L 7 To L 6– QA (Validation/Qualification/IPQA/Lab QA)

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