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:

• Process Validation
• Cleaning Validation
• Facility & Equipment Qualification
• Computer System Validation (CSV)

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:

• 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