Job Description

Key Responsibilities:

Develop and execute

User Requirement Specifications (URS)

,

Design Qualification (DQ)

,

Installation Qualification (IQ)

,

Operational Qualification (OQ)

, and

Performance Qualification (PQ)

documents. Perform qualification of process equipment, utilities, laboratory instruments, and facility systems. Coordinate with engineering, production, and quality teams for equipment readiness. Review vendor documents and validation packages. Ensure documentation complies with

cGMP

,

21 CFR Part 11

, and other regulatory guidelines. Support audits and provide technical responses for qualification-related observations. Maintain equipment qualification status and change control documentation.

Requirements:

Bachelor's or Master's degree in

Pharmacy

,

Biotechnology

,

Engineering

, or related field. Minimum

3-10 years

of experience in

equipment qualification / validation

in a regulated pharma or biotech setup. Strong understanding of

GMP

,

GDP

, and regulatory expectations (FDA, EMA, WHO). Hands-on experience in qualification of manufacturing, utility, and analytical equipment. Excellent documentation and communication skills.

Preferred Skills:

Experience with

CSV (Computer System Validation)

. Exposure to

cleanroom qualification

and

HVAC system validation

. Knowledge of

risk-based qualification

and

validation lifecycle approach

.
Job Types: Full-time, Permanent, Freelance
Contract length: 3 months

Pay: ?400,000.00 - ?800,000.00 per year

Work Location: In person