Executive/ Sr. Executive- Quality Assurance (Validation)

Key Responsibilities

Plan, execute, and document validation activities including

Process Validation

Equipment Qualification (DQ, IQ, OQ, PQ)

Cleaning Validation

Utility Validation (HVAC, Water Systems, Compressed Air)

Computer System Validation (CSV), if applicable

Process Validation

Equipment Qualification (DQ, IQ, OQ, PQ)

Cleaning Validation

Utility Validation (HVAC, Water Systems, Compressed Air)

Computer System Validation (CSV), if applicable

Prepare, review, and approve validation protocols, reports, and SOPs.

Ensure validation activities comply with cGMP, WHO, USFDA, EU-GMP guidelines.

Conduct risk assessments (FMEA, risk-based validation approaches).

Handle deviations, change controls, and CAPA related to validation.

Support internal and external audits and regulatory inspections.

Coordinate with Production, Engineering, QC, and IT teams for validation activities.

Maintain validation master plan (VMP) and ensure timely execution.

Ensure data integrity and documentation accuracy as per ALCOA principles.

Required Qualifications

Education

B.Pharm / M.Pharm / B.Sc / M.Sc / B.E / B.Tech (relevant discipline)

Experience

2–6 years of experience in QA Validation (pharma/API/manufacturing)

Freshers with strong validation knowledge may be considered for junior roles

Skills & Competencies

Strong knowledge of GMP and validation principles

Hands-on experience with validation documentation

Familiarity with regulatory guidelines (WHO, USFDA, EU-GMP)

Good analytical, problem-solving, and communication skills

Ability to work independently and in cross-functional teams

Proficiency in MS Office and documentation practices