Job Title: Executive / Senior Executive – QA (Validation & Qualification) Location: Indore Plant Department: Quality Assurance (QA) Reports to: QA Manager – Validation / Head QA Role Summary: We are looking for dedicated and experienced professionals to join our Quality Assurance (QA) Department as Executive / Senior Executive. The role involves supporting Validation & Qualification activities in any of the following areas: • Process Validation • Cleaning Validation • Facility & Equipment Qualification • Computer System Validation (CSV) Candidates with hands-on experience in one or more of these areas are encouraged to apply. Key Responsibilities (based on area of expertise): Process Validation: • Prepare and review Process Validation Protocols and Reports (PV). • Coordinate validation batches with cross-functional teams. • Monitor critical process parameters and ensure adherence to approved specifications. • Perform risk assessments and gap analysis as required. Cleaning Validation: • Develop and execute cleaning validation protocols and sampling plans. • Perform visual inspection and swab/rinse sampling for various equipment. • Review analytical data and calculate MACO/Residue Limits. • Maintain cleaning validation matrix and revalidation schedules. Facility & Equipment Qualification: • Support IQ, OQ, PQ of equipment, systems, and utilities as per validation master plan. • Participate in installation, commissioning, and qualification activities. • Ensure periodic qualification and requalification as per schedule. • Maintain GMP-compliant records and reports for audits and inspections. Computer System Validation (CSV): • Prepare and review URS, RA, IQ/OQ/PQ protocols for GxP systems. • Ensure compliance with 21 CFR Part 11, GAMP 5, and data integrity principles. • Coordinate with IT, QA, and software vendors during validation life cycle. • Maintain validation documentation and change control records. Candidate Profile: Qualification: B.Pharm / M.Pharm / M.Sc. (Life Sciences / Chemistry / Microbiology) Experience: 2–6 years in regulated pharmaceutical / API / sterile manufacturing environments • Exposure to GMP, ICH, WHO, USFDA, and other regulatory guidelines is essential • Experience in one or more of the following: Process Validation, Cleaning Validation, Equipment Qualification, or CSV Desired Skills: • Strong understanding of validation life cycle and risk-based approach • Good documentation and data review skills • Ability to coordinate with cross-functional teams (Production, QA, QC, Engineering, IT) • Audit readiness and familiarity with regulatory expectations • Proficiency in MS Office and documentation systems Employment Type: Full-Time CTC: As per industry norms and candidate’s experience