Job
Description
Role Summary: We are seeking a highly competent and detail-oriented Manufacturing QA Personnel with substantial experience in Sterile Injectable manufacturing , specifically focusing on Small Volume Parenterals (SVP) including Dry Powder, Liquid, and Lyophilized Injections . The selected candidate will ensure shop floor compliance and enforce GMP practices to maintain a state of readiness for inspections and regulatory compliance. Role & responsibilities : Ensure cGMP compliance on the shop floor during all stages of sterile manufacturing (formulation, filtration, filling, lyophilization, sealing, and visual inspection). Conduct and supervise line clearance, in-process checks, and aseptic practices adherence. Monitor and record activities for Dry Powder, Liquid, and Lyophilized Injectable production lines. Perform real-time batch record review and initiate necessary corrections. Ensure cleanroom behavior compliance , including gowning validation, personnel movement monitoring, and hygiene compliance. Coordinate with Production, QC, and Engineering for investigation of deviations, change controls, and CAPAs related to the manufacturing process. Participate in the qualification/validation activities including media fills, equipment qualification, and cleaning validation . Review SOPs, protocols, and BMRs for compliance with regulatory standards and internal policies. Provide training and on-floor guidance to production teams regarding QA best practices and compliance expectations. Ensure readiness for audits and inspections by maintaining appropriate documentation and control practices. Collaborate with cross-functional teams for continuous improvement and risk mitigation in manufacturing QA processes. Required Skills and Competencies: Strong understanding of sterile injectable manufacturing processes and controls, especially for SVP, Dry Powder, and Lyophilized dosage forms. Hands-on knowledge of cleanroom classifications, aseptic techniques, environmental monitoring , and equipment sterilization/cleaning . In-depth knowledge of cGMP, WHO, EU GMP, and PICS regulations . Experience handling deviations, OOS, CAPA, change controls, and batch record reviews . Ability to work in cross-functional teams and provide real-time QA support to operations. Proficiency in documentation practices and QA audits/inspections . Good communication, observation, and leadership skills.
