Cova & Weaver Associati for a Company leader in the pharmaceutical - TopicsExpress

Cova & Weaver Associati for a Company leader in the pharmaceutical research located near Milan has an immediate vacancy in Clinical Department for one: Quality Assurance Manager (Rif. QA Manager) Responsibilities: ·Assist in developing Quality Management System (QMS) documentation (e.g. SOPs, Templates) until approval and authorization. ·Write, update and review, as needed, (departmental) QMS documentation. ·Ensure/provide training prior to implementation of QMS Documents. ·Liaise with (Sub-)Departmental Heads regarding status of QMS Documents. ·Initiate, assist in and follow-up on Planned QMS Document Deviations. ·Organize and keep updated the electronic “QMS Documentation” Libraries. ·Ensure documentation of distribution, return and destruction of QMS Documents. ·Prepare Audit Plan. ·Execute Audit. ·Write Audit Report. ·Make suggestions for improvements and/or CAPA implementation. ·Follow-up on implementation of CAPAs. ·Prepare KPIs for presentation at Management Review Meetings. ·Assist in Regulatory Authorities’ Inspections or Clients’ Audits, and/or related follow-up activities. Profile Qualifications: ·Graduation/Degree in Medical or Life Sciences ·4-5 years experience in Quality Assurance Management ·2-3 years experience in clinical auditing, in compliance with Decree 15 November 2011 Art. 5, including at least 20 days of autonomous auditing in the last year ·Proven GCP, GLP, GMP and regulatory expertise ·Experience in auditing to computerized system, e.g. eCRF ·Knowledge of Clinical Research processes and study management ·Good computer skills and experience in the use of standard office programs (Word, Excel, Power Point, etc.) ·Excellent English skills, written & spoken ·Quality Engineering If your background and personal experience fit the profile, please send your complete application, including a brief description of your experience and your CV and specifying in the subject (Rif. QA Manager), to the following address: [email protected]

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