Executive / Senior Executive – QA (Validation/Qualification/IPQA/Lab QA)

Job Description

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. Process Validation Key Responsibilities (based on area of expertise): 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 Show more Show less