What we offerVacanciesCompliance Manager

Compliance Manager (GAMP 5)

Europe Ukraine Quality Management
Apply Now

Required skills

GAMP 5 / strong
QMS / good
English / good

We are looking for an experienced Compliance Manager to help us build QMS by GAMP 5 and GMP standards regulations. You will manage, design, and implement compliance policies and procedures, internal audits, and risk assessments in alignment with these standards.

Requirements

  • Regulatory Knowledge:
    • In-depth understanding of GAMP 5 or IEC 62304 guidelines and regulations
  • Quality Management Systems (QMS):
    • Experience in establishing and maintaining QMS compliant with GAMP 5, GMP, IEC 62304, 21 CFR 820
  • Risk Management:
    • Proficiency in conducting risk assessments and implementing risk management processes
  • Computer System Validation (CSV):
    • Familiarity with the principles and practices of computer system validation related to GAMP 5
  • Compliance with International Standards:
    • Knowledge of international regulatory requirements relevant to GAMP 5, GMP, IEC 62304, 21 CFR 820
  • Auditing:
    • Strong background in conducting internal and external audits under GAMP 5, GMP, IEC 62304, and 21 CFR 820 standards
  • Communication Skills:
    • Ability to communicate complex regulatory requirements clearly and effectively
  • Upper-Intermediate level of English and higher
  • At least 2 years of experience in a similar position

Responsibilities

  • Interpreting and Implementing Regulations:
    • Stay updated with GAMP 5 and GMP regulations to ensure compliance
    • Translate complex GAMP 5 and GMP requirements into actionable policies and procedures
  • Policy Development:
    • Develop and maintain compliance policies, procedures, and guidelines specific to GAMP 5 and GMP
  • Monitoring and Auditing:
    • Monitor ongoing compliance with GAMP 5 and GMP
    • Conduct internal audits to identify compliance gaps and areas for improvement
  • Training and Education:
    • Train employees to understand and adhere to GAMP 5 and GMP compliance requirements
    • Educate staff on the implications and consequences of non-compliance
  • Risk Assessment and Management:
    • Identify potential compliance risks related to GAMP 5 and GMP
    • Develop and implement strategies to mitigate identified risks
  • Staying Current with Regulatory Changes:
    • Keep abreast of changes in GAMP 5, GMP, and related regulations or best practices

WHY US

  • Diversity of Domains & Businesses
  • Variety of technology
  • Health & Legal support
  • Active professional community
  • Continuous education and growing
  • Flexible schedule
  • Remote work
  • Outstanding offices (if you choose it)
  • Sports and community activities

REF2884N

Share this vacancy

apply now

apply now

    OR

    Drop your CV here, or

    Supports: DOC, DOCX, PDF, max size 5 Mb


    Submit application

    Take a quiz

    Take a quiz

      Was it comfortable to apply the CV?


      How did you find us?




      Did you hear about us before visiting the site?