Harman Finochem Ltd
We are looking for Quality Compliance Executive
- To establish, document, and implement a quality management system, and to ensure effective implementation, monitoring, and control of quality management system at our API manufacturing, testing, and warehouse activities with respect to laid down procedures, systems and identify areas for improvement.
- To review the validation master plan of the plant and comply with the validation requirements of various regulatory authorities and customers.
- To review SOPs, batch manufacturing and packing records, specifications, and test methods of the products.
- To monitor, control, and review deviations, change controls, out of specifications may occur at all stages of storage,
dispensing, manufacturing, packing, testing, and distribution.
- To ensure issuance, control, distribution, storage, retention, and destruction of quality documents and corporate guidelines as per quality management system.
- To ensure that all critical equipment and utilities used to manufacture the product are under-qualified statuses, calibrated, and under routine preventive maintenance program.
- To ensure proper investigation of market/customer / regulatory complaints by root cause analysis, corrective actions and ensure effective implementation of CAPA initiatives, close the complaints, send responses to the complainants, and verify the effectiveness of CAPA periodically.
- To evaluate batch records, COAs and release finished products for sale. To ensure that, all the operations are carried out are as per GMP and laid down procedures, that each production batch complies with the provisions of the Drugs and Cosmetics Act and other legal, customer, and regulatory requirements.
- To ensure compliance to the regulatory, customer, legal requirements, face audits, and comply with nonconformities observed during the audits.
- To carry out self-inspections and ensure compliance to the manufacturing, testing, and warehousing facility audit observations.
- To ensure completion of APRs of products and take appropriate actions in case of deviations.
- Recommendation to recall approving authority on product recall, review, and disposition of recalled and returned goods.
- Handling of online and in-process rejections and taking appropriate actions to avoid recurrences and dispositions.
- To coordinate with CQA for up-gradation in the SAP systems as per any changes or new products at Mahad site.
- To monitor the stability of products, control sample storage and compilation of analytical reports, and take appropriate action in case of failures.
- To identify and provide resources with coordination with other departments to carry out quality functions effectively.
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