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

SAVA HEALTHCARE LIMITED; Indor; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

SAVA HEALTHCARE LIMITED is seeking a Manager – Section Head to lead the Validation, Qualification and CSV within QA at the Indore plant. The role demands strategic oversight of Validation Master Plan, resource management, and cross-functional collaboration to ensure cGMP compliance and readiness for domestic and international inspections.

The candidate should have 10–15 years in Pharmaceutical QA with at least 5 years in validation/qualification/CSV, and experience with USFDA, MHRA, EU-GMP, and

Qualifications

• Bachelor-level or higher in Pharmaceutical sciences (B.Pharm / M.Pharm / M.Sc.) as required for QA leadership.
• Strong knowledge of GMP, ICH Q8–Q10, GAMP 5, and regulatory expectations.
• Experience handling regulatory audits (USFDA, MHRA, EU-GMP, WHO, etc.).

Responsibilities

• Lead the Validation Master Plan and oversee all validation activities (Process, Cleaning, Equipment, Facility, CSV).
• Ensure audit readiness and regulatory compliance for USFDA, MHRA, EU-GMP, WHO, etc.
• Manage resources and workload of the validation team and drive continuous improvement.

Skills

Leadership

Documentation

Coordination

Risk-based validation

Education

B.Pharm / M.Pharm / M.Sc.

Job description

Job Title

Manager – Section Head (Validation / Qualification / CSV)

Location

Indore Plant

Department

Quality Assurance (QA)

Reports to

Head – Quality Assurance / Site Quality Head

Role Summary

We are seeking a highly experienced and self-driven professional to lead the Validation & Qualification section within the QA department. The incumbent will be responsible for overseeing end-to-end activities related to Process Validation, Cleaning Validation, Equipment & Facility Qualification, and Computer System Validation (CSV). This is a managerial role requiring strong cross-functional collaboration, team leadership, and audit readiness for domestic and international regulatory inspections.

Key Responsibilities

Strategic Planning & Oversight

• Lead the development and implementation of the site Validation Master Plan (VMP).
• Oversee all validation and qualification activities (Process, Cleaning, Equipment, Facility, CSV) to ensure compliance with cGMP and regulatory expectations.
• Allocate resources and manage workload for validation team to ensure timely execution.

Process & Cleaning Validation

• Review and approve process validation protocols and reports in line with lifecycle approach.
• Ensure cleaning validation activities meet regulatory expectations and site-specific risk assessments.
• Support risk-based re-validation and continued process verification programs.

Equipment / Facility / Utility Qualification

• Oversee IQ, OQ, PQ of new and existing equipment, HVAC systems, and utilities.
• Ensure periodic requalification and deviation handling.
• Review and approve all qualification documents and summary reports.

Computer System Validation (CSV)

• Ensure GxP software and computer systems are validated as per GAMP 5 and 21 CFR Part 11 requirements.
• Collaborate with IT, Engineering, and external vendors for new system qualification, periodic reviews, and change management.
• Review and approve CSV documentation (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 audits and inspections.
• Maintain robust document control and support data integrity compliance across systems.

Team Leadership & Development

• Lead a team of executives and senior executives in the validation function.
• Provide technical guidance, training, and performance feedback.
• Foster a culture of continuous improvement and compliance.

Candidate Profile

Qualification

B.Pharm / M.Pharm / M.Sc. (Life Sciences, Chemistry, Microbiology)

Experience

10–15 years in Pharmaceutical Quality Assurance, with minimum 5 years in handling validation/qualification/CSV independently

• Sound knowledge of GMP guidelines, ICH Q8–Q10, GAMP 5, and regulatory requirements
• Prior experience in handling regulatory audits (USFDA / MHRA / EU-GMP / WHO / ANVISA, etc.)

Desired Skills

• Strong leadership and decision-making capabilities
• Excellent documentation, communication, and cross-functional coordination skills
• Proficiency in QMS systems, validation documentation tools, and MS Office
• Problem-solving mindset with a focus on risk-based, data-driven validation

Employment Type

Full-Time

Position Level

Manager – Section Head

CTC

As per industry standards and candidate profile