Deputy Manager-QA

• To prepare Annual Product Review (APR) as per schedule planner.
• Issuance & handling of logbooks for all quality management system.
• Management of all Master documents Manual and Electronic format of all the departments.
• To maintain Issuance, Retrieval, and destruction of documents.
• Management of Executed Batch Records, Logbooks and other GMP records.
• Support in Internal and external audits of the facility including compliance.
• Handling of QMS activities and provide like, deviation, change control etc.
• Management of Approved Master Calibration Planner and Calibration Master List
• Visual inspection of control samples as per SOP.
• Management of Temperature monitoring data loggers in control sample and document room.
• Destruction of Control Sample, Batch Record s, Logbook s and other GMP Records.
• To ensure effectiveness of implementation of continuously changing regulatory requirement.
• Submission of documents to Customer/corporate regulatory affairs.
• Ensure effective implementation of systems and procedures as per cGMP, GLP, ISO 13485 and other regulatory/customer requirements.
• Management of Control Sample and Document room.
• Record Data logger information in sequential log during dispatch of FG goods.
• To ensure the EHS (Environment, Health and safety) related activities to be completed on time and to support EHS activities as per requirement. To report near miss and incidences as observed as per EHS requirement.
• Monitoring and provide guidance to subordinates.
• Support to Site DICO (Data Integrity Compliance Officer) for monitoring and implementation of actions related to Data Integrity awareness at site.
• Preparation of SOPs related to Quality Assurance.
• Support in vendor management activity

M. Sc. /Bachelor of Pharmacy, Technical background is preferred