This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
To participate in meetings with cross functional teams like Analytical, Regulatory, Quality, manufacturing, Contract Manufacturing Organization (CMO), Project management, Characterization team for on time review support
To participate in meetings with Contract Manufacturing Organizations (CMOs) & Contract Research Organizations (CROs) & contract Labs for on-time review support
Responsible for tech transfer meetings with External Site as a core team member from quality for analytical discussion
To review, approve and ensure Technology Transfer/Validation/Verification/Post- production studies documents to respective plants
To be a part of investigations and to perform investigations extensively to derive root cause and its corrective measures and preventive actions
Quality SME for risk analysis of GPRD studies
To review and approve change controls, NCR/SNCR, CAPA, Effectiveness checks, etc
To carry out internal quality audits and perform GEMBA walks of R&D labs for compliance & betterment as per current regulations and GLP (Good Laboratory Practice)
To impart training to R&D team members on various aspects of GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) guidelines and practices
To ensure that the development is carried out as per the latest QBD (Quality by Design) and PDLM concepts
To review ADL documents like specifications, method of analysis, method development, method validations, method transfer reports, stability sheets and ensure compliance as per ICH (International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) and filing requirements as and when required.
Requirements
Having a good knowledge of injectable formulation - peptide/liposomes and complex generic molecules
Having a good knowledge of product development and life cycle management
Having a good knowledge of critical analytical techniques like LCMS, GCMS, HPLC, GC, IC etc
Having a good knowledge of regulatory requirements for ANDA/NDA submissions
Having good experience of responding regulatory queries
Having good critical thinking ability to challenge and resolve the technical concerns related to submission studies
To participate in meetings with cross functional teams like Analytical, Regulatory, Quality, manufacturing, Contract Manufacturing Organization (CMO), Project management, Characterization team for on time review support
To participate in meetings with Contract Manufacturing Organizations (CMOs) & Contract Research Organizations (CROs) & contract Labs for on-time review support
Responsible for tech transfer meetings with External Site as a core team member from quality for analytical discussion
To review, approve and ensure Technology Transfer/Validation/Verification/Post- production studies documents to respective plants
To be a part of investigations and to perform investigations extensively to derive root cause and its corrective measures and preventive actions
Quality SME for risk analysis of GPRD studies
To review and approve change controls, NCR/SNCR, CAPA, Effectiveness checks, etc
To carry out internal quality audits and perform GEMBA walks of R&D labs for compliance & betterment as per current regulations and GLP (Good Laboratory Practice)
To impart training to R&D team members on various aspects of GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) guidelines and practices
To ensure that the development is carried out as per the latest QBD (Quality by Design) and PDLM concepts
To review ADL documents like specifications, method of analysis, method development, method validations, method transfer reports, stability sheets and ensure compliance as per ICH (International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) and filing requirements as and when required.