AM - Quality Assurance Jubilant Pharmova Limited

5.0 - 9.0 years

0 Lacs

karnataka

On-site

As a Quality Assurance Specialist, your primary responsibility will be to handle Change Management, Deviations, Out of Trend, Out of Specification, and CAPA closure before the product release. This includes coordinating QMS activities in the Track Wise system and managing documents through the SAP system. It is essential to track and complete all QMS activities within the specified due date. You will be tasked with coordinating complaint investigations, managing Return Goods, and handling Recalls. Additionally, reviewing contract manufacturing and testing documents such as executed BPR and Analytical reports will be part of your duties. Your role will involve performing unplanned audits on the shop floor, monitoring the Manufacturing Process to identify root causes for product failures and cleaning incidents, and reviewing and closing Change control and related action items. Archiving of change control and other related documents will also fall under your purview. Preparation of Quality Assurance SOPs, reviewing plant SOPs, handling change control and deviations related to warehouse & SCM, and preparing and reviewing Risk Assessment reports for New Products & process change products are critical tasks that you will be responsible for. You will also be required to prepare risk assessments and declarations as per customer requirements and current guidelines. Reviewing Vendor Qualification documents, communicating with Vendors/Supply Chain Management, preparing Vendor audit schedules, implementing schedules as defined, maintaining SOP formats and Annexures, updating Approved Vendor lists periodically, and preparing and reviewing Annual Product Quality Reports and Product Quality metrics are key components of your role. Furthermore, you will review process validation protocols and reports, prepare and review cleaning validation protocols and reports, and handle any work assigned by your reporting Manager. In the absence of the position holder, operational responsibilities will be delegated to Direct reports or a designee.,

Posted 1 week ago

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