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Cfr 21 Part 11 Compliance Specialist - Erp Implementation @ Dotsolved Systems

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 Cfr 21 Part 11 Compliance Specialist - Erp Implementation

Job Description

About UsdotSolved, headquartered in Silicon Valley USA, is a leading global provider of business process automation, modern application engineering, and cloud infrastructure services. dotSolved focuses on enabling digital transformations for small, medium, and large enterprises, in the following industries (but not limited to)High technology, Energy, Manufacturing, Financial Services, Media & Entertainment, Communications, Retail, Healthcare, and Education. dotSolved drives digital transformations for enterprises by defining, automating, and optimizing complex business processes for the digital era and engineering modern, data & analytic driven, applications that deliver intended business value. With hundreds of successful implementations and experience in Big Data, ERP, and Supply Chain, dotSolved can guarantee the creation of measurable business value from project engagements leading to accelerated business growth and profitability for customers.
  • About The Role Job Summary
  • We are seeking a knowledgeable and detail-oriented 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 cross-functional 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 end-users and stakeholders on Part 11 compliance requirements.
  • Prepare for and assist in internal and external audits, addressing compliance-related 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:
  • Bachelor's 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.
  • Hands-on 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., V-model).
  • 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 problem-solving skills and ability to work collaboratively across teams.
  • Analytical thinking with a focus on regulatory adherence and operational efficiency.
  • Work Environment:
  • Full-time position; may require travel for audits or ERP project activities
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    • Job Classification

    Industry: IT Services & Consulting
    Functional Area / Department: Consulting
    Role Category: IT Consulting
    Role: Technical Consultant
    Employement Type: Full time

    Contact Details:

    Company: Dotsolved Systems
    Location(s): Chennai

    + View Contact

    Keyskills:   fda documentation regulatory compliance regulations gxp pq erp biotechnology oq sap oracle data validation erp implementation iq system validation microsoft dynamics business analysis gamp quality assurance computer system validation

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