Associate Scientist DQA

Lupin; Pune District; On-site; INR 1,100,000 - 1,700,000; Full time

Job summary

Lupin is seeking a GMP-literate professional to lead ADC lab setup and qualification in Pune. You will implement SOPs, ensure GMP compliance, and manage analytical method transfers, documentation, and change controls.

The role requires collaboration with clients and vendors to adopt best practices and maintain audit readiness. The incumbent will review and approve analytical methods, stability protocols, and instrument qualifications, and oversee lab rounds to ensure timely closure of

Responsibilities

• Experience in handling payload linker and ADC molecules and support to establish the ADC lab and ensure the qualification of ADC lab including equipment qualification, calibration and AMC to meet GMP requirements.
• Implement SOP procedures and guidelines as per requirement.
• Experience in handling Peptides & HPAPI/Oncology molecules and ensure to meet GMP requirements.
• Ensure quality and compliance, audit readiness to meet GMP & regulatory requirements.
• Drive product and service quality by collaborating with clients, vendors and industry experts to adopt best practices and new technologies.
• Review and approval of the process-related documents.
• Review and approval of analytical related documents such as raw material, in-process, intermediate, drug substance specification and Standard Test Procedures; review and approval of stability study protocol/hold time stability protocol, etc.
• Prepare and update product review checklist for drug substance.
• Review and approval of Analytical Method Transfer Protocols and waivers.
• Ensure pharmacopeial updation of drug substances for specification limits and method of analysis against current official monograph.
• Review and management of Change control, Deviation and CAPA to avoid delays in technology transfer and regulatory filing.
• Review and compliance of different online records and analytical data without deviation and provide inputs as applicable.
• Review and approval of protocols and reports of Analytical Method Validations of drug substance, Starting Materials and intermediates.
• Review and approval of protocols and reports of Analytical Method Equivalence of drug substance and other query related data.
• Review and approval of instrument and equipment hardware qualification.
• Review and approval of SOP and guideline of Analytical Research & Development department.
• Performing Lab rounds and sharing observations to cross functional team and follow up for their closure.

Job description

Role & responsibilities

• 1. Experience in handling of payload linker and ADC molecules and Support to establish the ADC lab and ensure the Qualification of ADC lab including equipment qualification, calibration and AMC to meet the GMP requirements.
• 2. Implement the SOP procedures and guidelines as per the requirement.
• 3. Experience in handling of Peptides &HPAPI/Oncology molecules and ensure to meet the GMP requirements .
• 4. Ensure Quality and compliance, audit readiness to meet the GMP & Regulatory requirements.
• 5. Drive product and service quality by collaborating with clients, vendors and industry experts to adopt the best practices and new technologies.
• 6. To review and approval of the process related documents .
• 7. To review and approval of analytical related documents such as raw material, in-process, intermediate, drug substance specification and Standard Test Procedures. To review and approval of stability study protocol/ hold time stability protocol etc.,
• 8. To prepare and update product review checklist for drug substance.
• 9. Review and approval of Analytical Method Transfer Protocols and waivers.
• 10. To ensure pharmacopeial updation of drug substances for specification limits and method of analysis against current official monograph.
• 11. To review and management of Change control, Deviation and CAPA to avoid any delay in technology transfer and regulatory filing.
• 12. To review and compliance of different online records and analytical data without any deviation and provide inputs as applicable.
• 13. Review and approval of protocols and reports of Analytical Method Validations of drug substance, Starting Materials and intermediates.
• 14. Review and approval of protocols and reports of Analytical Method Equivalence of drug substance and other query related data etc.
• 15. To review and approval of instrument and equipment hardware qualification.
• 16. To review and approval of SOP and guideline of Analytical Research & Development department.
• 17. Performing Lab rounds and sharing observations to cross functional team and follow up for their closure