Executive/ Sr. Executive- Quality Assurance (Validation)

Job highlights

• 6 years of experience in QA Validation (pharma / API/manufacturing). Freshers with strong validation knowledge may be considered for junior roles
• Required Qualifications
• Required Skills

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

Required Skills

assurance QA Validation

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