Analyst - Formulation Analytical R&D

Roles & Responsibilities
• Support Analytical Development activities in line with the New Product Development (NPD) plan
• Coordinate with FR&D, Production, QA, and Validation teams to ensure timely execution of R&D stability batches for regulatory approvals
• Perform and manage HPLC and GC analysis, including review of analytical test methods and development reports
• Review specifications, STPs, calibration records, COAs, elemental impurities assessments, and residual solvent declarations
• Plan daily laboratory activities and approve Analytical Test Requests (ATRs)
• Ensure compliance of laboratory instruments including calibration, re-qualification, and preventive maintenance
• Conduct stability studies and evaluate data for regulatory submissions
• Perform method validation as per USP and ICH guidelines to meet regulatory requirements
• Investigate OOS, OOT, and incident-related analytical issues and review investigation reports
• Maintain traceable documentation of all analytical records and review audit trails for generated data
• Align AR&D activities with project timelines and FR&D requirements to ensure goal fulfillment
• Liaise with internal stakeholders to resolve analytical challenges, including complex or sensitive matters
• Ensure workplace safety and adherence to GMP, GLP practices
• Participate in technical training programs and support continuous improvement initiatives within the department

Qualification
• Master’s degree or equivalent in Pharmaceutical Sciences, Chemistry, Pharmacy, or Life Sciences
• Master's of Pharmacy

Experience
• 3+ years of experience in Analytical Research & Development in the pharmaceutical industry
• Experience working in a generic pharmaceutical company
• Hands-on experience in method development and validation for oral solid dosage forms

Skills
• Strong knowledge of impurities quantification and analytical techniques
• Proficiency in HPLC, GC, and related analytical instrumentation
• Sound understanding of GMP, GLP, and regulatory requirements
• Strong documentation and data integrity awareness
• Good analytical and problem-solving skills
• Effective interpersonal and cross-functional coordination abilities
• Ability to manage multiple projects within defined timelines

About the Organization
Granules India Limited is a vertically integrated pharmaceutical company engaged in the manufacturing of APIs, pharmaceutical formulation intermediates, and finished dosage forms. With globally approved manufacturing facilities, including its Gagillapur Plant in Hyderabad, Granules India Limited is committed to quality, compliance, and innovation, supplying affordable medicines to regulated and semi-regulated markets worldwide.