Officer / Sr.Officer / Executive - CMO QA

Role & responsibilities

• To be well versed about coordination and collaboration with Quality functions of third party manufacturing (CMO) sites and CMO team for compliance of product, facility, systems, procedures. and for documents required from third party for various purpose; review, RA submission etc.
• Must have knowledge and know how on regulatory pathway for registration of product as per third party and or loan license norms/rules and requirement of documentation for regulatory submissions. Incumbent is expected a good reviewer and investigator
• To know the function of oversight of CMO sites for batch/lot releases as applicable form the manufacturing (Feed supplements and Pharma products facilities for update on compliance of system, procedure, systems)
• To be well versed with vendor qualification procedures and must be experienced in conducting audits/inspections at CMO sites for qualification and compliance
• To verify CoA for in line with product specifications and CoA.
• To verify and to confirm stability study of finished products and to coordinate for documents of stability, RM, PM, product specifications, CoA.
• To identify Govt. approved third party labs for testing of RM, PM (if any) and finished product and to support CMO-QA for Qualification of vendor (Third party lab/service provider)
• To review batch documents and test analysis reports of batches /lots executed in line with established batch formula and test method/product specification
• To be well versed and possessing know how of establishing Quality Function (QA & QC) for CMO Function
• To perform investigation related to product complaints, observations/notices and to collaborate and coordinate with CMO function and Quality function of third party manufacturing site for root cause analysis and CAPA actions
• To possess knowledge on quality management system such as change management, complaint handling, CAPA procedures, recall procedures, regulatory queries responding and handling of queries from customers and market.
• To be well versed with procedures of artwork (PPI & label etc.) preparation, review and approval
• To have very good operational knowledge of computer: Microsoft word, excel and any other software based task related to CMO-QA function
• To coordinate with sourced lab and third party manufacture for timely completion of testing of routine batch(s) and testing of samples as part of investigation and for timely responses on queries and product complaints
• To possess very good communication skills, willing to travel as part of job role

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