Compliance and Validation Expert

24 hours ago

Pune, Maharashtra, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 20,00,000

Job Title: Regulatory Compliance Specialist

Project Role: IT Compliance Advisor with a focus on ensuring regulatory compliance in the healthcare, CRO, and Life Science industries.

Experience: 4-7 years of hands-on experience in compliance and validation roles is required.

Work Mode: Hybrid work arrangement is available.

Mandatory Skills:

  • Familiarity with GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5 regulations.
  • Hands-on experience with system validation aligned with regulatory standards.
  • Strong documentation skills for creating validation artifacts and identifying traceability or documentation gaps.
  • Excellent knowledge of Quality Management Systems (QMS) and domain expertise in Healthcare, CRO, or Life Sciences environments.

About the Job:

We are seeking an experienced Regulatory Compliance Specialist to join our team. The successful candidate will have a strong background in IT compliance and a passion for staying up-to-date with the latest regulatory requirements.

Key Responsibilities:

  • Review and prepare validation documents such as Test Plans, Validation Plans, and Risk Assessments.
  • Develop and implement quality management systems to ensure compliance with industry regulations.
  • Collaborate with cross-functional teams to identify and mitigate risks associated with system validation.
  • Participate in internal and external audits to ensure compliance with regulatory requirements.

Requirements:

To be successful in this role, you should have:

  • A bachelor's degree in a relevant field.
  • At least 4-7 years of experience in compliance and validation roles.
  • Excellent communication and interpersonal skills.
  • Ability to work in a hybrid environment.

What We Offer:

We offer a competitive salary, excellent benefits package, and opportunities for career growth and development.

Contact Us:

If you are a motivated and detail-oriented individual with a passion for regulatory compliance, please submit your application.

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