Asst. Manager / Manager – Section Head (Validation / Qualification / CSV)
Pithampur, IndiaFull-timeSenior · 10-15 years
About this role
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