Overall Job Purpose:
• The QA CMO Supervisor is responsible for ensuring compliance in Sun Pharma’s biological product manufactured externally. This includes supporting the QA Manager CMO Biologics on Quality System development (license B application readiness), commercial operations, in addition to on-time release of product and appropriate maintenance of local quality systems. He/she ensures that activities at Contract Manufacturing Organizations are conducted according to the relevant Standard Operating Procedures aligned with the Quality Assurance Agreement. Supports in the maintenance of the QMS to align with Health Authority Regulations.
Major tasks & responsibilities:
• Support the creation and maintenance of Quality Systems required for license B application readiness.
• Supports the interpretation of regulatory requirements in to SOP´s
• Support the timely implementation of global standards and procedures in to the local QMS which may involve execution of gap assessments against local procedures.
• Manages (Initiates, investigates and ensures timely closures) key quality systems and product related deviations, change controls, CAPAs, complaints by liaising with CMO’s and other Sun stakeholders.
• Assess, based on risk management tools and thorough and good understanding of manufacturing operations, change controls, deviations and complaints while ensuring proper implementation in marketing authorizations of changes proposed by different stakeholders.
• Manages and maintain product specification in accordance with current marketing authorizations and ensure timely updated of applicable associated documentation in support for batch release.
• Review of batch documentation in preparation for batch release and to ensure compliance with GMP and with the marketing authorizations
• Supports technology transfers and process/ analytical method validation activities from quality operations perspective when required.
• Preparation of annual product reviews (APR/PQR).
• Support planning and execution of external and internal audits
Key Performance Indicators/result areas
• License B Application readiness
• On time batch release
• First time right of batch documentation review
• In time management and closure of significant quality events, change controls, complaints, deviations etc.
• On time preparation of APR/PQR.
• On time support of new projects.
Qualifications, Knowledge, Experience & Skills
Education Qualifications (Graduate- Post Graduate) Mandatory
• Bachelor Degree in (Bio-) Chemistry, Pharmacy, Biotechnology or similar education.
• Minimum of 5 years of relevant experience in (bio) pharmaceutical Drug Substance and/or Drug Product manufacturing.
• Strong knowledge of Chinese GMP, EU GMP, US CFRs.
• Well versed in Microsoft Excel.
• Competency in English
Preferred:
• MSc on (Bio-) Chemistry, Pharmacy, Biotechnology or similar education.