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
