Senior Engineer, Manufacturing Compliance
Vor 3 Tagen
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.
QualificationsExperience / 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.
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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...
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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...
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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...
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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
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
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...
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Engineer, Manufacturing
vor 4 Wochen
Couvet, Schweiz STA Pharmaceutical Switzerland SA VollzeitThe 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...
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Engineer, Manufacturing
vor 4 Wochen
Couvet, Schweiz STA Pharmaceutical Switzerland SA VollzeitThe 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...
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Engineer, Manufacturing
vor 2 Wochen
Couvet, Neuenburg, Schweiz STA Pharmaceutical Switzerland SA VollzeitThe 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...
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Engineer, Manufacturing
vor 1 Woche
Couvet, Neuenburg, Schweiz WuXi AppTec VollzeitThe 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...
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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...
-
Engineer, Manufacturing
vor 3 Wochen
2108 Couvet, Schweiz WuXi AppTec VollzeitThe 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...
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Engineer, Manufacturing
vor 3 Wochen
2108 Couvet, Schweiz WuXi AppTec VollzeitThe 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...
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Engineer, Manufacturing
vor 3 Wochen
2108 Couvet, Schweiz WuXi AppTec VollzeitThe 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...
-
Engineer, Manufacturing
vor 3 Wochen
2108 Couvet, Schweiz WuXi AppTec VollzeitThe 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...
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Engineer, Manufacturing
Vor 3 Tagen
Couvet, Schweiz STA Pharmaceutical Switzerland SA VollzeitResponsibilitiesThe 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...
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Engineer, Manufacturing.
vor 3 Wochen
Couvet, Val-de-Travers, NE, Schweiz WuXi AppTec VollzeitThe 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...
-
Engineer, Manufacturing.
vor 3 Wochen
Couvet, Val-de-Travers, NE, Schweiz WuXi AppTec VollzeitThe 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...
