
Compliance Specialist
19 hours ago
Job Title: Compliance Officer
Project Role: IT Compliance Specialist
Experience: 4-7 years of experience in compliance and validation roles, with strong knowledge of GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5.
Work Mode: Hybrid work environment with flexibility to work from home or office.
Key Responsibilities:
- Hands-on experience in compliance and validation roles, ensuring alignment with regulatory standards.
- Review and preparation of test plans, validation plans, risk assessments, requirement traceability matrix (RTM), summary reports, and understanding of the defect lifecycle and validation deliverables.
- Experience with system life cycle methodologies, including Agile approach, AIML concepts, and hands-on experience with tools like HP ALM, Jira, TrackWise, Veeva, and QMS systems.
- Knowledge of quality management systems (QMS) and experience in healthcare, CRO, or life sciences environments.
Requirements:
- Strong documentation skills (SOPs, templates, work instructions)
- Participation in internal/regulatory audits
- Good communication and collaboration skills
What We Offer:
- A competitive compensation package
- A dynamic and supportive work environment
- Opportunities for professional growth and development
We are an equal opportunities employer and welcome applications from diverse candidates. Please submit your application, including your resume and cover letter, to [insert contact information].
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