Senior Manager QA/RA Projects
vor 3 Wochen
Senior Manager QA/RA Projects
(Permanent position)
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 is 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 customer for quality topics, coordinates response / notification to the client related to quality topics
· Coordinate and drive quality activities related to:
o Technology tech transfer
o Analytical tech transfer
o Raw materials introduction
o Supplier qualification
o Manufacturing specifications
o CMC dossier set up
· 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 response related to regulatory authorities requests, e.g. in the scope of submission or periodic GMP review
· Actively support site Quality activities such as :
o Multi sites investigations, drive change controls upon requests
o Review of MBR and executed batch record related to NPI
o Internal audits (as auditor)
o Health authority and client inspections
o Continuous improvement
· Ensures compliance to the policy of security at work and to laws concerning health and security of the workers within the area of responsibility
· Works closely with EHS to evaluate hazards and perform risk analysis
· Promotes 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
· Min. 7 years of experience in Quality Assurance, Quality Control, and/or Regulatory Affair 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
· Language: French and English
Your contact at Gi Life Science:
Manon Tenaud +41 22 737 12 07
Marko Durakovic +41 22 737 12 09
Branche:
Funktion:
Anstellungsart: Festanstellung
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