Manager Analytical Method Validation

Rubicon Research Limited is a rapidly growing pharmaceutical formulation company focused on developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products in regulated markets. With a diverse product portfolio of over 250 SKUs spanning more than 70 product families, we have established marketing, sales, and distribution platforms in the US through our subsidiaries AdvaGen Pharma and Validus Pharmaceuticals. Our US FDA-inspected R&D facilities in India and Canada, along with manufacturing facilities in Maharashtra, India, equipped with various drug development and manufacturing capabilities, demonstrate our commitment to quality and innovation. As a Manager in Analytical Method Validation at Rubicon Research Limited, you will play a crucial role in overseeing end-to-end activities related to validation and documentation for various regulatory markets. Your responsibilities will include ensuring accurate documentation for analytical method validation, planning daily validation activities, coordinating with the Analytical Development team, reviewing protocols and reports, managing incidences, investigations, and change control processes, and ensuring compliance with quality management systems. Additionally, you will be responsible for training and supporting the Analytical Method Validation team, providing technical input for analytical data generation, addressing analytical issues, and preparing material budgets. Key Qualifications & Experience: - M. Pharm/M. Sc in Organic or Analytical Chemistry - Proficiency in handling instruments such as HPLC, GC, KF, IC, PSD, etc. - Familiarity with US, UK, EU, and ROW regulatory bodies - Experience with GDP and regulatory query handling In this role, you will need to demonstrate a strong understanding of regulatory guidelines, ensure compliance in the laboratory, provide technical training to team members, and review documents through the Document Management System (DMS) following the Quality Management System (QMS). Your expertise will be crucial in maintaining GLP standards, meeting regulatory and quality expectations, and ensuring that all analytical work is audit-ready to meet FDA standards. Please note that the candidate is expected to work in various shifts as required and may need to visit external sites based on project requirements. If you are passionate about pharmaceutical development, regulatory compliance, and analytical method validation, we encourage you to join our dynamic team at Rubicon Research Limited.,