Puainthran Naidu

• Developed strong relationships with stakeholders to facilitate smooth batch release transaction in Production Drug Product.
• Enhanced employee performance by providing regular feedback, coaching, and training pertaining to Shopfloor activities and inprocess checks in Production Drug Product.
• Liaised with team members, stakeholders and QP to coordinate batch disposition activity pertaining to Production Drug Product.
• Supervised day-to-day operations to meet performance and quality expectations in shop floor activity at Production Drug Product.
• Overall in-charge of Batch Record Management in Biocon pertaining Production Drug Product.
• Support QMS team in Deviation review, Deviation closure, SOP revision and CAPA closure whenever required.

-Coordinating meeting for related cross functional teams related to Peer Review.
-Performing In-Process QA activities primarily routine in-process checks, line clearance, etc. Online reviewing of batch records and monitoring of manufacturing activities.
-Ensure adherence of compliance at Production Drug Product (Cleanrooms and Utilities) and to notify any non-conformities.
-Working and supporting the team for internal and external audits (regulators/ customers/ partners).
-Any other assignment given by reporting manager.
-Co-ordinate with IPQA team in day to day activity.
-Performs S.O.P and Batch record approval.
-Involving in Change Management Approval.
-Planning and execute the batch release activity by coordinating with cross-functional team and perform the batch release activity.
-Handles the S.A.P activity pertaining to QA roles

Performing In-Process QA activities such as routine in-process checks, line clearance, online review of Drug product batch records, monitoring drug product manufacturing activities, involving in investigation related to QA and Production activities,implementation of CAPA as per investigation outcome,performing cGMP audits including preparation of reports and follow up CAPA,working ans supporting the team for internal and external Audits, managing In-Process QA team and training of cross fuctional teams on Quality Assurance SOP.

Performing In-Process QA activities such as routine in-process checks, line clearance, online review of Drug product batch records, monitoring drug product manufacturing activities, involving in investigation related to QA and Production activities,implementation of CAPA as per investigation outcome,performing cGMP audits including preparation of reports and follow up CAPA,working ans supporting the team for internal, Batch Record Closure as well as external Audits and training of cross fuctional teams on Quality Assurance SOP

Performing In-Process QA activities such as routine in-process checks, line clearance, online review of Drug product batch records, monitoring drug product manufacturing activities, involving in investigation related to QA and Production activities,implementation of CAPA as per investigation outcome,performing cGMP audits including preparation of reports and follow up CAPA,working ans supporting the team for internal and external Audits and training of cross fuctional teams on Quality Assurance SOP.

Responsible and accountable for all aspect of quality control functions.
• To ensure that a Data Collection System exists in the shop floor to accurately and comprehensively captured the product quality performance in respect to rejects and customer complaints.
• To recommend any changes required for improvement in respect to the quality management system to the Quality Assurance Committee.
• To develop and undertake the in-house training of production and quality assurance staff in respect to induction, skill-enchancement and supervisory skill in accordance to the company’s operation manual.
• Responsible in contribution towards accreditation and maintain conformance of ISO 9001:2008 and TS 16949.
• To assist and trouble shoot on quality related matters.
• To perform specific outgoing quality inspection and submit inspection data sheets when required by customers.
• To monitor and given an approval for all incoming and outgoing quality inspection.
• To ensure that monthly Quality Assurance report is made by 10th every month.
• Act as Internal Auditor for the company.
Perform technical assignment and data entry.