Senior Manager
5 days ago
About Our Client
Our client is among the top 10 pharmaceutical companies in India, with a global presence in over 100 countries.
Job Description
Lead and oversee the operational activities at DP/FG/Device Assembly CMO's; scheduling of batches, commercial manufacturing and testing of DP Responsible to achieve on-time in-full manufacturing of DP/FG/Device Assembly in compliance with approved dossiers in collaboration with Quality Assurance, Regulatory Affairs, and Analytical teams Serve as DP Subject Matter Expert (SME) on multidisciplinary CMC teams to ensure scientifically driven development and optimization of biological processes Review and approve master batch records, change controls, and deviations, CAPA to ensure GMP compliance and operational success Preparation and review of documents such as CPV reports, risk assessments, technical reports, validation documents, deviation reports and regulatory modules Responsible for Continuous Process Improvement and Process Optimization to reduce Cost of Goods Responsible for Tech Transfer and Process Validation into commercialization Plan and forecast budgets, analyzing variances for production and development testing and execute the day-to-day financial activities in accordance with procedures and contracts. The candidate will communicate across the organization to ensure key stakeholders are aware of project status, potential risks and their required action plans. Supporting post launch market surveillance of the product Other duties as assigned
The Successful Applicant
Education
, MS or degree in (bio) chemical engineering.
Professional Experience
Skills & Abilities
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