Development quality assurance Manager

Role & responsibilities

• Provide proper guidance on quality issues to the process development team.
• Responsible for approval of process development and process modification reports and ensure proper stage gate compliance at every stage of product along with technology transfer.
• Review the process change proposals and provide guidance on change proposals.
• Handling of vendor qualification activity.
• Should have knowledge on spike and purge studies and purge factors as per regulatory requirements.
• Responsible for review and approval of Analytical method validation, method transfer and method verification protocols & reports.
• Responsible for review of method development reports.
• Responsible for review and approval of Stability & Holding Study analysis data.
• Responsible for review and approval of equipment qualification /calibration/ validation reports (IQ, OQ, PQ) related to all analytical instruments.
• Responsible for review and approval of Specifications & Standard test procedures.
• Responsible for review and approval of reference standard and impurity COAs and characterization data.

Preferred candidate profile

• Should have knowledge of GTI & Nitrosamines risk assessment.
• Should have good knowledge of ICH guidelines, USP general chapters.
• Should have strategic thinking and problem-solving skills.
• Handling of QMS activity (Incidents, Change controls, OOS & Deviations).
• Should have knowledge of SOP preparation.
• Responsible for review of Empower and other analytical instruments audit trails.
• Responsible for maintaining GLP & GDP at workplace.
• Develop training content and deliver training to staff on Quality topics, QA orientation and applicable in-house procedures.
• Responsible for internal audits, customer & agency audits, timely release of audit reports and ensure adequate response to the audit observations.
• Excellent written and verbal communications skills.