Quality Assurance Specialist 100%
vor 3 Wochen
Accountabilities
- Ensure qualification of corporate suppliers and subcontractors (API/ IP suppliers, Contract Manufacturers, service providers, etc.)
- Performance of audits
- Establishment of Quality and technical agreements (writing and implementation)
- Execute of quality risk assessment process in a timely manner
- Ensure adherence of suppliers and contract manufacturers to corporate policies/procedures, regulatory MAs, applicable Quality and Technical agreements and applicable US and EU regulations such as those of Pharmaceuticals, Food Supplements and medical devices.
- Provide quality oversight of day to day operations performed at API/ IP suppliers and Contract Manufacturers organization (CMO).
- Review and approval of GMP documentation (CMO Master Batch Records, CMO process validation protocols and reports, CMO stability studies protocols and reports, etc.).
- Review of CMO batch documentation for Stragen or customer release.
- Review and approval of change requests.
- Review and approval of PQRs.
- Management of deviations: Perform and document investigations according to internal procedures
- Management of complaints: Perform and document investigations according to internal procedures
- Management of CAPA: Establish and implement corrective and preventive actions according to internal procedures
- Management of product changeover: Perform, document and coordinate the implementation of change controls
- Management of Quality Risk Assessment : evaluate, control, communicate and review the risk according to internal procedures
- Execute alert and batch recall process
- Provide status reports, including relevant metrics, to HOD QA Operations; actively contributing to QA Operations department and Stragen goals and objectives
- Represents and act as QA Operational in the Product Launch team
- Represent Stragen Quality Assurance including face to face visits, internal/external audits, and Quality Review Meetings
- Support Quality Operations in internal/external audits and regulatory inspections.
- Provide support to customers for QA Operations topics
- Manage own time to carry out assigned duties that support business goals.
- Works as a resource to identify process issues and execute implementation of CAPA in a timely manner to ensure customer commitments are met
- Perform all other duties assigned by the Head of Department / the management
Personal core competencies
- Creativity in problem solving skills
- Good negotiation skills with customer-oriented attitude
- Excellent organizational skills
- Able to prioritize, assess urgency and set deadlines
- Able to manage multiple tasks simultaneously
- Able to establish collaborative relationships
- Able to demonstrate independence, objectivity and ethics
- Able to apply good judgement and good appreciation of quality issues
- Able to work under pressure
- Attentive to details
Skills
- Fluent in English, both written and spoken
- Knowledge of quality management standards / regulations
- Scientific background
- Solid knowledge of GMP and GDP
Qualifications / Prerequisites
- Scientific university degree
- At least 5 years of experience in a Quality Assurance department of a pharmaceutical company
- Experience working in close collaboration with customers & subcontractors
-
Conseiller en assurances
vor 2 Wochen
Plan-les-Ouates, Schweiz Cs Conseils VollzeitCS conseils est une société basée à Plan les Ouates dans le canton de Genève, spécialisée dans le conseil en assurance et en prévoyance pour les Suisses et Frontaliers.Dans le cadre de son développement, nous recherchons une ou un conseiller en assurance afin d'étoffer l'équipe...
-
Pharmacien Assurance Qualité Opérationelle
Vor 3 Tagen
Plan-les-Ouates, Schweiz Approach people VollzeitSous la responsabilité du Responsable Qualité Opérationnelle Injectables, vous mettez en oeuvre les systèmes qualité permettant au site de satisfaire aux directives du Groupe, aux exigences des cGMP et autres réglementations nécessaires pour servir le client en qualité, dans les délais et pour garantir la réussite des inspections et...
-
Risk, Compliance
vor 1 Monat
Plan-les-Ouates, Schweiz Richemont VollzeitRISK, COMPLIANCE & NON-FINANCIAL REPORTING SPECIALIST Plan-les-Ouates, Geneva, Switzerland Fixed Term 12 months Through our universe, our collaborators from different horizons share a common objective: the ongoing quest for excellence driven by the outstanding abilities and commitment of the women and men who work in our Maison. As a House of...
-
Junior Data Scientist
Vor 4 Tagen
Plan-les-Ouates, Schweiz Richemont VollzeitReference Code: 100027**Junior Data Scientist**: - Richemont- Plan-Les-Ouates, GE, CH- Fixed Term- Richemont owns some of the world’s leading luxury goods Maisons, with particular strengths in jewellery, fine watches and premium accessories. Each Maison represents a proud tradition of style, quality and craftsmanship and Richemont seeks to preserve the...
-
Technician, Dowsnstream Manufacturing
Vor 6 Tagen
Plan-les-Ouates, Schweiz KBI Biopharma VollzeitJob summary Responsible for technical activities for GMP Manufacturing Operations in a multi-products biopharmaceutical facility. This position includes supporting safety, compliance, quality, scheduling, production record generation and revision, production process execution, equipment onboarding, process improvement projects ownership and manufacturing...
-
Technician Downstream Manufacturing
Vor 3 Tagen
Plan-les-Ouates, Schweiz KBI Biopharma VollzeitThis position will be a 5-month mission via an agency. Job summary Responsible for technical activities for GMP Manufacturing Operations in a multi-products biopharmaceutical facility. This position includes supporting safety, compliance, quality, scheduling, production record generation and revision, production process execution, equipment onboarding,...
-
Assistant(E) RH Fr
Vor 4 Tagen
Plan-les-Ouates, Schweiz Smood VollzeitSmood est un des leaders des services de livraison en Suisse. Notre objectif est d'améliorer la vie des citoyens dans tout ce que nous faisons. Smood est également synonyme d'une culture d'entreprise diversifiée, dynamique et ouverte. Chez nous, vous serez encouragé(e) et mis(e) au défi de montrer votre plein potentiel. Afin de renforcer notre...
-
Risk, Compliance
vor 3 Wochen
Plan-les-Ouates, Genf, Schweiz Richemont VollzeitRISK, COMPLIANCE & NON-FINANCIAL REPORTING SPECIALIST Plan-les-Ouates, Geneva, SwitzerlandFixed Term 12 months Through our universe, our collaborators from different horizons share a common objective: the ongoing quest for excellence driven by the outstanding abilities and commitment of the women and men who work in our Maison. As a House of Connoisseurs in...
-
Supply Chain Coordinator
vor 4 Wochen
Plan-les-Ouates, Schweiz Aptissen SA VollzeitWe are looking to recruit a Supply Chain Coordinator to support the daily supply chain routine operations of Aptissen SA. This position is for a temporary contract of 6 months, to support the team during the implementation of an ERP. **KEY TASKS & RESPONSIBILITIES** - Review, improve and run internal planning tools for finished products and raw materials. -...
-
Conseillers/ères à La Clientèle Assurance
Vor 7 Tagen
Yverdon-les-Bains, Schweiz Hestia Conseils Vollzeit**Description du poste** Hestia Conseils est l'entreprise leader dans le domaine du courtage en assurances, immobilier et services financiers en Suisse, l'expansion de notre société est en constante croissance grâce à notre sérieux ainsi que la qualité de nos services. Hestia Conseils emploi des collaboratrices et collaborateurs sur toute la Suisse,...
-
Plan-les-Ouates, Schweiz Bouygues E&S InTec Schweiz AG VollzeitResponsable Technique en Installations Electriques (H/F) BYES propose des solutions globales, flexibles et intelligentes durant tout le cycle de vie des bâtiments, des quartiers et des infrastructures. Chez nous, tu peux faire bouger les choses. Au sein du département Conception et Chiffrage, vous étudiez la faisabilité technique des projets, trouver...
-
Responsable Administrative RH
vor 3 Wochen
Plan-les-Ouates, Schweiz PROEMPLOI Sàrl Vollzeit_Proemploi_ est une société basée sur le Canton de Genève et le Canton de Vaud, nous faisons du recrutement, de la gestion et de la délégation de personnel. Notre domaine de prédilection : Tous les métiers du bâtiment, principalement l'électricité, chauffage, sanitaire et structure métallique. Nous sommes à la recherche d'un/une responsable...
-
Responsable Administrative RH
vor 3 Wochen
Plan-les-Ouates, Schweiz PROEMPLOI Sàrl Vollzeit_Proemploi_ est une société basée sur le Canton de Genève et le Canton de Vaud, nous faisons du recrutement, de la gestion et de la délégation de personnel. Notre domaine de prédilection : Tous les métiers du bâtiment, principalement l'électricité, chauffage, sanitaire et structure métallique. Nous sommes à la recherche d'un/une responsable...
-
Wholesale Sales Representative
Vor 4 Tagen
Plan-les-Ouates, Schweiz Montblanc VollzeitCode de référence: 89243**Wholesale Sales Representative**: - Plan-les-Ouates, GE, CH- PermanentFounded in 1906 as a manufacturer of writing instruments, MONTBLANC today creates exclusive products including watches, jewelry, writing instruments and leather goods which reflect our high demands with respect to culture, quality, design, tradition and...
-
Wholesale Sales Representative
Vor 4 Tagen
Plan-les-Ouates, Schweiz Montblanc North America VollzeitPlan-les-Ouates, GE, CH- PermanentFounded in 1906 as a manufacturer of writing instruments, MONTBLANC today creates exclusive products including watches, jewelry, writing instruments and leather goods which reflect our high demands with respect to culture, quality, design, tradition and craftsmanship. With more than 25 subsidiaries and 600 boutiques...
-
Project Manager for Sonic Suisse Genetics
vor 2 Wochen
Plan-les-Ouates, Schweiz Medisupport VollzeitAbout Sonic Suisse Genetics We are one of the leading private Swiss Genetics Institute, with both medical genetics counselling and laboratory activities. Every day, Sonic Suisse’s over 2600 staff members guarantee precise analytical results and in-depth know-how in various fields of medical diagnostics. We are looking for a: Project Manager for...
-
Conseiller en Assurances Et Prévoyance
vor 4 Wochen
Yverdon-les-Bains, Schweiz Groupe Mutuel VollzeitVous avez trouvé un poste qui correspond à vos compétences et vous êtes motivé à relever ce nouveau défi? Postulez et faites-vous connaître de nos spécialistes en recrutement. **VOS TÂCHES**: - Conseil à la clientèle professionnel dans le domaine de l’assurance-maladie ainsi que de l’assurance-vie, patrimoine et entreprise - Fidélisation...
-
Facility & Office Manager
Vor 3 Tagen
Plan-les-Ouates, Schweiz SwissRoc SA VollzeitAu programme ?Garantir une expérience haut de gamme pour les clients et les collaborateurs tout en supervisant une équipe de 5 Office Managers expérimentés.A ce titre, vos principales missions :Facility management :Gérer et négocier les contrats internes (assurances, entretiens, etc.)Etre garant.e de la qualité des espaces de travail et assurer la...
-
Facility & Office Manager
Vor 4 Tagen
Plan-les-Ouates, Schweiz SwissRoc SA VollzeitFaire sortir un bâtiment du sol, robuste, beau, efficace : plus qu’un métier, c’est un formidable challenge qui nous passionne au quotidien.Chez Swissroc nous recherchons des profils passionnés par la construction, l’immobilier, mais surtout par l’envie d’innover et de dépasser les statu quo.Dans le cadre de notre développement, nous...
-
Facility & Office Manager (h/f)
Vor 4 Tagen
Plan-les-Ouates, Schweiz SwissRoc 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...