CFR 21 Part 11 Compliance Specialist ERP Implementation
CFR 21 Part 11 Compliance Specialist ERP Implementation
Posted on :
11-04-2025
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1 Vacancy
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Job Description
Job Summary:
We are seeking a knowledgeable and detailoriented Compliance Specialist to ensure that our ERP implementation adheres toCFR 21 Part 11regulations. The ideal candidate will have expertise in regulatory compliance for electronic records and electronic signatures with experience in ERP systems and life sciences industries. This role will collaborate with crossfunctional teams to design implement and validate ERP solutions that comply with FDA regulations.
Key Responsibilities:
Compliance Management:
- Ensure ERP systems and processes meet allCFR 21 Part 11requirements for electronic records and signatures.
- Develop and maintain documentation for compliance activities including validation plans protocols and reports.
Validation and Testing:
- Lead system validation efforts (e.g. IQ OQ PQ) to verify compliance.
- Coordinate testing activities to confirm data integrity security and accuracy within the ERP system.
ERP Implementation Support:
- Collaborate with ERP project teams to align implementation with regulatory requirements.
- Provide guidance on system configurations to ensure compliant workflows and data management.
Training and Audits:
- Train endusers and stakeholders on Part 11 compliance requirements.
- Prepare for and assist in internal and external audits addressing compliancerelated queries.
Risk Assessment:
- Conduct risk assessments related to electronic records and data integrity.
- Recommend mitigation strategies to address compliance risks.
Change Management:
- Evaluate the impact of system changes or updates on compliance.
- Ensure compliance is maintained throughout system upgrades or migrations.
Qualifications:
Education:
- Bachelors degree in Computer Science Information Systems Life Sciences or a related field.
Experience:
- 5 years of experience in regulatory compliance specifically withCFR 21 Part 11.
- Handson experience with ERP systems (e.g. SAP Oracle Microsoft Dynamics).
- Experience in the pharmaceutical biotech or medical device industry is highly preferred.
Skills:
- Strong understanding of FDA regulations and GxP guidelines.
- Proficiency in system validation methodologies (e.g. Vmodel).
- Knowledge of electronic records management audit trails and data integrity principles.
- Excellent communication and documentation skills.
Preferred Skills:
- Experience with electronic Quality Management Systems (eQMS).
- Familiarity with cybersecurity principles as they relate to compliance.
- Certification in Quality or Compliance (e.g. RAC Six Sigma).
Key Competencies:
- Attention to detail and ability to manage multiple priorities.
- Strong problemsolving skills and ability to work collaboratively across teams.
- Analytical thinking with a focus on regulatory adherence and operational efficiency.
Work Environment:
- Fulltime position; may require travel for audits or ERP project activities
Required Experience:
Unclear Seniority
Employment Type
Full-Time
Key Skills
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