Executive/ Sr. Executive- Quality Assurance (Validation)

SAVA Group; Surendranagar; On-site; INR 700,000 - 1,200,000; Full time

Job summary

SAVA Group in India invites applications for Executive/Sr. Executive-Quality Assurance (Validation) to plan, execute, and document validation activities across processes, equipment qualification, cleaning, utilities, and CSV where applicable.

Prepare, review, and approve validation protocols, reports, and SOPs, ensuring compliance with cGMP, WHO, USFDA and EU-GMP guidelines. Strong validation knowledge preferred for mid-senior roles.

Qualifications

• Education and validation knowledge required.
• 2–6 years QA Validation experience in pharma/API/manufacturing.
• Familiarity with regulatory guidelines (WHO, USFDA, EU-GMP).
• Strong GMP and validation principles.
• Hands-on validation documentation experience.

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); CSV, if applicable.
• Process Validation
• Equipment Qualification (DQ, IQ, OQ, PQ)
• Cleaning Validation
• Utility Validation (HVAC, Water Systems, Compressed Air)
• 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.

Skills

GMP knowledge

Validation documentation

Analytical skills

Communication skills

MS Office

Education

B.Pharm

M.Pharm

B.Sc

M.Sc

B.E

B.Tech

Tools

MS Office

Job description

Executive/ Sr. Executive- Quality Assurance (Validation)

3-7

Full-Time

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

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