Berufsbezeichnung: Chemiker/in Arbeitsort: Basel

Arbeitsbeschreibung:
Einsatzdauer: 02.05.2016 bis 30.11.2016 Ziel der Funktion: Manage projects and processes to support departmental projects and ob-jectives according to agreed timelines and standards and assure com-pliance with GMP is maintained in TRD. Major Activities ¿ Manage portfolio of projects (third parties, analytical instruments and manufac-turing equipment as per area of responsibility) support a discipline and/or provide a service on his/her own or with a team of associates. May provide functional expertise in area of responsibility. ¿ Review and approve deliverables (e.g. procedures, records, third party work, contractors, clinical trial material, components, gap assessments) and related tools (e.g. IT, document systems, training tools, facility validation) to ensure GMP compliance. ¿ Represent TRD QA in initiatives.. ¿ Lead project related activities (e.g. development of new tools, processes, Quality Initia-tives, QM/QDs implementation, Quality Plans, SQRA, training activities, qualification and facility upgrade activities, IT validation projects). ¿ Write, review and approve documents (e.g. procedures, records, SOPs) and related tools (e.g. IT, document systems, training tools, facility validation) to ensure GMP compliance ¿ Perform inspections and audits as required ¿ Contribute to the evaluation of new QA tools. ¿ Provide support to TRD line functions in GMP compliance related issues in area of exper-tise (e.g. medical device standards) . ¿ Support a culture of high performance and trust. Assure that the required level of knowledge and skills is available and identify competency gaps. Establish and implement training and development plans. ¿ Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority guidances, SOPs, HSE, etc). Promote and en-force compliance to guidelines. If managing associates, ensure same for them. ¿ Support project management functions as a sub-team member or in preparation for a PAI. ¿ Write/contribute to internal compliance policy and/or comment to regulations. ¿ Guide team members in line with Novartis values and behavior including objectives set-ting, performance evaluations, development planning and participate in recruiting pro-cess. Additional specific tasks ¿ Approves GMP relevant documents and decision making according to current SOP (¿Glo-bal TRD QA and TRD ¿ Quality Responsibilities; Approval and Release Authorities¿) for the authority of Quality Project Manager and special authority for DSM, and finally with au-thorities delegated to the Quality Team Leader for DSM. ¿ Manages Deviations, Investigations, CAPAs and contributes to or writes trending reports for Deviations / Technical Complaints / Change requests for products and processes of TRD GMP line units and recommends necessary actions to supervisor (Quality matrix). ¿ Contributes to or writes First Time Right performance reports ¿ Supports internal audits of Novartis and audits of third party packaging and la-beling as required ¿ Fulfills SME role as defined in the QA DSM SME matrix. Education ¿ Minimum: Basic degree in science or relevant discipline (BSc or equivalent) ¿ Desirable: Advanced degree in science of relevant discipline (MSc or equivalent) Languages: ¿ Fluent English required (oral & written). ¿ Good skills in site (local) language (German) desired (oral). Experience/Professional requirement: ¿ Good knowledge of cGMP, working knowledge in technical development, production or QA. ¿ Sound scientific, technical and regulatory knowledge. ¿ Broad working experience (min. 5 years) in TRD, production or QA (e.g. several years of experience as head of laboratory). ¿ Good organizational skills. ¿ Good and proven ability to analyze and evaluate GMP compliance

Stunden pro Woche: 40

Angestelltenname: ELAN Personal AG

Arbeitgeber-Adresse: Leimgrubenweg 16, CH-4053 Basel, Schweiz

Form von Kontakt: Renato Imboden

Arbeitgeber Telefonnummer: +41 61 3363333

Arbeitgeber Faxnummer: +41 61 3363339

Stellenkurzbeschreibung: Chemiker

Land: Schweiz

Region: SCHWEIZ/SUISSE/SVIZZERA

Vertragslaufzeit: Befristet

Vertragstyp: Vollzeit

Erforderliche Ausbildung: Keine Angabe

Quelle des Stellenangebots: BA, Öffentliche Arbeitsverwaltungen, Deutschland

Wie Sie sich bewerben: Weitere Angaben (siehe Beschreibung)

Gehalt Währung: EUR

Gehaltsperiode: monatlich

Gehalt Besteuerung: brutto