Titolo di lavoro: Quality Assurance Manager

Descrizione del lavoro:
Wyser e' la societa' internazionale di Gi Group che si occupa di ricerca e selezione di middle e senior management specializzato.Facciamo parte di Gi Group, una delle principali realta' a livello internazionale nei servizi dedicati allo sviluppo del mercato del lavoro. For Multinational Pharmaceutical Company we seek a:COMPLIANCE AND VALIDATION ENGINEERING MANAGERHe is responsible for the following three areas: Compliance to industry technical standard and guideline; Compliance standards related to equipments/ systems/ plants/ facilities new design or change (validation); Compliance to GxP and non GxP standard related to maintenance of equipment of equipment/system/plants/facilities (maintenance plan compliance and consistency)IN PARTICULAR: Technical Compliance: the Compliance and Validation Engineering Function supports engineering by assuring compliance to applicable statutory standard on existing equipments/ systems/ plants/ facilities base and ndash; through self inspection, gap analysis, involvement in technical issues resolution. Design: the Compliance and Validation Engineering Function prevents compliance issues by collaborating with engineering design teams reviewing design data; identifying and resolving engineering design issues; identifying short term and long range issues; researching and identifying applicable regulatory and industry compliance standards and codes; developing compliance policies. Review Equipment design in order to guarantee Sterility (sterility assurance engineering). Validation: support operational engineering team by co designing, co authoring and executing design qualification report, validation protocols on equipments/ plants/ systems/ summarize studies and author validation reports in compliance investigate, and close out reports and non conformances associated with validation studies. Investigate and trouble shoot technical issues. Monitoring and Maintenance: the Compliance and Validation Engineering Function is responsible to implement monitoring and/or maintenance equipments/ systems/ plants/ facilities according to applicable statutory regulation and cGMP requirements, including review monitoring plan for equipment bio validation in collaboration with Instrument and amp; Calibration team.Main Skills: Bachelor degree in engineering (Chem or Mech preferred) Minimum of 10 years of experience in Pharmaceutical Engineering with roles in validation or GxP compliance Use of most common software tools (Microsoft suite, SAP) Good of main GMP regulation (Eudralex, cGMP, ISPE, ISO, some relevant pharmacopeia) Good communication skill; and ldquo;working across boundaries and rdquo; attitude due to frequent collaboration with Change Control and Aseptic Guide within the Quality Assurance department.Can send your CV on technical.milano (at) wyser search.comReference TAM_CVE_08I candidati ambosessi (D.lgs. n. 198/2006), sono invitati a leggere sul sito www.wyser.it l and #39;informativa privacy (D.Lgs.196/2003).Wyser (Aut. Min. del 15/04/2014 Prot. N: 39/4903)

Ore per settimana: 0

Nome del datore di lavoro: Wyser - It

Indirizzo datore di lavoro: Piazza IV Novembre, 5 20124 LOMBARDIA, ,

Il numero di telefono di lavoro: +390267490298

Numero di FAX Datore di lavoro: +390266703949

Età minima: 16

Età massima: 65

Job breve descrizione:
Dirigenti dell’industria manifatturiera, dell’estrazione, dell’edilizia e della distribuzione

Nazione: Italia

Regione: Emilia-Romagna

Durata del contratto: Temporaneo

Tipo di contratto: Tempo pieno

Istruzione richiesto: Formazione tecnica superiore

Esperienza: Richiesta

Fonte di offerta di lavoro: Ministero del Lavoro, Italy

Come applicare: Lettera + CV al C.E. di CONTATTO