Mont-Saint-Guibert, Wallonia, Belgium · Hybrid
En tant que QA Operations Officer, vous êtes le garant de la conformité aux Bonnes Pratiques de Fabrication (BPF/GMP), de Distribution (GDP) et aux exigences réglementaires applicables. Vous jouez un rôle central dans le…
Skills: GMP Compliance, GDP Compliance, Quality Management System, Batch Record Review, Deviation Investigation
Weybridge, England, United Kingdom · Remote OK
Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines…
Skills: Contract Negotiation, CDA Preparation, Legal Administration, Compliance Monitoring, Intellectual Property Support
Shah Alam, Selangor, Malaysia · On-site
About the role The HR Operations Specialist ensures efficient, compliant and high quality delivery of HR services across the employee lifecycle in several countries in the region. This role plays a key part in maintainin…
Skills: HRIS, Employee Onboarding, Offboarding, HR Reporting, Office Administration
Tokyo, Tokyo, Japan · Hybrid
Position Summary: The Regulatory Affairs Manager will lead regulatory assessment and execution of post-approval changes for products in Japan, collaborating with internal teams, global colleagues, and external partners t…
Skills: Regulatory Affairs, Change Control, CMC, Japanese Pharmaceutical Regulations, Post-Approval Changes
Malvern, Pennsylvania, United States · On-site
Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines…
Skills: Packaging, Labeling, Documentation, Good Documentation Practices (GDP), Current Good Manufacturing Practices (cGMP)
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Ensure compliance with GMP and GDP standards through the review of batch records and the release of medicinal products. Manage quality documentation, participate in deviation investigations, and support regulatory inspections and audits.
Requires a Bachelor's degree in Health Sciences (Pharmacy, Biology, Chemistry) and confirmed experience in GMP/GDP environments. Proficiency in French is essential, with English being highly desired.
En tant que QA Operations Officer, vous êtes le garant de la conformité aux Bonnes Pratiques de Fabrication (BPF/GMP), de Distribution (GDP) et aux exigences réglementaires applicables. Vous jouez un rôle central dans le maintien d'un Système de Management de la Qualité robuste et dans la libération des produits en conformité avec les standards de l'industrie.
Vous reportez directement au QA/QC Manager du site CCSM Belgium.
Responsabilité Principales
▸ Contrôle Qualité & Libération
▸ Assurance Qualité & Documentation
▸ Inspections & Audits
▸ Communication & Amélioration Continue
Formation
Expérience & Compétences techniques
Compétences comportementales
Langues
A world where access to medicines is global by design
Helping biopharmaceutical companies bring treatments to patients worldwide through clinical supply, managed access and global partnering solutions.
Offices: 25 Bedford Square, Bloomsbury, London, England WC1B 3HW, GB · Pitcairn House, Crown Square, First Avenue, Burton on Trent, Staffordshire DE14 2WW, GB · Idis House, Churchfield Road, Weybridge, England KT13 8, GB · 5 Apollo Street, Warriewood, Sydney NSW 2102, AU · Level 31, Vero Centre, 48 Shortland Street, Auckland, Auckland 1140, NZ
A world where access to medicines is global by design
Helping biopharmaceutical companies bring treatments to patients worldwide through clinical supply, managed access and global partnering solutions.
Offices: 25 Bedford Square, Bloomsbury, London, England WC1B 3HW, GB · Pitcairn House, Crown Square, First Avenue, Burton on Trent, Staffordshire DE14 2WW, GB · Idis House, Churchfield Road, Weybridge, England KT13 8, GB · 5 Apollo Street, Warriewood, Sydney NSW 2102, AU · Level 31, Vero Centre, 48 Shortland Street, Auckland, Auckland 1140, NZ
