6 days old

Quality Auditor (GMP)

Abbott
Москва, Центральный федеральный округ 125009
Main responsibilities:
  • Manage on site and desktop GxP audits for regional and local Suppliers and Third-party manufacturers (TPM) and affiliates (EPD Affiliate and Veropharm).
  • All activities required to plan, prepare for, conduct, report and close the assigned audits.
  • Ensure that all audit related information is documented into the Audit Tracking system in a timely manner.
  • Work with Quality Questionnaire for Suppliers, affiliates and TPMs regionally
  • Reviewing any Quality Questionnaires returned by the Suppliers/TPMs and resolving any issues.
  • Escalation of any critical findings or negative audit outcomes to Audit and compliance Manager and regional Quality Director, in line with the applicable policy and procedures.
  • Assess the appropriateness and timeliness of proposed CAPAs, and track CAPA follow-up to close for affiliates, regional supplier and TPMs.
  • Discuss with and agree with the affiliates, Suppliers and TPMs a timely implementation of corrective and preventive actions, as needed to prevent recurrence.
  • Read and extract developing regulations and trends from available sources to provide recent perspectives during audits.
  • Ensure a proactive determination of regulatory, compliance and quality issues and integrate them into audits/assessments on a priority basis.
  • To maintain the system for insuring of External Inspections and AQR audits readiness of Veropharm manufacturing sites and commercial affiliates (EPD and Veropharm).
  • Actively participates on cross-functional team projects in a structured business environment in accordance with internal procedures and external regulations.
  • Participate in implementation of self-inspection plans for commercial affiliates and Veropharm manufacturing sites to provide comprehensive readiness of affiliate and manufacturing sites for AQR and external audits.

    Requirements:

    • University (high) education at a relevant scientific discipline or other technical/scientific, or industry experience with sufficient exposure to pharmaceutical or related industries.
    • ISO Certified Quality Auditor (CQA) Certified Quality Engineer (CQE), or other international certification desirable (as a big plus).
    • At least 5 years in the Pharmaceutical Industry and/or related industries; and at least 3 years of GXP Auditing experience.
    • Knowledge and understanding of the relevant GxP, PICs, ICH, WHO and other relevant technical guidelines, Russian legislation.
    • Ability to communicate, understand and mentor individuals in highly specialized technical fields.
    • Project Management and troubleshooting skills.
    • Flexibility in communication with representatives of different nations, cultures
    • Advanced written and verbal skills in Business English.
    • Readiness for business trips for around 50 % of working time.
    • No restrictions on entry to foreign countries (EU, China, India, Turkey, UK, Ireland, Israel, etc.)

      Benefits:

      • Work with a highly professional team.
      • Opportunity of professional and career growth.
      • Medical and life insurance.

        Division: EPD Established Pharma
        Travel: Yes, 50 % of the Time
        Medical Surveillance: Yes
        Significant Work Activities: Awkward/forceful/repetitive (arms above shoulder, bent wrists)

        Categories

Posted: 2020-03-23 Expires: 2020-04-22

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Quality Auditor (GMP)

Abbott
Москва, Центральный федеральный округ 125009

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