Regulatory Compliance Specialist
2 weeks ago
Regulatory Compliance Specialist
About the Role:We are seeking a highly skilled Regulatory Compliance Specialist to join our team at Recruit Express Pte Ltd.
About the Role:- Support Validation Projects: Assist with qualification and validation activities, ensuring compliance with regulatory requirements.
- Review and Approve Documents: Review and approve validation documents like protocols, reports, and procedures.
- Manage Discrepancies: Identify and address issues in validation protocols, ensuring corrective actions are documented.
The ideal candidate will have a strong understanding of FDA/EU cGMP requirements, including CFR 21 Part 11, and familiarity with PDA and ISPE GAMP guidelines.
Key Responsibilities:- Qualification and Validation Activities: Assist with qualification and validation of equipment, processes, cleaning, and computer systems.
- Document Review and Approval: Review and approve validation documents, ensuring they meet regulatory requirements.
- Discrepancy Management: Identify and address issues in validation protocols, ensuring corrective actions are documented.
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