GMP Compliance Specialist
For our client, a pharmaceutical company in Basel, we are looking for a
GMP Compliance Specialist
The perfect candidate: You have 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.
You are fluent in German and have good verbal and written communication skills in English.
You have a detail-oriented and analytical mindset with the ability to identify
potential deficiencies, propose solutions, and effectively interpret and apply regulatory requirements.
You demonstrate excellent communication skills and the ability to collaborate efficiently with interdisciplinary teams in a dynamic environment.
You appreciate being empowered to make decisions in your own field of expertise and actively seek feedback from others.
General Information:
• Start date: asap
• latest Start Date: June 1st
• Planned duration: 1 year
• Extension (in case of limitation): not likely
• Workplace: Basel
• Workload: 80-100%
• Remote/Home Office: at least 3-4 days per week onsite
• Travel: not expected
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.(*****)
Nice to Have:
• 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.
* Info: Please note that this job posting will be halted 21.04.2024
For further information please contact zahra.safari (at) kellyservices.ch
Address
Kelly Services Switzerland
Zahra Safari
