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Regulatory Compliance Specialist
2 months ago
As a Regulatory Compliance Specialist at SUNWARD PHARMACEUTICAL PRIVATE LIMITED, you will be responsible for ensuring the entire operational aspects of the company adhere to established SOP, GMP, GDP, and GLP practices and regulatory requirements. This includes handling issues from cross-functional departments, ensuring procedures and practices are adhered to in accordance with cGMP requirements, and conducting risk assessments. Additionally, you will be involved in vendor audits, evaluation, and qualification, as well as providing expertise in CAPA and deviation management. If you have strong management skills, experience with vendor audits, and a background in regulatory requirements, this could be the ideal role for you.
Key Responsibilities
- Ensure operational aspects adhere to established SOP, GMP, GDP, and GLP practices and regulatory requirements.
- Handle issues from cross-functional departments, including QC, Production, Warehouse, and Engineering.
- Conduct risk assessments and collect samples during validation processes.
- Provide expertise in vendor audits, evaluation, and qualification.
- Manage CAPA and deviation processes.
Requirements
- Strong management skills.
- Experience with vendor audits.
- Background in regulatory requirements.
- Ability to work in a fast-paced environment.
