Asst. Manager / Manager – Section Head (Validation / Qualification / Csv)

Sava Healthcare

5+ years

Not Disclosed

India Indore

10 Jan. 12, 2026

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Assistant Manager / Manager – Section Head (Validation, Qualification, CSV)
Category: Quality Assurance / Pharmaceutical QA
Location: Indore, India
Job Type: Full-Time
Experience Required: 10–15 years (minimum 5 years handling Validation/Qualification/CSV independently)
Reports To: Head – Quality Assurance / Site Quality Head
Department: Quality Assurance (QA)

About the Role
We are seeking a highly experienced, self-driven professional to lead the Validation & Qualification section within our QA department at the Indore pharmaceutical manufacturing facility. The role encompasses end-to-end oversight of Process Validation, Cleaning Validation, Equipment & Facility Qualification, and Computer System Validation (CSV). This leadership position requires strong cross-functional collaboration, audit readiness, and team management skills to ensure compliance with global regulatory standards including USFDA, MHRA, EU-GMP, WHO, and other authorities.

Key Responsibilities

Strategic Planning & Oversight

Lead the development and execution of the site Validation Master Plan (VMP).
Oversee all validation and qualification activities to ensure compliance with cGMP and regulatory requirements.
Allocate resources and manage validation team workload to meet project timelines.

Process & Cleaning Validation

Review, approve, and execute process validation protocols and reports following lifecycle and risk-based approaches.
Ensure cleaning validation activities meet regulatory and site-specific standards.
Support continued process verification and risk-based revalidation programs.

Equipment / Facility / Utility Qualification

Oversee IQ, OQ, PQ of new and existing equipment, HVAC systems, and utilities.
Ensure periodic requalification, deviation handling, and compliance with documentation standards.
Review and approve all qualification protocols, execution reports, and summary documents.

Computer System Validation (CSV)

Ensure validation of GxP software and computer systems in accordance with GAMP 5 and 21 CFR Part 11.
Collaborate with IT, Engineering, and external vendors for system qualification, periodic reviews, and change control.
Review and approve CSV documentation including URS, RA, IQ/OQ/PQ.

Compliance & Audit Readiness

Ensure all validation activities are audit-ready and compliant with USFDA, MHRA, EU-GMP, WHO, and other regulatory guidelines.
Lead responses to regulatory queries and participate in internal and external audits.
Maintain robust document control and support data integrity compliance.

Team Leadership & Development

Lead, mentor, and develop a team of executives and senior executives in the validation function.
Provide technical guidance, training, and performance feedback.
Promote a culture of continuous improvement, compliance, and risk-based decision making.

Candidate Profile

Educational Qualification:

B.Pharm / M.Pharm / M.Sc. in Life Sciences, Chemistry, or Microbiology.

Experience Required:

10–15 years in Pharmaceutical Quality Assurance.
Minimum 5 years managing Validation/Qualification/CSV independently.
Hands-on experience with USFDA, MHRA, EU-GMP, WHO, and other regulatory audits.

Desired Skills:

Strong leadership, decision-making, and cross-functional coordination skills.
Excellent documentation, communication, and team management capabilities.
Proficiency in QMS systems, validation documentation tools, and MS Office.
Analytical and problem-solving mindset with a focus on risk-based, data-driven validation.
In-depth knowledge of GMP, ICH Q8–Q10, and GAMP 5.

Employment Type: Full-Time
Position Level: Manager – Section Head
CTC: Competitive, based on industry standards and candidate profile

Why Join Us
This is a high-impact leadership role offering an opportunity to shape the validation and QA strategy within a regulated pharmaceutical environment. You will lead critical compliance activities, mentor a skilled team, and contribute to global audit readiness and quality excellence.

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Asst. Manager / Manager – Section Head (Validation / Qualification / Csv)

Job Description

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