Candidate acquainted of Quality Management System Document like Change control, Deviation and their Investigations, CAPA and Audit Management. This role will focus on ensuring the highest standards of quality throughout the manufacturing process, specifically for active pharmaceutical ingredients
Monitoring for Documents compilation activities for New product filing , Re-Registration, renewals from plant dossier filing , sample requirements etc. Participation in Action plan discussion for queries from different Regulatory agencies and monitoring for submission of data/documents from plant.
Performing post-submission processing activities such as receiving acknowledgment from authority of submission receipt; capturing and the electronic receipt and metadata in RIM; communicating submission receipt to key stakeholders
Develop and maintain a comprehensive understanding of the company's products, particularly in the cardiovascular therapeutic area, while staying updated on the latest medical advancements, clinical guidelines, and treatment protocols.
Ciron has carved a niche for itself in the sphere of operations of manufacturing Ampoules, Vials, Eye / Ear / Nasal drops, Lyophilized products and Lyophilized bulk
To ensure compliance of computerized systems, PLC, SCADA-controlled equipment, and automation systems with regulatory requirements 21 CFR Part 11, EU Annex 11, GAMP 5, etc. by executing validation activities as per approved procedures and maintaining validated states throughout the system lifecycle.
Responsible for the quality of the multichannel digital content delivered to customers. Partner with all teams to understand and implement systemic controls wherever possible, across the software supply chain, from design till release. Explore and adopt quality improvement tools or methodologies.