
Compliance Specialist Position
2 weeks ago
We are seeking a skilled Compliance Specialist to join our team. As a key member of our organization, you will be responsible for ensuring that our systems and processes align with regulatory requirements.
This includes hands-on experience in compliance and validation roles, as well as a strong understanding of GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5.
Key Responsibilities:
- Hands-on experience in compliance and validation roles
- Strong knowledge of GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5
- System validation aligned with regulatory standards
- Review of validation artifacts and identification of traceability or documentation gaps
System Life Cycle and Methodologies:
- Well-versed with System Life Cycle
- Hands-on experience with Validation approach, Agile methodology, AIML concepts
Testing/Validation Experience:
- Review and preparation of: Test Plans, Validation Plans, Risk Assessments
- Requirement Traceability Matrix (RTM), Summary Reports
- Understanding of the defect lifecycle and validation deliverables
Tools and Technologies:
- Hands-on experience with tools like HP ALM, Jira, TrackWise, Veeva, QMS systems
Quality & Domain Expertise:
- Knowledge of Quality Management Systems (QMS)
- Experience in Healthcare, CRO, or Life Sciences environments
Good to Have Skills:
- Experience with SaaS validation, automation, and vendor audits
- Participation in internal/regulatory audits
- Strong documentation skills (SOPs, templates, work instructions)
- Familiarity with risk-based validation and data management
Educational Qualification: Any Graduate
Bonus Points: Prior experience in similar roles; certifications in relevant areas; Proficiency in more than one programming language; Strong analytical skills with ability to interpret complex data.
About This Role: The successful candidate will demonstrate excellent problem-solving skills, effective communication, and the ability to collaborate with cross-functional teams.
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