Overall Job Purpose:
• The QA CMO Supervisor is responsible for ensuring compliance to Quality guidelines and law for Sun Pharma’s biological product manufactured externally. This includes supporting the QA Manager CMO Biologics on quality related topics (License B application readiness, License B maintenance, CMO quality oversight and inspection readiness), commercial operations, in addition to on-time release of product. 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 Compliance to Quality (Chinese Health Authority Regulations and GMP) of the contract Manufacturer.
Major tasks & responsibilities:
• Support the CMO Quality oversight as required for license C application readiness.
• Supports the Quality oversight of the CMO remote or on site.
• 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 procedures like 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.
• Supports or Manages and maintain product specification in accordance with current marketing authorizations and ensure timely updated of applicable associated documentation in support for batch release and ensures adaptation by CMO.
• 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 of CMO and suppliers.
Key Performance Indicators/result areas
• License B Application readiness and maintain in compliance
• 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
• HBO or 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.