Senior Manager QA/RA Projects Lead
vor 2 Monaten
This position is a safeguard and role model for the WuXi values and competencies, ensuring the entire Couvet site adheres to regulatory requirements and maintains high-quality standards.
Key Responsibilities- Act as the deputy of the Responsible Person (RP) according to Art. 5 and Art. 17 of the Swiss Ordinance on Establishment Licenses (SR) and the Qualified Person according to Annex 16 of the EU Guide to Good Manufacturing Practice for the Couvet site.
- Represent the site's quality assurance and regulatory affairs in key projects teams, serving as the single point of contact for QA, Compliance, Quality Supplier, and Regulatory Affairs.
- Coordinate and drive quality activities related to technology transfer, analytical transfer, raw materials introduction, supplier qualification, manufacturing specifications, and CMC dossier setup.
- Conduct assessments of change controls for site-related projects and/or product life-cycle projects with relevant quality SMEs and act as the site interface with Global Regulatory (CMC & Affairs).
- Support responses to regulatory authorities' requests, such as submissions or periodic GMP reviews, and review regulatory authorities' citations provided to other sites.
- Actively support site quality activities, including multi-site investigations, change controls, review of MBR and executed batch records related to NPI, internal audits, health authority and client inspections, and continuous improvement.
- Ensure compliance with the policy of security at work and laws concerning health and security of workers within the area of responsibility.
- Work closely with EHS to evaluate hazards and perform risk analysis, promote safe practices and behaviors, and verify that EHS rules are implemented and followed.
- Release of batches as RP deputy.
- Close out of Critical Complaints.
- Approval of Complaints Extension Requests when an escalated approval is required.
- Approval of Investigation Reports/Notifications sent to Health Authorities related to Complaints.
- Approval of Master Batch records.
- Approval of documentations related to Suppliers/CSPs qualification and maintenance activities.
- APR/PQR approval.
- At least 7 years of experience in Quality Assurance, Quality Control, and/or Regulatory Affairs in a pharmaceutical company or other related industry.
- Bachelor's degree in Pharmacy, Chemistry, Microbiology, or related science.
- Thorough understanding of cGMPs and Swiss, EU, and FDA regulatory requirements.
- Demonstrated experience in Regulatory strategies and tactics.
- Strong knowledge of all phases from the global drug development process and clinical trial data flow up to analytical/technology transfer to manufacturing/testing site and product launches.
- Solid understanding of Oral Solid Dosage form manufacturing, packaging, testing, warehousing processes, validation, and registration.
- Strategic thinking, business acumen, holistic approach, leading vision, innovation management, and negotiation.
- Excellent interpersonal, collaborative, and organizational skills.
- Strong communication skills, ability to communicate effectively to management, functional groups, broader organization, and executives.
- High credibility and reliability.
- Excellent investigational and QA problem-solving skills.
- Ability to interpret complex situations with a degree of independence and to articulate recommendations for resolution.
- Drives continuous improvement.
- Knowledge of most common office software and of IT-principles.
-
Senior Manager QA/RA Projects Lead
vor 2 Monaten
La Brévine NE, Schweiz WuXi AppTec VollzeitJob SummaryThis position is a safeguard and role model for the WuXi values and competencies, ensuring the entire Couvet site adheres to regulatory requirements and maintains high-quality standards.Key ResponsibilitiesAct as the deputy of the Responsible Person (RP) according to Art. 5 and Art. 17 of the Swiss Ordinance on Establishment Licenses (SR) and the...
-
Senior Manager QA/RA Projects Lead
vor 2 Monaten
La Brévine NE, Schweiz WuXi AppTec VollzeitJob SummaryThis position is a safeguard and role model for the WuXi values and competencies, ensuring the highest standards of quality and regulatory compliance.Key ResponsibilitiesAct as the deputy of the Responsible Person (RP) according to Art. 5, and Art. 17 of the Swiss Ordinance on Establishment Licenses (SR and of the Qualified Person according to...
-
Senior Manager QA/RA Projects Lead
vor 2 Monaten
La Brévine NE, Schweiz WuXi AppTec VollzeitJob SummaryThis position is a safeguard and role model for the WuXi values and competencies, ensuring the entire Couvet site adheres to the Marketing Authorisation Dossier managed by the Customer/Product Owner and supports the site in Company Regulatory Surveillance initiatives.Key ResponsibilitiesAct as the deputy of the Responsible Person (RP) according to...
-
Senior Manager QA/RA Projects Lead
vor 2 Monaten
La Brévine NE, Schweiz WuXi AppTec VollzeitJob SummaryThis position is a safeguard and role model for the WuXi values and competencies, ensuring the highest standards of quality and regulatory compliance in all aspects of pharmaceutical manufacturing.Key ResponsibilitiesAct as the deputy of the Responsible Person (RP) according to Art. 5, and Art. 17 of the Swiss Ordinance on Establishment Licenses...
-
Project Manager-bu Position Sensors
vor 2 Monaten
La Grande Béroche, NE, Schweiz Melexis Microelectronic Systems VollzeitYOUR FUTURE JOB As a Project Manager at Melexis, you will steer every aspect of IC development, from inception to mass production. Your mission? to successfully meet Melexis’ ambitious technical, commercial and quality objectives and provide our customers with leading-edge, innovative solutions. More specifically, you will: - Take charge of initiating...
-
Sourcing Manager, R&D projects Lead
vor 2 Wochen
La Plaine, Schweiz dsm-firmenich VollzeitAbout the RoleWe are looking for a highly motivated and driven Sourcing Manager, R&D projects to join our team at dsm-firmenich.As a Sourcing Manager, you will be responsible for scouting, sourcing, sampling, and introducing new raw materials (RMs) for fragrance and flavor ingredients in development or optimization phase.Key Responsibilities:Boost...
-
Application Project Leader
vor 3 Wochen
Môtiers NE, Schweiz ETEL VollzeitMôtiers (Switzerland) 100% ETEL is a worldwide leader in the development and manufacturing of high-performance motion control components and high-end mechatronic motion systems based in Môtiers, and 100% dedicated to direct drive solutions. We currently call upon a growing diversity of skills which take part in the exciting adventure of our...
-
Application project LEADER-ENGINEER
vor 3 Monaten
Môtiers NE, Schweiz ETEL S.A. VollzeitETEL worldwide leader in the development and manufacturing of high performance motion control components and high-end mechatronic motion systems based in Môtiers, and 100% dedicated to direct drive solutions. We currently call upon a growing diversity of skills which take part in the exciting adventure of our international activity. Contribute to our...
-
Ic Design Manager
vor 2 Monaten
La Grande Béroche, NE, Schweiz Melexis Microelectronic Systems VollzeitYOUR FUTURE JOB As IC Design Manager at Melexis, you ensure that all people management processes and related practices are professionally implemented with a special emphasis in optimizing the learning through developing and coaching the team members in their assigned projects.The team consists of Analog Design, Mixed-Signal Design, Layout and Product...
-
Project Manager-BU Position Sensors
vor 3 Wochen
La Grande-Béroche, Schweiz Melexis Microelectronic Systems VollzeitYOUR FUTURE JOB As a Project Manager at Melexis, you will steer every aspect of IC development, from inception to mass production. Your mission? to successfully meet Melexis’ ambitious technical, commercial and quality objectives and provide our customers with leading-edge, innovative solutions. More specifically, you will: Take charge of...
-
Sourcing Manager, R&D Projects
vor 4 Wochen
La Plaine, Schweiz dsm-firmenich VollzeitAbout the RoleWe are seeking a highly motivated and driven Sourcing Manager to join our R&D team in Geneva, Switzerland. As a key member of our Creation Hub Europe, you will be responsible for sourcing and procuring high-quality raw materials for our fragrance and flavor ingredients.Key ResponsibilitiesScout, source, sample, and introduce new raw materials...
-
Commercial Manager
vor 5 Monaten
La Tour-de-Peilz, Schweiz Nestle Operational Services Worldwide SA Vollzeit**Position Snapshot** - Location: La-Tour-de-Peilz, Switzerland - Company: NESA Business Growth Solution - Act. Rate: Full-Time 100 % - Type of contract: Permanent contract - Genuine opportunities for career development, training and personal development. - Attractive and dynamic international working environment. - Modern “smart office” locations...
-
Quality Assurance Expert
vor 2 Monaten
Neuenburg, NE, Schweiz Takeda Pharmaceutical VollzeitTakeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism - Integrity, Fairness, Honesty, and Perseverance - and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading...
-
Application project LEADER-ENGINEER
vor 3 Monaten
Môtiers NE, Schweiz ETEL S.A. VollzeitWe are looking for An autonomous and proactive person, well organized with excellent communication skills. An employee who has the willingness to become a technical expert in new products / applications with customer focus. We offer you A challenging position in an open and dynamic midsize employer within an international environment Competitive...
-
Project Manager
vor 2 Wochen
Neuchâtel NE, Schweiz IMA Automation Switzerland SA VollzeitPoste à pourvoir sur nos sites de Gals et Boudry. IMA Group est un des leaders mondiaux de la conception et de la fabrication de machines automatiques pour le traitement et le conditionnement de produits pharmaceutiques, alimentaires et d'automation en général. Il compte 6200 collaborateurs dans le monde. IMA Automation Switzerland SA , membre de la...
-
Technical Design Manager
vor 1 Monat
La Tène, Schweiz Swatch Group VollzeitThe company EM, an award-winning semiconductor company, developing and manufacturing the world's leading ultra low power technology platforms, is looking for a Technical Design Manager to lead its next-generation IoT system-on-chip (SoC) platform design and implementation activities, and drive methodology, EDA tools and technology roadmap. Job...
-
Sourcing Manager, R&D Projects Specialist
vor 1 Monat
La Plaine, Schweiz dsm-firmenich VollzeitAbout the RoleWe are seeking a highly motivated and driven Sourcing Manager, R&D Projects to join our team at dsm-firmenich. As a key member of our Research and Development department, you will be responsible for sourcing and procuring new raw materials, fine chemicals, and innovative solutions for our fragrance and flavor ingredients.Key...
-
Sourcing Manager, R&D Projects Specialist
vor 3 Wochen
La Plaine, Schweiz dsm-firmenich VollzeitAbout the RoleWe are seeking a highly motivated and driven Sourcing Manager, R&D Projects to join our team at dsm-firmenich. As a key member of our Creation Hub Europe, you will play a crucial role in the client's project development cycle.Key ResponsibilitiesBoost competitivity & performance by scouting, sourcing, sampling, and introducing new raw materials...
-
Application Project Leader-Engineer
vor 1 Monat
2112 Môtiers NE, Schweiz ETEL S.A. VollzeitWe are looking forAn autonomous and proactive person, well organized with excellent communication skills. An employee who has the willingness to become a technical expert in new products / applications with customer focus. We offer youA challenging position in an open and dynamic midsize employer within an international environmentCompetitive compensation &...
-
Application Project Leader-Engineer
vor 3 Wochen
2112 Môtiers NE, Schweiz ETEL S.A. VollzeitWe are looking forAn autonomous and proactive person, well organized with excellent communication skills. An employee who has the willingness to become a technical expert in new products / applications with customer focus. We offer youA challenging position in an open and dynamic midsize employer within an international environmentCompetitive compensation &...
