Client: Gi Group SA
Location:
Job Category: Other
Job Reference: f424e7c24a4d
Job Views: 6
Posted: 22.01.2025
Expiry Date: 08.03.2025
Job Description: For our partner in the pharmaceutical industry, Gi Life Science is looking for a:
Your mission:
Ensure that each product is continuously manufactured, packaged, and tested in compliance with the Marketing Authorisation Dossier managed by the Customer/Product Owner and also to support the site in the Company Regulatory Surveillance initiatives.
Responsible to ensure the proper support of the GMP stakeholder regarding the Product's Dossier and the Regulatory Surveillance.
Collaboration with the other members of the QLT to ensure that the Quality Systems are maintained and improved and that any cGMP compliance issues are duly addressed in a timely manner.
Your responsibilities:
Act as the deputy of the Responsible Person (RP) according to the Swiss Ordinance on Establishment Licenses and of the Qualified Person according to the EU Guide to Good Manufacturing Practice.
Act within the site's key projects teams as the main Quality representative and single point of contact for QA, Compliance, Quality Supplier, and Regulatory Affairs.
Act as the point of contact with customers for quality topics, coordinating responses/notifications to the client related to quality topics.
Coordinate and drive quality activities related to:
Technology tech transfer.
Analytical tech transfer.
Raw materials introduction.
Manufacturing specifications.
Conduct assessment of change controls for site-related projects and/or for product life-cycle projects with relevant quality SMEs and act as the site interface with Global Regulatory (CMC & Affairs).
Support responses related to regulatory authorities' requests, e.g., in the scope of submission or periodic GMP review.
Actively support site Quality activities such as:
Multi-site investigations, drive change controls upon requests.
Review of MBR and executed batch records related to NPI.
Health authority and client inspections.
Ensure compliance with the policy of security at work and to laws concerning health and security of the workers within the area of responsibility.
Work closely with EHS to evaluate hazards and perform risk analysis.
Promote safe practices and behaviors, verify that EHS rules are implemented and followed.
Your profile:
BSc or MSc degree in Pharmacy, Chemistry, Microbiology, or related science.
Minimum 7 years of experience in Quality Assurance, Quality Control, and/or Regulatory Affairs in a pharmaceutical company or other related industry.
Solid understanding of cGMPs and Swiss, EU, and FDA regulatory requirements.
Solid knowledge of Oral Solid Dosage form manufacturing, packaging, testing, warehousing processes, validation, and registration.
Excellent investigational and QA problem-solving skills.
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