Manager

• Responsible for lifecycle management of development products with respect to knowledge management and lifecycle management as per ICH. Management of process changes in early phase development
• Review of clone development and cell banking documentation and ensuring regulatory compliance in plans and reports
• Review of product development documents such as process development reports, process descriptions, process control strategy documents etc.
• Review of analytical developments such as method development reports, method qualification/validation protocols and reports and ensure compliance as per latest quality and regulatory requirements
• Development, Implementation and continual improvement of Quality Management System at R&D through SOPs, Manuals, training and audits and ensuring alignment with corporate QA and site QA.
• Verification of Laboratory data and its integrity, ensuring good documentation practices and data reporting as per ALCOA++
• Compilation and review of process and analytical documents for regulatory filing and CMC review
• Control of documents, issuance of working copies, verification of raw data and archival of soft and hard copy documents based on ALCOA+ principles.
• Knowledge on regulatory requirements on Biosimilar and biologics product specially USFDA, EMEA, Japan and India etc.
• Experience in dossier writing for various countries such as USFDA, EMEA and India etc.

Key responsibility would be to ensure Dossier writing, Audit readiness at all times and defending QMS and ability to respond to Audit queries from Regulatory agencies, Clients and business partners.

Education and Experience:

• MSc in life sciences / M. Pharm (Quality)
• Minimum experience of 10 - 15 years in quality assurance
• Good understanding of regulatory guidelines (RCGM, CDSCO, ICH and ISPE)
• Exposure of product development, analytical development, CMC, regulatory filing, RCGM and CDSCO requirements for recombinant products. Exposure of filing in regulated markets (EMA/FDA/PMDA/TGA/HC/ANVISA) would be preferred.
• Exposure to lifecycle management for global product development would be added advantage.
• Experience of having faced international inspections / audits from Regulatory agencies, Clients and business partners is preferred.
• Excellent skill of Verbal and Written communication in English is necessary.
• Experience of Dossier writing.