Assistant Manager-QMS

Job Description

Quality Management System: Oversight/Handling of Handling of Change Control, Incident / Deviation and CAPA. Following and tracking of Change Control, Incident /Deviation and CAPA. Involved in the investigation activity whenever required. Ensure that products are manufactured in compliance to Regulatory requirements and as per Good Manufacturing Practices. Ensure that production and manufacturing activities are undertaken in compliance to SOPs, systems, procedure and GMP/GLP requirements. Maintain GMP compliance in various departments to manage the production in line with the current GMP requirement. Handling of Change Control, Deviation, risk assessment and CAPA as per company procedure Verification & Follow-up of CAPA implementation as per provided target completion date. Involved in the handling of Market Complaints. Review of QMS documents. Vendor Qualification Activity: Oversight of Vendor Qualification related documentation. Planning and execution of the vendor Qualification activity with co-ordination with user department. Preparation and review of document related to Vendor Qualification. Execution of schedule / planned Vendor/Supplier Qualification as per the Protocol. Qualification/ Validation - Data compilation and Report preparation. Review and compilation of data generated in validation and qualification of vendors. Coordination with external agency for Qualification, validation, calibration and outside services related to Vendor Qualification. Qualification of External agency for Qualification, Validation and Calibration agency as per the SOP. Planning of the vendor audit as per requirement. Self-Inspection: Oversight of Self-Inspection program 4. Management and overall tracking of audit observation- Audit & Compliance (Internal and External audit). Oversight of IPQC & Microbiology Section: - Ensure in-process product and process related quality assurance activities (IPQA) are undertaken by IPQC team. Validation and Qualification Activity: Review of Validation and qualification related activities as and when required. Planning of the validation activity with co-ordination with user department.