Regulatory Compliance Manager
1 week ago
About the Role: As a Senior Validation Manager, you will play a crucial part in ensuring the quality and regulatory compliance of our clients' Veeva implementations. With 15-18 years of experience in life science and Veeva implementation, you will lead teams in testing and validation activities, creating and reviewing IQ, OQ, PQ, RTM, and 21 CFR Part 11 validation plans.
- Your primary focus will be on planning and strategizing testing and validation activities, utilizing your strong project management skills to coordinate team members and unblock any hurdles.
- You will have hands-on experience in using test management tools like ALM and JIRA, as well as strong communication skills and good customer handling skills.
Key Responsibilities:
- Lead teams in testing and validation activities for Veeva implementations.
- Create and review IQ, OQ, PQ, RTM, and 21 CFR Part 11 validation plans.
- Utilize test management tools like ALM and JIRA to streamline processes.
- Cultivate strong relationships with clients and stakeholders through effective communication and customer handling skills.
Requirements:
- 15-18 years of experience in life science and Veeva implementation.
- Strong hands-on experience in validation space.
- Hands-on experience in creating and reviewing IQ, OQ, PQ, RTM, and 21 CFR Part 11 validation plans.
- Experience in usage of test management tools like ALM and JIRA.
- Strong project management skills.
- Strong people management skills.
- Strong communication skills and good customer handling skills.
About Us: At Tekfortune Inc., we are dedicated to providing top-notch consulting services to our clients. Our experienced team is committed to delivering high-quality results that meet the highest standards of regulatory compliance. We offer competitive salaries and benefits packages to attract the best talent in the industry.
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