- Location
- Hyderabad, Telangana, India
- Job type
- Full-time
About the role
KeyBiz Dashboards Pvt Ltd
Website:
mydashboards.in
Job details:
Hyderabad
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Key Responsibilities
- Lead and manage the Quality Assurance department across manufacturing, packaging, warehouse, and laboratory operations.
- Develop, implement, and continuously improve the Quality Management System (QMS).
- Ensure compliance with cGMP, WHO-GMP, US FDA, EU GMP, MHRA, TGA, PIC/S, and other applicable regulatory requirements.
- Review and approve Standard Operating Procedures (SOPs), Master Batch Records (MBRs), validation protocols, qualification documents, and quality documentation.
- Oversee investigations related to deviations, OOS, OOT, change controls, CAPA, and risk assessments.
- Lead internal, customer, and regulatory audits and ensure timely closure of audit observations.
- Provide strategic direction for process validation, cleaning validation, equipment qualification, and computerized system validation.
- Review and approve Annual Product Quality Reviews (APQR/PQR).
- Ensure timely batch disposition and product release.
- Drive data integrity initiatives and foster a quality culture throughout the organization.
- Collaborate with Manufacturing, QC, Engineering, Regulatory Affairs, Supply Chain, and R&D to ensure product quality and compliance.
- Mentor and develop QA teams, ensuring high performance and succession planning.
- Monitor quality metrics and implement continuous improvement initiatives.
- Location Hyderabad
- Website Lita@mydashboards.in
- Salary Best in Industry
- EXPERIENCE NEED Minimum 20 Years
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