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

SAVA Group; Indor; On-site; INR 700,000 - 1,100,000; Full time

Job summary

SAVA Group is seeking an Executive / Senior Executive – QA (Validation & Qualification) to bolster our Quality Assurance team in the Rajasthan facility. The role focuses on Validation activities across PV, Cleaning and CSV, supporting cross-functional validation projects.

Eligible candidates have 2–6 years in regulated pharma environments, with GMP/ICH/USFDA exposure and strong documentation skills; flexibility to coordinate with Production, QA, QC, Engineering and IT teams.

Qualifications

• Qualified candidates with GMP/ICH/WHO/USFDA exposure preferred.
• Experience in regulated pharmaceutical environments is essential.
• Hands-on in validation activities across PV, Cleaning, Equipment Qualification or CSV.

Responsibilities

• Prepare and review PV protocols and reports; coordinate validation batches with cross-functional teams.
• Develop and execute cleaning validation protocols; review data and MACO/residue limits.
• Support IQ/OQ/PQ for equipment, systems and utilities; maintain reports for audits.
• Prepare URS/RA/IQ/OQ/PQ for GxP systems and ensure data integrity and change control.

Skills

Validation lifecycle

Risk-based approach

Documentation & data review

Cross-functional coordination

Audit readiness & regulatory

MS Office & documentation systems

Education

B.Pharm / M.Pharm / M.Sc. (Life Sciences / Chemistry / Microbiology)

Tools

MS Office

Job description

2 to 6 Years

Full-Time

Job Title: Executive / Senior Executive – QA (Validation & Qualification)

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.

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