Assistant Manager - Quality Assurance

To take responsibility for performing multiple QA activities, including batch release, handling and review of validation documents, and review of QMS activities, as well as carrying out GMP related responsibilities and troubleshooting. The candidate shall also be responsible for driving quality system development, providing support and coordination with cross functional teams to achieve key business initiatives, and ensuring compliance with all applicable regulatory and quality standards.

Key duties of the job include:

·      To review Master Batch Records and Executed Batch Records for completeness, accuracy, and compliance with approved specifications and cGMP requirements, and to ensure timely batch disposition and release.

·      Assessment of deviations, change controls, OOS/OOT, incidents, and CAPA impact on batch quality before disposition.

·      Review of AMV, AMT, analytical reports and Certificate of Analysis/Certificate of Compliance  for compliance with specifications.

·      Ensuring compliance with regulatory filing commitments and market specific requirements before release.

·      Review and evaluate Process Validation protocols and reports, including assessment of CPPs, CQAs, sampling plans, acceptance criteria, statistical data, and compliance with registered dossier parameters and quality requirements.

·      Ensure proper documentation, gap assessment, risk evaluation, and timely closure of observations related to validation activities prior to approval.

·      Review Equipment Qualification (IQ, OQ, PQ) documents to verify compliance, operational performance, and suitability for routine and worst case operating conditions.

·      Review of Product Quality review provided by contract manufacturer for Medsurge Registered products.

·      Planning and coordination of training requirements as a part of corrective action and compliance.

·      Independently prepare, review, revise, and update Standard Operating Procedures (SOPs) in compliance with applicable internal quality system requirements, ensuring clarity, accuracy, and controlled documentation.

·      Initiate periodic review of SOPs and track revisions as per document control procedures.

·      Coordinate with cross functional departments for inputs, approvals, and effective implementation of SOPs.

·      Review SOPs of other departments to ensure cross functional alignment, regulatory compliance, and consistency with established Quality Management System requirements.

·      Ensure audit readiness by maintaining accurate, traceable, and controlled documentation at all times.

·      Review and manage QMS activities including deviations, change controls, CAPA, risk assessment ensuring timely closure and compliance with GMP and internal quality requirements.

·      Conduct periodic trending and analysis of QMS documents, including deviations, CAPAs, change controls, complaints to identify recurring trends, compliance gaps, and improvement opportunities.

·      Analyse data to identify areas for improvement in the quality system.

·      Performing the duties on time as assigned by the reporting Manager.