Quality Assurance Engineer

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  • Categoria professionale
    Quality Assurance Manager settore farmaceutico
  • Data inizio
  • Settore

Provides quality focused engineering support to develop, support and maintain validation / maintenance strategy ensuring it is compliant with Eng Standards, LQS, LQP and Local SOP
- Ensures commissioning and qualification phases of utilities systems and ensure that systems remain validated throughout the life cycle of the system
- Support cross-functional teams to investigate and address manufacturing non conformances engineering / utilities/ maintenance related
- Support investigation by conducting problem solving and root cause analysis to address engineering / Utilities / maintenance failures identified
-Identify, create, maintain and publish quality trends
-Identify and implement opportunities to improve quality system and manufacturing processes
- Quality rep- inside the Utilities Module

• Provides interpretation of GMP standards, LQS, LQP ,GQS, Engineering standards and Local SOP from the design to the maintenance of a system and guarantee their implementation on HVAC, Utilities systems
• Develops risk assessment approaches to specific cases when necessary
• Ensures and / or performs the QA support for the verification of the qualification and validation activities on facilities and utilities systems lifecycles
• Ensure Q process monitoring (alarms mgmt) and in the Utilities module and maintenance board.
• Collaborate to the alarms classification
• Approves appropriate qualification / validation on facilities and Utilities systems within the set deadlines (e.g. CLIA/SLIA, COD, URS, DQ, IQ/OQ)
• Approves the maintenance program, the Preventive maintenance Plan and work instruction (if applicable)
• Facilitates decision making on the design and quality aspects of the Projects / systems in scope
• Cooperates in the investigation of deviation equipment / maintenance related
• Implement corrective action plans to avoid recurrency of deviations utilities/maintenance related
• Approves change control activities of maintenance / improvement program
• Approves deviations equipment / maintenance related
• Review and approve Utilities /maintenance SOPs
• Plan the activities related to shutdown and return to service in collaboration with Sterility assurance
• Collaborate to guarantee the compliance of the activities of the dept respect to the Q gap analysis.
• Review metrics and participate to the appropriate process team

Disponibilità oraria: Full Time

Osservazioni: REQUIRED QUALIFICATIONS / QUALIFICHE RICHIESTE Titolo di studio: Laurea (Scientific degree – Engineering / Chemistry preferred) Conoscenza lingua: Fluent english Formazione/Esperienza - Experience on manufacturing activities - Knowledge of manufacturing computer systems; - Knowledge of Quality environment; - Knowledge of Production processes; - Certification CSQA

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I candidati ambosessi (L.903/77) sono invitati a leggere l’informativa sulla privacy (art.13, D.Lgs.196/03).

Facsimile di domanda disponibile al seguente link Facsimile domanda candidatura.
Adecco Italia S.p.A (Aut. Min. Prot. N. 1100-SG del 26/11/2004)