![WuXi AppTec](https://media.trabajo.org/img/noimg.jpg)
Specialist, Manufacturing Compliance
vor 4 Wochen
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 metrics and acts as a referee for the operational team for GMP systems, documentation and training. He/she is the manufacturing referee for the batch record creation and revision in PAS-X electronic system.
*** This is a Long-Term Temporary Position**
- Initiate deviations and participate to or lead on the floor investigations. Partner with QA and Packaging or Bulk Operations to ensure assessments and investigations are exhaustive.
- Follow up and implement assigned CAPA's.
- Author and review manufacturing (bulk/packaging) documents, including specifications, working practices, Forms and logbooks. Follow up approval flow within electronic documentations system and facilitate all stakeholders input to ensure documents are updated and approved in a timely manner.
- Lead risk assessments and risk management cross functional teams (from draft to approval).
- Act as manufacturing referee for the batch record creation and revision in PAS-X electronic system: provide the manufacrturing input, perform the required testing and manufacturing execution to support batch record testing and qualification. Review and approve the batch record and associated Parameters value list (PVL) in Pas_X system.
- Perform complaint investigations linked to Manufacturing.
- Initiate, own, and follow up change controls related to manufacturing (bulk/packaging). Manage stakeholders involved.
- Contribute to continuous improvement, including proactively identifying problems, gathering input from the operational team and proposing solutions.
- Participate to or lead projects and initiatives as directed by the Head of manufacturing (bulk/ packaging Operations.
- Act as quality system and GMP Documentation referee for the manufacturing (bulk/packaging Ops Team and as a key Bulk/Packaging team representative for QA Ops.
- Support the Head of Packaging Operations in proactively monitoring Quality and performance metrics and in proposing improvement measures.
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 French and English
-
Specialist, Manufacturing Compliance
vor 1 Monat
2108 Couvet, Schweiz WuXi AppTec VollzeitThe 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...
-
Specialist, Manufacturing Compliance
vor 4 Wochen
2108 Couvet, Schweiz WuXi AppTec VollzeitThe 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...
-
Specialist, Manufacturing Compliance
vor 4 Wochen
Couvet, Schweiz WuXi AppTec VollzeitThe 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...
-
Specialist, Manufacturing Compliance
vor 1 Woche
Couvet, Schweiz WuXi AppTec VollzeitThe 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...
-
Specialist, Manufacturing Compliance.
vor 3 Wochen
Couvet, Val-de-Travers, NE, Schweiz WuXi AppTec VollzeitThe 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...
-
Manager Bulk Operations Manufacturing
vor 3 Wochen
2108 Couvet, Schweiz WuXi AppTec VollzeitThis 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...
-
Senior Engineer, Manufacturing Compliance
Vor 3 Tagen
Couvet, Schweiz STA Pharmaceutical Switzerland SA VollzeitOverviewThe 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...
-
Manager Bulk Operations Manufacturing
vor 3 Wochen
2108 Couvet, Schweiz WuXi AppTec VollzeitThis 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...
-
Manager Bulk Operations Manufacturing
vor 3 Wochen
2108 Couvet, Schweiz WuXi AppTec VollzeitThis 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...
-
Manager Bulk Operations Manufacturing
vor 4 Wochen
Couvet, Schweiz Wapt VollzeitOverview: 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...
-
Manager Bulk Operations Manufacturing
vor 3 Wochen
Couvet, Schweiz STA Pharmaceutical VollzeitOverview: 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...
-
Manager Bulk Operations Manufacturing
Vor 2 Tagen
Couvet, Schweiz Wapt VollzeitOverview: 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...
-
Manager Bulk Operations Manufacturing
vor 1 Woche
Couvet, Neuenburg, Schweiz STA Pharmaceutical VollzeitOverview: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...
-
Manager Bulk Operations Manufacturing
vor 1 Woche
Couvet, Schweiz WuXi AppTec VollzeitThis 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...
-
Manager Bulk Operations Manufacturing
Vor 3 Tagen
Couvet, Schweiz STA Pharmaceutical Switzerland SA VollzeitOverviewThis 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...
-
Associate Specialist QA Operations
vor 2 Wochen
2108 Couvet, Schweiz WuXi AppTec VollzeitQA 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 relationships with QA...
-
Head of Production
vor 3 Wochen
2108 Couvet, Schweiz WuXi AppTec VollzeitThis 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...
-
Manager QC Analytical Science
vor 4 Wochen
2108 Couvet, Schweiz WuXi AppTec VollzeitQuality Control is responsible to support the entire Couvet site to ensure that each analytical and microbiological testing is performed in compliance with the site’s Quality Management Systems (QMS), the cGMP, the applicable laws, regulations, and standards, and in compliance with the Product’s Dossier managed by the Customer. The position holder is...
-
Manager QC Analytical Science
vor 4 Wochen
2108 Couvet, Schweiz WuXi AppTec VollzeitQuality Control is responsible to support the entire Couvet site to ensure that each analytical and microbiological testing is performed in compliance with the site’s Quality Management Systems (QMS), the cGMP, the applicable laws, regulations, and standards, and in compliance with the Product’s Dossier managed by the Customer. The position holder is...
-
Manager QC Analytical Science
vor 4 Wochen
2108 Couvet, Schweiz WuXi AppTec VollzeitQuality Control is responsible to support the entire Couvet site to ensure that each analytical and microbiological testing is performed in compliance with the site’s Quality Management Systems (QMS), the cGMP, the applicable laws, regulations, and standards, and in compliance with the Product’s Dossier managed by the Customer. The position holder is...