM,)
- Managing changes and deviations, as well as corrective and preventive actions in consultation with QA
- Provide expert support to monitor, update, and adapt the GMP-relevant document landscape within pCMC
- Participating in the preparation and coordination of internal and health authority audits, as well as supporting the timely implementation of inspection findings
- Collaborating with team members in a role based working environment, as well as building and growing relationships with customers and partners across functional boundaries
Must Haves:
- Bachelor or equivalent and/or higher degree in chemistry, biology or pharmaceutical sciences
- Operational experience in a GMP environment within the pharmaceutical industry
- MS office / standard Google applications
- Fluent in German, good verbal and written communication skills in English
- Soft skills: detail-oriented and analytical mindset; ability to identify potential deficiencies, propose solutions, and effectively interpret and apply regulatory requirements; excellent communication skills; ability to collaborate efficiently with interdisciplinary teams in a dynamic environment.
- Experience in synthetic molecule manufacturing and/or quality control, as well as knowledge of GMP regulations
(e.g., ICH Guidelines) and principles of quality systems is a plus.
Audrey Bisch
Über die Firma
