Job Title: Executive / Senior Executive – Quality Assurance (Validation, Qualification, IPQA, Lab QA)
Category: Quality Assurance / Pharmaceutical QA
Location: Indore, India
Job Type: Full-Time
Experience Required: 2–6 years
Reports To: QA Manager – Validation / Head QA
Department: Quality Assurance (QA)
About the Role
Our Indore-based regulated pharmaceutical manufacturing facility is seeking experienced Executive / Senior Executive – QA professionals to support Validation and Qualification activities across multiple domains. This role offers exposure to process validation, cleaning validation, facility and equipment qualification, and computer system validation (CSV) within a cGMP-compliant environment.
Candidates with hands-on experience in one or more of these QA domains are encouraged to apply.
Key Responsibilities
Process Validation (PV):
Prepare, review, and execute Process Validation protocols and reports.
Coordinate validation batches with cross-functional teams.
Monitor critical process parameters and ensure compliance with approved specifications.
Conduct risk assessments and gap analyses to support validation activities.
Cleaning Validation (CV):
Develop, execute, and document cleaning validation protocols and sampling plans.
Conduct visual inspections and swab/rinse sampling of equipment.
Analyze data and calculate Maximum Allowable Carry Over (MACO) or residue limits.
Maintain cleaning validation matrix, revalidation schedules, and compliance records.
Facility & Equipment Qualification:
Support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of equipment, systems, and utilities.
Participate in commissioning, qualification, and periodic requalification activities.
Maintain GMP-compliant records for audits, inspections, and regulatory submissions.
Computer System Validation (CSV):
Prepare and review User Requirements Specifications (URS), Risk Assessments (RA), and IQ/OQ/PQ protocols for GxP systems.
Ensure compliance with 21 CFR Part 11, GAMP 5, and data integrity principles.
Collaborate with IT, QA, and software vendors during the validation lifecycle.
Maintain validation documentation and change control records.
Candidate Profile
Educational Qualification:
B.Pharm / M.Pharm / M.Sc. in Life Sciences, Chemistry, or Microbiology.
Experience Required:
2–6 years in regulated pharmaceutical, API, or sterile manufacturing environments.
Practical exposure to GMP, ICH, WHO, USFDA, and other regulatory guidelines.
Hands-on experience in one or more areas: Process Validation, Cleaning Validation, Equipment Qualification, or CSV.
Desired Skills:
Strong understanding of validation lifecycle and risk-based approach.
Excellent documentation, data review, and analytical skills.
Ability to coordinate effectively with cross-functional teams (Production, QA, QC, Engineering, IT).
Audit readiness and familiarity with regulatory inspections.
Proficiency in MS Office and electronic documentation systems.
Employment Type: Full-Time
CTC: Competitive, based on industry norms and candidate experience
Why Join Us
This is a strategic opportunity to advance your QA career in a regulated pharmaceutical environment, gaining hands-on experience in validation and qualification processes while contributing to regulatory compliance and product quality.
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