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- Provide technical support to internal sites and CMOs, ensuring validated processes. - Act as technical expert during technology transfer and scaleup activities. - Apply science and riskbased approaches to maintain sustainable product quality. - Review and approve technical documentation (BMRs, Process Validation protocols/reports, Stability protocols/reports, risk assessments, validation documents, RA documents) for timely submission. - Execute and monitor batches, applying scaleup factors for process optimization. - Maintain oversight of CQAs, CMAs, and CPPs to ensure process robustness. - Support validation strategies, including protocol and report preparation. - Ensure products remain in a validated state through revalidation planning. - Collaborate crossfunctionally with Quality, Operations, Engineering, and Development. - Lead/support root cause investigations and drive remediation initiatives. - Provide documentation and data for product transfers and launches. - Travel 4070% to CMO locations across India and overseas for onsite support. - Ensure compliance with regulatory and quality standards during transfers. - Wruster coating experience will be considered an added advantage. - Postgraduate in Pharmacy/Biotech/Life Sciences. - Postgraduate in Pharmacy/Biotech/Life Sciences. - 58 years of relevant MSAT/OSD technology transfer experience. - Robust knowledge of regulatory guidelines (USFDA, EMA, ICH, SUPAC). - Proficiency in QbD, DoE, statistical analysis tools (e.g., Minitab) preferred. - Excellent communication and crossfunctional collaboration skills. - Fluent in English; regional language proficiency is an advantage. .