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L'Operator I Packaging Operations aura pour mission d'assurer les activites de conditionnement des produits (blister, bouteille, etui, wallet, inspection visuelle), dans le respect de la reglementation BPF / cGMPs, des regles d'hygiene, et de securite. II devra se conformer aux procedures definies par le systeme qualite du site pharmaceutique.
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 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:
This position is responsible to perform all type of analytical testing that is required for release of raw and packaging materials, final product and stability samples as well as all IPC testing. Additional responsibilities can be the support of stability studies, handling of deviations and change controls.
As a QC team member, the person filling this position supports all activities to continuously maintain the GMP status of the QC Laboratory.
This position is responsible to perform all type of analytical testing that is required for release of raw and packaging materials, final product and stability samples as well as all IPC testing. Additional responsibilities can be the support of stability studies, handling of deviations and change controls.
As a QC team member, the person filling this position supports all activities to continuously maintain the GMP status of the QC Laboratory.
The Engineer, Engineering is involved in the introduction of new equipment for oral solid dosage forms (capsules and tablets), as part of the Darwin site expansion project, in the site of Couvet..
He/she is involved in all the technical activities related to engineering/ qualification. He/she authors, owns and leads updates of GMP documents related to new equipment introduction for Bulk and/or Packaging Operations. He/she trains the operational teams to the protocol/master batch record for the new equipment.
The incumbent will uncover and cultivate business relationships and opportunities to generate revenue with prospective and existing clients for WuXi Tides and STA Pharmaceutical, a WuXi AppTec company, in particular to support the growth of emerging oligo and peptide (O&P) Contract Development and Manufacture (CDMO) business. The candidate will work within the US business development (BD) team to pursue new business leads; follows up on critical issues and aid in resolving customer inquiries. Assists marketing in raising the profile of WuXi Tides within US.
The incumbent will uncover and cultivate business relationships and opportunities to generate revenue with prospective and existing clients for WuXi Tides and STA Pharmaceutical, a WuXi AppTec company, in particular to support the growth of emerging oligo and peptide (O&P) Contract Development and Manufacture (CDMO) business. The candidate will work within the US business development (BD) team to pursue new business leads; follows up on critical issues and aid in resolving customer inquiries. Assists marketing in raising the profile of WuXi Tides within Europe.
WuXi TIDES, a leading Contract Research and Development Manufacturing Organization (CRDMO), is an integral part of the WuXi AppTec’s subsidiary WuXi STA. WuXi TIDES offers our worldwide partners efficient, flexible, and high-quality solutions for the drug development of oligonucleotides, peptides and related synthetic conjugates (“TIDES” drug). We greatly simplify the TIDES drug development by providing all discovery, CMC development and the entire manufacturing supply chain under one roof.
(Senior) Director of Quality Assurance (STA Qualified Person (QP))
Location: Germany, Munich, but willingness to travel and stay at WuXi STA Couvet, Switzerland site.
Le Technician Bulk Operations aura pour mission d’assurer les activités de fabrication des produits (capsules ou comprimés), dans le respect de la réglementation BPF / cGMPs, des règles d’hygiène, et de sécurité. Il devra se conformer aux procédures définies par le système qualité du site pharmaceutique.
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 relationships with QA departments at contract facilities. The position will support on the floor QA activities (deviation, CAPA, OOS, change control, batch release, archiving, complaints …) Couvet site included work in 2*8 shift if...
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 late clinical stage and commercial OSD projects will help you successfully oversee multiple projects in parallel.
WuXi STA (stapharma.com), a subsidiary of WuXi AppTec, is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with global operations across Asia, North America, and Europe. As a premier Contract Research, Development, and Manufacturing Organization (CRDMO), WuXi STA offers its worldwide partners efficient, flexible and high-quality solutions for integrated chemical, manufacturing and controls (CMC) from preclinical to commercial uses.
WuXi TIDES is an integral...
We are seeking a highly skilled and dynamic individual to join our team as a Technical Content Director. The successful candidate will play a crucial role in bridging technical expertise with marketing initiatives to showcase WuXi STA's strengths in the industry.
Job Summary:
Le Technician Bulk Operations aura pour mission d’assurer les activités de fabrication des produits (capsules ou comprimés), dans le respect de la réglementation BPF / cGMPs, des règles d’hygiène, et de sécurité. Il devra se conformer aux procédures définies par le système qualité du site pharmaceutique.
The Project Manager II will manage and coordinate clinical and/or data project services for sponsors to assure project/program milestones are met according to contract and applicable regulations are followed. Preference for in-office over work from home with occasional travel depending on project.
WuXi Clinical, a wholly owned subsidiary of WuXi AppTec, is a global Contract Research Organization (CRO) providing a comprehensive range of services in clinical development. We provide Phase I to Phase IV clinical development services & BE (Bioequivalence), for products including pharmaceuticals, biologics, and medical devices. With expertise spanning all major therapeutic areas, we deliver the unique blend of an experienced team, combined with the creativity, responsiveness, and customer centric-focus of a highly nimble organization. This forward-thinking approach has allowed us to work on a variety of projects ranging from first-in-human products to marketed drugs and devices.
WuXi Clinical, a wholly owned subsidiary of WuXi AppTec, is a global Contract Research Organization (CRO) providing a comprehensive range of services in clinical development. We provide Phase I to Phase IV clinical development services & BE (Bioequivalence), for products including pharmaceuticals, biologics, and medical devices. With expertise spanning all major therapeutic areas, we deliver the unique blend of an experienced team, combined with the creativity, responsiveness, and customer centric-focus of a highly nimble organization. This forward-thinking approach has allowed us to work on a variety of projects ranging from first-in-human products to marketed drugs and devices.
STA Pharmaceutical Co., Ltd., a WuXi AppTec company (WuXi STA), is a global leading small molecule pharmaceutical development and manufacturing capability and technology platform company serving the life science industry, with operations in China and the United States. As a premier Contract Development and Manufacturing Organization (CDMO), STA offers our worldwide partners efficient, flexible and high-quality solutions for small molecule Active Pharmaceutical Ingredients (APIs) and finished dosage forms.
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