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Вакансии Аудит

About our client: Our client is a global pahramceutical company.
Job description:
- Conduct audits of the company operational sites and Global Third Parties for the purpose of identifying any non-compliance to the company Quality Manual, National/International GxP requirements, and Local Standard Operating Procedures
- Conduct surveillance, due diligence, for-cause audits, Mock PAIs, as well as Quality System verification audits
- Manage inspections by Health Authorities, as applicable
- Plan, schedule, coordinate and conduct audits
- Evaluate and communicate compliance of audited site/operation to the Auditee as well as the Management
- Review and approve, in collaboration with the responsible Quality units, proposed corrective/preventative action plans
- Verify implementation and effectiveness of agreed corrective/preventative actions
- Analyse, report and trend audit observations
- Complete Lessons Learned and share Best Practices resulting from audits/inspections
- Provide training to Quality organization in audit fundamentals
Who we are looking for:
- Bachelor of Science Degree in Chemistry, Pharmacy, Biology, or Related Science; advanced degree preferred
- Excellent technical writing and oral communication skills required
- Minimum of 8 years industry experience, including a minimum of 5 years full-time auditing experience (defined as 5 audits/year, or equivalent)
- Pharmaceutical industry related to Quality Assurance, Quality Control, Drug Regulatory Affairs, Manufacturing Operations, or equivalent
- Working knowledge of regulatory agency requirements; US FDA, EMEA, MHRA, WHO, ANVISA, US DEA, ICH, INVIMA, ISO, MDD, as well as others required
- Experience in international & multidisciplinary environments
- Willingness to travel worldwide, sometimes at short notice: travel time 60-70%
- Good interpersonal and leadership skills
- Excellent knowledge of computer systems; i.e. Microsoft Word, Excel, PowerPoint, & Visio
- Good English skills required; excellent fluency in a local language, communication & negotiation skills (oral and written)
What we offer: Michael Page Contact Please apply online quoting reference number KVKO58563 Your application will be sent to Victoria Kononova


Michael Page

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