· Develop and Maintain Qualification Documents:
o Prepare and update qualification protocols (Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)) for equipment and systems.
o Coordinate and execute qualification activities for new equipment and facilities.
o Review and approve qualification documents ensuring they meet industry standards and regulatory requirements.
· Quality Management System (QMS):
o Implement and maintain a robust Quality Management System (QMS) to ensure compliance with regulatory and company standards.
o Conduct internal audits and inspections to ensure adherence to QMS and identify areas for improvement.
o Participate in external audits and regulatory inspections, ensuring timely responses to audit findings.
· Documentation and Record Control:
o Ensure all quality-related documentation, including Standard Operating Procedures (SOPs), Work Instructions, and batch records, are up to date and properly controlled.
o Review and approve quality-related documents for accuracy, completeness, and compliance with company standards.
· Deviation and CAPA Management:
o Investigate quality deviations and non-conformities, ensuring appropriate Corrective and Preventive Actions (CAPA) are implemented.
o Conduct root cause analysis and drive continuous improvement initiatives to mitigate future occurrences.
· Supplier and Vendor Qualification:
o Assist in the qualification and approval of suppliers and vendors, ensuring they meet quality requirements.
o Monitor supplier performance through regular audits and assessments.
· Product Release and Control:
o Review batch records and final product inspections before release to ensure they meet defined quality criteria.
o Ensure proper labeling, packaging, and documentation for final product release.
- Quality Control:
- Perform routine quality control tests and inspections on raw materials, in-process products, and finished goods.
- Conduct inward material/raw material inspection from time to time and inform the store department to process further.
- Identify and document quality issues and non-conformances and implement corrective actions.
- Maintain detailed records of quality control tests, inspections, and corrective actions.
Pay: ₹25,000.00 - ₹30,000.00 per month
Work Location: In person
