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

SAVA HEALTHCARE LIMITED; Indore District; On-site; INR 500,000 - 750,000; Full time

Job summary

SAVA HEALTHCARE LIMITED in Indore invites applications for Executive / Senior Executive – QA (Validation & Qualification). You will support Validation & Qualification activities across PV, Cleaning Validation, Equipment Qualification, and CSV, collaborating with cross‑functional teams.

Candidates with 2–6 years in regulated pharma, exposure to GMP/ICH/USFDA, and a degree in B.Pharm / M.Pharm / M.Sc. are encouraged to apply. Full‑time role with development opportunities in QA.

Qualifications

• 2–6 years of experience in regulated pharmaceutical environments.
• Exposure to GMP, ICH, WHO, USFDA or other regulatory guidelines.
• Experience in one or more of: Process Validation, Cleaning Validation, Equipment Qualification, or CSV.

Responsibilities

• Prepare and review Process Validation Protocols and Reports.
• Coordinate validation batches with cross‑functional teams.
• Monitor critical process parameters and ensure adherence to specifications.
• Perform risk assessments and gap analysis as required.
• Develop and execute cleaning validation protocols and sampling plans.
• Review analytical data and maintain cleaning validation matrix and revalidation schedules.
• Support IQ, OQ, PQ of equipment, systems, and utilities.
• 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.
• 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.

Skills

Validation life cycle

Documentation & data review

Cross-functional coordination

Audit readiness

MS Office proficiency

Education

B.Pharm / M.Pharm / M.Sc.

Tools

MS Office

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