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Job Descrption
Company Description
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.
Job Description
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
Qualifications
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
Complete form below to directly Send your CV / Linkedin Profile to Compliance Manager (GAMP 5) at Sigma Software.
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