Senior IT Compliance Officer

1 day ago

Dombivli, Maharashtra, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 20,00,000
Job Title:

IT Compliance Specialist

About the Role:

This role involves working with our team to ensure compliance with relevant regulatory standards.

  • We are looking for a highly skilled and experienced professional to join our team as an IT Compliance Advisor.
Responsibilities:

The successful candidate will be responsible for the following tasks:

  1. Compliance and Validation:
  • Hands-on experience in compliance and validation roles is required.
  • Strong knowledge of GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5 is necessary.
  • System validation aligned with regulatory standards must be ensured.
  • Review of validation artifacts and identification of traceability or documentation gaps is a key responsibility.
System Life Cycle and Methodologies:
  • Well-versed with System Life Cycle is essential.
  • Hands-on experience with Validation approach, Agile methodology, AIML concepts is required.
Testing/Validation Experience:
  • Review and preparation of: Test Plans, Validation Plans, Risk Assessments is necessary.
  • Requirement Traceability Matrix (RTM), Summary Reports must be prepared.
  • Understanding of the defect lifecycle and validation deliverables is required.
Tools and Technologies :
  • Hands-on experience with tools like HP ALM, Jira, TrackWise, Veeva, QMS systems is necessary.
Quality & Domain Expertise:
  • Knowledge of Quality Management Systems (QMS) is essential.
  • Experience in Healthcare, CRO, or Life Sciences environments is required.
Good to Have Skills :
  • Experience with SaaS validation, automation, and vendor audits is beneficial.
  • Participation in internal/regulatory audits is valuable.
  • Strong documentation skills (SOPs, templates, work instructions) are necessary.
  • Familiarity with risk-based validation and data management is desirable.

Educational Qualification: Any Graduate

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