Senior Engineer, Manufacturing Compliance

vor 3 Monaten


ValdeTravers, Schweiz WuXi AppTec Vollzeit

Overview

The Senior Engineer, Manufacturing Compliance authors, owns and leads updates of GMP documents related to Bulk and/or Packaging Operations. He/she initiates and owns deviations related to Bulk and/or Packaging Operations and leads investigation tasks as required. He/she supports the Head of Bulk and/ or Packaging Operations in monitoring quality and performance metrics and acts as a referee for the operational team for GMP systems, documentation and training. He/she acts as deputy to the Head of Bulk and/or Packaging.

Qualifications

Experience / Education

BS/MS in Engineering/Technical discipline or equivalent experience 8 years' experience in pharmaceutical validation, packaging or related field

Knowledge / Skills / Abilities:

Sound knowledge of current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines and GAMP Experienced in Health Authority inspections (preparation, process, presentations, responses drafting, etc). Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems and processes. Well-developed ability to constructively work across functional areas and levels to achieve results, Strong verbal and written communication skills, Strong analytical, problem solving, influential and deductive skills, Capability to work with short deadlines and simultaneous activities, Excellent organizational and project management skills, Successful experience in direct people management, Fluent in English and in French.

  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Job SummaryThe Senior Compliance Engineer will be responsible for authoring, owning, and leading updates of Good Manufacturing Practice (GMP) documents related to Bulk and/or Packaging Operations at WuXi AppTec. This individual will initiate and own deviations related to Bulk and/or Packaging Operations and lead investigation tasks as required.Key...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    About the RoleThe Senior Engineer, Manufacturing Compliance will be responsible for authoring, owning, and leading updates of GMP documents related to Bulk and/or Packaging Operations. This individual will initiate and own deviations related to Bulk and/or Packaging Operations and lead investigation tasks as required. They will support the Head of Bulk...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Job Title: Senior Project ManagerThis position plays a critical role in ensuring the quality and compliance of our pharmaceutical products at the Couvet site. As a member of the Quality Leadership Team, the successful candidate will collaborate with other team members to maintain and improve quality systems, ensuring timely resolution of any compliance...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Job Title: Senior Project ManagerThis position plays a critical role in ensuring the quality and compliance of our pharmaceutical products at the Couvet site. As a Senior Project Manager, you will be responsible for supporting the site in maintaining and improving quality systems, ensuring compliance with regulatory requirements, and collaborating with the...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Job Title: Senior Project ManagerThis position plays a critical role in ensuring the quality and compliance of our pharmaceutical products at the Couvet site. As a member of the Quality Leadership Team, the successful candidate will collaborate with other team members to maintain and improve quality systems, ensuring timely resolution of any cGMP compliance...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Job Title: Senior Project ManagerThis position plays a critical role in ensuring the quality and compliance of our pharmaceutical products at the Couvet site. As a member of the Quality Leadership Team, the successful candidate will collaborate with other team members to maintain and improve quality systems, ensuring timely resolution of any cGMP compliance...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Senior Project ManagerThis position plays a critical role in ensuring the quality and compliance of our pharmaceutical products at the Couvet site. As a key member of the Quality Leadership Team, you will collaborate with other team members to maintain and improve quality systems, address cGMP compliance issues, and act as the main quality representative for...


  • Val-de-Travers, Schweiz WuXi AppTec Vollzeit

    Overview This position is a leadership role being responsible in direct management of individual contributors and/or supervisors and/or managers. This position is a safeguard and role model for the WuXi values and competencies. Job Summary: Lead the bulk operations and ensure that packaging goods are produced according to supply needs and as per...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Job SummaryThis role is a leadership position responsible for the direct management of individual contributors and/or supervisors and/or managers. As a key player in the product manufacturing process, this position will work closely with QA, QC, production, and logistics departments to ensure the highest standards of quality and health & safety are met.Key...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Job Title: Senior Project ManagerThis position plays a critical role in ensuring the quality and compliance of our pharmaceutical products at the Couvet site. As a member of the Quality Leadership Team, the successful candidate will collaborate with other team members to maintain and improve quality systems, ensuring timely resolution of any compliance...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Senior Project ManagerThis position plays a pivotal role in ensuring the seamless execution of projects at the Couvet site, guaranteeing that each product adheres to the Marketing Authorisation Dossier managed by the Customer/Product Owner. Additionally, the position supports the site in Company Regulatory Surveillance initiatives.As a key member of the...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Senior Project ManagerThis position plays a pivotal role in ensuring the seamless execution of projects at the Couvet site, guaranteeing that each product adheres to the Marketing Authorisation Dossier managed by the Customer/Product Owner. Additionally, the position supports the site in Company Regulatory Surveillance initiatives.As a key member of the...


  • Val-de-travers, Schweiz WuXi AppTec Vollzeit

    This position is responsible to support the entire Couvet site to 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..As a member of the Quality Leadership Team,...


  • Travers, Val-de-Travers, NE, Schweiz WuXi AppTec Vollzeit

    This position is a safeguard and role model for the WuXi values and competencies.   Job Summary: This position is responsible to support the entire Couvet site to 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...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Job SummaryThis position is a safeguard and role model for the WuXi values and competencies. As a key member of the Quality Leadership Team, the position holder is responsible for ensuring that the entire Couvet site operates in compliance with regulatory requirements and company policies.Key ResponsibilitiesAct as the deputy of the Responsible Person (RP)...


  • Val-de-ruz, Schweiz WuXi AppTec Vollzeit

    This position is a safeguard and role model for the Wu Xi values and competencies. Job Summary: This position is responsible to support the entire Couvet site to 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...


  • Val-de-Travers, Schweiz WuXi AppTec Vollzeit

    Overview QA Operations Team is committed to actively support the Couvet site and other departments to ensure cGMP compliant processes and products. This position is responsible for quality assurance (QA) involved primarily with the review of bulk or packaged commercial drug products, raw material batches if required and maintaining working...


  • Val-de-Travers, Schweiz WuXi AppTec Vollzeit

    Overview This position is accountable for all New Product Introductions at the site of Couvet, Switzerland. This includes leading the Manufacturing, Science and Technology, MS&T team. The site is currently expanding its capabilities and capacities, and there are future expansions planned. Your strong technical knowledge and experience of transferring...


  • Val-de-Travers, Schweiz WuXi AppTec Vollzeit

    Overview This position is a key leadership role being responsible for the direct management of individual contributors, supervisors and managers. This position is a role model for the WuXi values and competencies. Job Summary: The Associate Director Quality Contro l is charged with Overseeing the Quality Control department, this position...


  • La Chaux-de-Fonds, Schweiz Breitling Vollzeit

    **We are a Squad on a mission to redefine timekeeping since 1884. Crafting watches that excel from air to land and sea, we embrace a unique blend of casual, sustainable, and inclusive luxury. Celebrating 140 years of history, with over 1900 passionate people over 20 countries, we're seeking exceptional talent to join our Squad in La Chaux-De-Fonds as an...