Berufsbezeichnung: QA Compliance Manager (f/m) Arbeitsort: Basel

Arbeitsbeschreibung:
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 Initiatives, 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 expertise (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 enforce 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 setting, performance evaluations, development planning and participate in recruiting process. Additional specific tasks ¿Approves GMP relevant documents and decision making according to current SOP (¿Global 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 authorities 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 ¿Basic degree in science or relevant discipline (BSc or equivalent) ¿Desirable: Advanced degree in science of relevant discipline (MSc or equivalent) ¿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. ¿Fluent English required (oral & written). ¿Good skills in site (local) language (German) desired (oral). - Geforderte Anlagen: Lebenslauf, Zeugnisse

Stunden pro Woche: 40

Angestelltenname: Peppercorn Human Experts AG

Arbeitgeber-Adresse: Erlenstrasse 1, CH-4058 Basel, Schweiz

Form von Kontakt: Farina Streil

Arbeitgeber Telefonnummer: +41 61 2264455

Stellenkurzbeschreibung: Apotheker

Land: Schweiz

Region: SCHWEIZ/SUISSE/SVIZZERA

Vertragslaufzeit: Unbefristet

Vertragstyp: Vollzeit

Erforderliche Ausbildung: Keine Angabe

Erfahrung: Gefordert

Quelle des Stellenangebots: BA, Öffentliche Arbeitsverwaltungen, Deutschland

Wie Sie sich bewerben: Weitere Angaben (siehe Beschreibung)

Gehalt Währung: EUR

Gehaltsperiode: monatlich

Gehalt Besteuerung: brutto