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
