Job
Description
Job Description Off Targets Research Private Limited (OTRPL) is seeking a proactive and detail-oriented Quality Assurance Executive to support our fast-paced R&D operations , with a focus on complex injectable product development . This role is ideal for candidates with 2-4 years of experience in QA functions within pharmaceutical R&D , particularly those with exposure to method development, formulation development, and regulatory documentation for global markets. Key Responsibilities: Review and approval of analytical and formulation development documents (protocols, reports, notebooks, method validation reports, etc.) Oversight of R&D documentation practices to ensure compliance with internal SOPs and regulatory standards (cGMP, GLP, ICH, etc.) Support data integrity initiatives and routine internal QA audits within the R&D environment Assist in deviation and change control reviews during the development phase Ensure proper archiving and traceability of scientific records and batch documents Coordinate with cross-functional teams (formulation, analytical, regulatory) to ensure QA alignment from early development to exhibit batches Contribute to regulatory submission readiness (505(b)(2), ANDA, EU hybrid, etc.) Desired Candidate Profile: Qualification: B.Pharm / M.Pharm / M.Sc. (Pharmaceutical Sciences, Chemistry, or related field) Experience: 2 to 4 years in a pharmaceutical QA role, ideally within R&D or development-phase QA Familiarity with complex injectables is preferred Strong understanding of QA documentation practices , ICH guidelines, and R&D phase compliance Experience in working with method validation, formulation trials, and raw data review Detail-oriented, process-driven, and comfortable working in a collaborative R&D setting
