Quality Assurance Specialist

Cook N Klean; Ludhiana; On-site; INR 600,000 - 900,000; Full time

Job summary

Cook N Klean in Ludhiana, Punjab, is seeking a QA Executive/Manager for Equipment Validation. The role requires 3–5 years in QA/Validation, preferably in sterile/injectable manufacturing, and involves planning, reviewing, and executing qualification activities to ensure GMP compliance.

You will coordinate qualification of manufacturing equipment, review validation documents and CAPA, and support audits. The position requires a strong grasp of regulatory guidelines and data integrity, with

Qualifications

• 3–5 years in QA/Validation, preferably in sterile/injectable manufacturing.

Responsibilities

• Prepare, review, and approve URS, DQ, IQ, OQ, PQ, and validation protocols/reports.
• Coordinate qualification of manufacturing and utility equipment used in injectable/sterile operations.
• Review validation documents, deviations, change controls, and CAPA related to qualification activities.
• Ensure compliance with GMP, regulatory guidelines, SOPs, and data integrity requirements.
• Coordinate with Engineering, Production, QC, and QA for qualification and validation activities.
• Support internal, customer, and regulatory audits related to equipment qualification.
• Maintain validation documentation and ensure timely completion of validation schedules.
• Participate in risk assessments and periodic review/requalification activities.

Skills

RM Testing

SPEC

COA

Equipment Qualification

IQ/OQ/PQ

URS/DQ

GMP

Validation Documentation

Risk Assessment

Change Control

Deviation/CAPA

Sterile/Injectable Manufacturing

Audit Readiness

Education

B.Pharm / M.Pharm / B.Tech / M.Tech or equivalent

Job description

Job Description – QA Executive/Manager – Equipment Validation

Position: QA – Equipment Validation

Department: Quality Assurance

Industry: Pharmaceutical – Injectable

Experience: 3–5 years in QA/Validation, preferably in sterile/injectable manufacturing

Job Purpose

Responsible for planning, reviewing, and executing equipment qualification and validation activities to ensure compliance with GMP and regulatory requirements.

Key Responsibilities

• Prepare, review, and approve URS, DQ, IQ, OQ, PQ, and validation protocols/reports.
• Coordinate qualification of manufacturing and utility equipment used in injectable/sterile operations.
• Review validation documents, deviations, change controls, and CAPA related to qualification activities.
• Ensure compliance with GMP, regulatory guidelines, SOPs, and data integrity requirements.
• Coordinate with Engineering, Production, QC, and QA for qualification and validation activities.
• Support internal, customer, and regulatory audits related to equipment qualification.
• Maintain validation documentation and ensure timely completion of validation schedules.
• Participate in risk assessments and periodic review/requalification activities.

Qualification

B.Pharm / M.Phirm / B.Tech / M.Tech or equivalent relevant qualification.

Key Skills

RM Testing, SPEC, COA , Equipment Qualification, IQ/OQ/PQ, URS/DQ, GMP, Validation Documentation, Risk Assessment, Change Control, Deviation/CAPA, Sterile/Injectable Manufacturing, Audit Readiness