Key Responsibilities:Documentation Management:Review, approve, and control various quality documents, including Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), Batch Packing Records (BPRs), Specifications, Test Procedures (STPs), and other quality-related documentation.Ensure proper archiving, retrieval, and revision control of all controlled documents.Participate in the preparation and review of site master files (SMF), validation master plans (VMP), and annual product quality reviews (APQR).In-Process Quality Assurance (IPQA):Conduct regular in-process checks and online monitoring of manufacturing operations to ensure adherence to BMRs, SOPs, and cGMP guidelines.Perform line clearances before starting new batches and product changeovers.Verify dispensing of raw materials and ensure proper handling and storage of materials throughout the production process.Monitor environmental conditions (temperature, humidity, etc.) in manufacturing and storage areas.Collect and control in-process, intermediate, semi-finished, and finished product samples.Batch Release Activities:Review executed BMRs, BPRs, analytical records, and other relevant documentation for completeness, accuracy, and compliance with specifications and cGMP.Ensure all deviations, incidents, OOS/OOT results, and change controls related to a batch are properly investigated, documented, and closed before batch release.Prepare and/or review batch release documentation for final product disposition.Quality Management Systems (QMS):Actively participate in the implementation and maintenance of the Quality Management System (QMS).Initiate, investigate, and close deviations, incidents, Out-of-Specification (OOS), and Out-of-Trend (OOT) results, ensuring root cause analysis and effective CAPA (Corrective and Preventive Actions) implementation.Review and approve change control requests, ensuring proper assessment of impact on product quality and regulatory compliance.Handle and investigate market complaints, product recalls, and customer feedback, ensuring timely resolution and corrective actions.Audits and Inspections:Support internal audits to assess compliance with quality standards and identify areas for improvement.Assist in preparing for and hosting external regulatory inspections (e.g., USFDA, EDQM, WHO) and customer audits.Help in developing and implementing corrective actions in response to audit observations.Validation & Qualification:Participate in the review and approval of validation protocols and reports (process validation, cleaning validation, analytical method validation).Support the qualification and calibration of manufacturing equipment, analytical instruments, and utility systems.Training & Compliance:Provide training to manufacturing and other relevant personnel on cGMP principles, SOPs, and quality-related procedures.Foster a strong quality culture within the organization.Stay updated with the latest regulatory requirements and industry best practices in API manufacturing.Supplier & Vendor Management (as applicable):Assist in the qualification and re-qualification of raw material suppliers and contract manufacturers.Review supplier quality documentation and provide input on supplier performance.
