Senior Engineer, Manufacturing Compliance

Vor 3 Tagen


Couvet, Schweiz STA Pharmaceutical Switzerland SA Vollzeit
#slim #content {border: none;margin: 0;padding: 0;} #slim .slim_picture {text-align: left;margin: 0 10px 20px 0;} #slim .slim_picture img {max-height: 126px;} #slim .slim_content {border: none;} #slim .slim_title {font-size: 24px;font-weight: bold;margin: 0 0 10px 0;text-align: left;line-height: 32px;word-wrap: break-word;} #slim .slim_text {padding: 0 0 10px 0;} #slim p {margin-bottom: 16px;} #slim ul {padding-left: 16px;margin-left: 0;margin-top: 10px;margin-bottom: 10px;} #slim li {padding: 0;} #slim h1, #slim h2, #slim h3 {font-size: 12px;font-weight: normal;} #slim .slim_text a {font-weight: bold;color: #000;text-decoration: underline;} #slim .slim_text a:hover {font-weight: bold;color: #FF7500;text-decoration: underline;} #tjs24_root p {margin: 10px 0;} #tjs24_root ul {padding-left: 16px;margin-left: 0;margin-top: 10px;margin-bottom: 10px;font-size: 12px;} #tjs24_root div + ul {padding-top: 10px;} #slim .external-advert {outline: none;border: none;background: none;color: #0000FF;text-decoration: none;cursor: pointer;} #slim .external-advert:link {color: #0000FF;text-decoration: none;} #slim .external-advert:hover {color: #FF7500;text-decoration: underline;} #slim .external-advert:active {color: #FF7500;text-decoration: underline;} #slim .external-advert:visited {color: #0000FF;text-decoration: none;} #slim .bg-warning.external-advert a:link, #slim .bg-warning.external-advert a:hover, #slim .bg-warning.external-advert a:active, #slim .bg-warning.external-advert a:visited {text-decoration: none;color: #0458AB;} #slim .bg-warning.external-advert {background-color: #FFEEE0;} #slim .slim_content.mobile_content {border: none;padding: 0;overflow: hidden;} #slim .btn-primary a {color: #FFFFFF;} #slim .slim_content.mobile_content .external-iframe-hidden {display: none;height: 0;width: 0;position: absolute;} #content #job ul, #content #job ol {list-style: disc outside none;} Senior Engineer, Manufacturing ComplianceOverview

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 experience8 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 GAMPExperienced 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.

  • Couvet, Schweiz STA Pharmaceutical Switzerland SA Vollzeit

    OverviewThe 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...


  • Couvet, Schweiz WuXi AppTec Vollzeit

    The 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...


  • 2108 Couvet, Schweiz WuXi AppTec Vollzeit

    The 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...


  • 2108 Couvet, Schweiz WuXi AppTec Vollzeit

    The 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...


  • 2108 Couvet, Schweiz WuXi AppTec Vollzeit

    The 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...


  • Couvet, Schweiz STA Pharmaceutical Switzerland SA Vollzeit

    The Engineer, Manufacturing is involved in the new product introduction of oral solid dosage forms (capsules and tablets) in the site of Couvet. He/she is involved in all the technical activities related to manufacturing. He/she authors, owns and leads updates of GMP documents related to new product introduction for Bulk and/or Packaging Operations. He/she...


  • Couvet, Neuenburg, Schweiz STA Pharmaceutical Switzerland SA Vollzeit

    The Engineer, Manufacturing Role in Couvet SiteResponsibilities:Author and review manufacturing documentsKey contact for new product introduction topicsAct as a subject matter expert for customer inquiriesDevelop technical transfer plans in collaboration with departmentsTrain operational team on protocolsInitiate and lead investigations on deviationsLead...


  • Couvet, Neuenburg, Schweiz WuXi AppTec Vollzeit

    The Engineer, Manufacturing is involved in the new product introduction of oral solid dosage forms (capsules and tablets) in the site of Couvet. He/she is involved in all the technical activities related to manufacturing. He/she authors, owns and leads updates of GMP documents related to new product introduction for Bulk and/or Packaging Operations. He/she...


  • Couvet, Schweiz STA Pharmaceutical Switzerland SA Vollzeit

    #slim #content {border: none;margin: 0;padding: 0;} #slim .slim_picture {text-align: left;margin: 0 10px 20px 0;} #slim .slim_picture img {max-height: 126px;} #slim .slim_content {border: none;} #slim .slim_title {font-size: 24px;font-weight: bold;margin: 0 0 10px 0;text-align: left;line-height: 32px;word-wrap: break-word;} #slim .slim_text {padding: 0...


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

    The 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...


  • 2108 Couvet, Schweiz WuXi AppTec Vollzeit

    The Engineer, Manufacturing is involved in the new product introduction of oral solid dosage forms (capsules and tablets) in the site of Couvet. He/she is involved in all the technical activities related to manufacturing. He/she authors, owns and leads updates of GMP documents related to new product introduction for Bulk and/or Packaging Operations. He/she...


  • 2108 Couvet, Schweiz WuXi AppTec Vollzeit

    The Engineer, Manufacturing is involved in the new product introduction of oral solid dosage forms (capsules and tablets) in the site of Couvet. He/she is involved in all the technical activities related to manufacturing. He/she authors, owns and leads updates of GMP documents related to new product introduction for Bulk and/or Packaging Operations. He/she...


  • 2108 Couvet, Schweiz WuXi AppTec Vollzeit

    The Engineer, Manufacturing is involved in the new product introduction of oral solid dosage forms (capsules and tablets) in the site of Couvet. He/she is involved in all the technical activities related to manufacturing. He/she authors, owns and leads updates of GMP documents related to new product introduction for Bulk and/or Packaging Operations. He/she...


  • 2108 Couvet, Schweiz WuXi AppTec Vollzeit

    The Engineer, Manufacturing is involved in the new product introduction of oral solid dosage forms (capsules and tablets) in the site of Couvet. He/she is involved in all the technical activities related to manufacturing. He/she authors, owns and leads updates of GMP documents related to new product introduction for Bulk and/or Packaging Operations. He/she...


  • Couvet, Schweiz STA Pharmaceutical Switzerland SA Vollzeit

    ResponsibilitiesThe Manufacturing Engineer's main activities are completed autonomously for the following tasks and responsibilities: Author and review manufacturing (bulk/packaging) documents, including specifications, working practices, transfer protocol, master batch record, Forms and logbooks. Follow up approval flow within electronic documentations...


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

    The Engineer, Manufacturing is involved in the new product introduction of oral solid dosage forms (capsules and tablets) in the site of Couvet. He/she is involved in all the technical activities related to manufacturing. He/she authors, owns and leads updates of GMP documents related to new product introduction for Bulk and/or Packaging Operations. He/she...


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

    The Engineer, Manufacturing is involved in the new product introduction of oral solid dosage forms (capsules and tablets) in the site of Couvet. He/she is involved in all the technical activities related to manufacturing. He/she authors, owns and leads updates of GMP documents related to new product introduction for Bulk and/or Packaging Operations. He/she...


  • Couvet, Schweiz Wapt 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 the...


  • Couvet, Schweiz STA Pharmaceutical 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 the...


  • Couvet, Neuenburg, Schweiz STA Pharmaceutical 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 the highest...