Senior Manager QA/RA Projects
Vor 4 Tagen
For our partner in pharmaceutical industry, Gi Life Science is looking for a:
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: Pharma-Industrie
Funktion: Middle und Top Management
Anstellungsart: Festanstellung
-
Senior Manager QA/RA Projects
vor 4 Wochen
Neuenburg, Neuenburg, Schweiz Gi Group SA VollzeitFor our partner in pharmaceutical industry, Gi Life Science is looking for a: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...
-
Neuenburg, Neuenburg, Schweiz Gi Group SA VollzeitJob Description:Gi Life Science is seeking a highly skilled Senior Manager to lead their QA/RA projects.About the Role:The successful candidate will be responsible for ensuring that all products are manufactured, packaged, and tested in compliance with regulatory requirements. This includes supporting the site in Company Regulatory Surveillance initiatives...
-
QA Representative
vor 38 Minuten
Neuenburg, Neuenburg, Schweiz gloor&lang AG VollzeitAbout the JobGloor&lang AG is a leading biopharmaceutical company seeking a QA Representative to join its Pharma Operations team and support the implementation of CAPEX projects.About the RoleAs a senior professional in Quality Projects, you will serve as the Quality Validation representative for site and global project implementation.You will provide...
-
Senior QA IT Specialist for Digital Transformation
vor 38 Minuten
Neuenburg, Neuenburg, Schweiz gloor&lang AG VollzeitJob OverviewThis is a highly rewarding opportunity to work as a Senior QA IT Specialist for Digital Transformation.You will be part of a globally renowned biopharmaceutical company, working on innovative projects that make a real difference in people's lives.Key Responsibilities:Leading Computerized System Validation (CSV) and validation activities.Ensuring...
-
Senior Manager QA
Vor 2 Tagen
Neuenburg, Neuenburg, Schweiz Gi Group SA VollzeitFor 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...
-
Senior Project Manager
Vor 2 Tagen
Neuenburg, Neuenburg, Schweiz nanoTRONIC VollzeitnanoTRONIC AG is a cutting-edge Swiss engineering company based in Lyss and Zürich Altstetten. Our expertise spans highly regulated industries, providing development services to internationally oriented clients.We specialize in sectors such as space, medical technology, and railways. Our core competences include building ground support equipment and...
-
Senior It Project Manager
Vor 4 Tagen
Neuenburg, Neuenburg, Schweiz Antaes Consulting SA VollzeitSenior Project Manager / Business Analyst – Tax Regulatory Projects, Wealth Management context Responsibilities: Lead IT projects related to the digital transformation of the production site. Oversee small to medium-sized projects, particularly the enhancement of the Manufacturing Execution System (MES – Emerson Syncade). Establish project governance...
-
Senior IT Project Manager
Vor 5 Tagen
Neuenburg, Neuenburg, Schweiz Antaes Consulting VollzeitRecruitment Business Partner at Antaes ConsultingSenior IT Project ManagerWorkload: 100%, on siteTo join our Life Sciences team in Neuchâtel, we are looking for a Senior IT Project Manager (F/M).The project:Lead IT projects related to the digital transformation of the production site.Oversee small to medium-sized projects, particularly the enhancement of...
-
Senior Project Manager
Vor 2 Tagen
Neuenburg, Neuenburg, Schweiz nanoTRONIC VollzeitnanoTRONIC AG is an innovative Swiss engineering company located in Lyss and Zürich Altstetten.Specializing in highly regulated industries, we are providing development services to internationally oriented customers.Our expertise spans sectors such as space, medical technology, and railways. Our core competences include building ground support equipment and...
-
Pharmaceutical Project Engineering Manager
vor 9 Stunden
Neuenburg, Neuenburg, Schweiz gloor&lang AG VollzeitJob Description:The role of the Senior Manager, Capital Project Engineering Pharma involves leading high-impact capital engineering projects from design to validation and startup. This includes collaborating with key stakeholders to ensure seamless project execution, managing financials to ensure cost-effective and compliant project outcomes, and overseeing...
-
QA IT MES Specialist
Vor 4 Tagen
Neuenburg, Neuenburg, Schweiz gloor&lang AG VollzeitJoint skills in QA and IT required French speaking jobJoin a Global Leader in Biopharmaceutical InnovationASAP | Initial Contract: 6 months (extension highly probable until end of 2025)As a QA IT MES Specialist, you will be at the forefront of ensuring excellence and compliance during the implementation of an electronic batch record system. With a strong...
-
Project Manager Capital Projects
Vor 3 Tagen
Neuenburg, Neuenburg, Schweiz Antaes Consulting VollzeitAt Antaes Consulting, we are seeking a highly skilled Senior Manager - Capital Project Engineering to join our team.About the Role:This is a leadership role that involves managing capital projects from start to finish, ensuring they are delivered on time, within budget, and to the required quality standards.The successful candidate will have a strong...
-
Pharmaceutical Project Engineering Manager
Vor 3 Tagen
Neuenburg, Neuenburg, Schweiz gloor&lang AG VollzeitJob OverviewGloor&lang AG seeks a highly experienced Senior Manager to lead capital engineering projects from design to validation and startup within the pharmaceutical industry.The ideal candidate will have a strong background in process safety management, process hazard analysis, and contract negotiation. They will be responsible for managing financials,...
-
Manager of Multidisciplinary Projects
Vor 4 Tagen
Neuenburg, Neuenburg, Schweiz Preciflex SA VollzeitWe are seeking a highly skilled and motivated Senior Project Manager to join our team at Preciflex SA.Role OverviewThis is an exciting opportunity to contribute to the development of innovative products and solutions in microengineering.ResponsibilitiesProduct Design: Develop innovative products that integrate mechanics and electronics.Project Execution:...
-
Project Manager
vor 2 Wochen
Neuenburg, Neuenburg, Schweiz CK Group VollzeitJob Title: Project Manager Technology Transfer Department: Global Operations / Technology TransferReports to: Director of Technology TransferCK QLS are working with a leading Global Pharmaceutical company, based in Neuchatel, Switzerland, to recruit a skilled Project Manager, to lead and manage technology transfer (TT) projects with a focus on Brazil,...
-
Senior Mechanical Project Lead
Vor 7 Tagen
Neuenburg, Neuenburg, Schweiz AL-AGEDI B. C. VollzeitAL-AGEDI B. C. is a leading engineering company seeking a Senior Mechanical Project Lead to manage our assembly machine projects. The successful candidate will be responsible for overseeing project execution, ensuring quality and safety standards, and maintaining strong relationships with clients and suppliers.Key Responsibilities:Lead project planning,...
-
Quality Assurance Manager
vor 9 Stunden
Neuenburg, Neuenburg, Schweiz gloor&lang AG VollzeitJob OverviewGloor&lang AG is seeking a highly experienced Quality Assurance Manager to join our team and support the implementation of complex CAPEX projects in the biopharmaceutical industry.About the RoleThis exciting opportunity will see you working closely with cross-functional teams to ensure the quality aspects of projects are managed efficiently and...
-
Manager of Capital Project Delivery
Vor 3 Tagen
Neuenburg, Neuenburg, Schweiz Antaes Consulting VollzeitWe are seeking a Senior Manager - Capital Project Engineering to lead our capital project delivery team.About the Company:Antaes Consulting is a leading consulting firm specializing in capital project delivery, with a strong focus on pharmaceutical manufacturing and biotechnology research.Main Responsibilities:Develop and implement project plans, timelines,...
-
Senior Leadership Role
Vor 3 Tagen
Neuenburg, Neuenburg, Schweiz Antaes Consulting VollzeitWe are looking for a Senior Manager - Capital Project Engineering to lead our capital project delivery team.About the Team:Our team is responsible for delivering complex capital projects across various industries, including biotechnology research, pharmaceutical manufacturing, and medical equipment manufacturing.Main Responsibilities:Develop and implement...
-
Senior Manager
Vor 4 Tagen
Neuenburg, Neuenburg, Schweiz Antaes Consulting VollzeitSenior Manager - Capital Project Engineering (F/M)Workload: 100%, on siteTo join our Life Sciences team in Neuchâtel, we are looking for a Senior Manager - Capital Project Engineering (F/M).The project:Leads the development of the capital project scope and objectives in support of the business strategy concerning clients and stakeholders. Experience in...