Executive - IT Quality Assurance (ITQA)

Why This Role Matters

In pharmaceutical manufacturing, data integrity and validated computer systems are critical to regulatory compliance. IT Quality Assurance (ITQA) ensures that computerized systems used in production, quality control, laboratory, and ERP environments comply with GMP and data integrity guidelines.
At APDM Pharmaceuticals, the Executive / Sr. Executive – ITQA plays a key role in maintaining validated systems, ensuring audit readiness, and safeguarding electronic data across operations. This role directly supports regulatory compliance and operational reliability at the Sakodara, Gujarat facility.

Job Description

APDM Pharmaceuticals is seeking experienced professionals with 4 to 6 years of experience in ITQA or Computer System Validation (CSV) within the pharmaceutical industry. The selected candidate will be responsible for validation of computerized systems, documentation review, audit support, and ensuring compliance with regulatory expectations related to data integrity.
This position requires a strong understanding of GMP environments, validation lifecycle processes, and pharmaceutical IT systems.

Key Features of the Role

• Exposure to Computer System Validation (CSV) lifecycle
• Involvement in ERP, LIMS, QMS, and production system validation
• Participation in regulatory audits and inspections
• Hands-on experience in data integrity compliance
• Cross-functional coordination with IT, QA, QC, and Production
• Opportunity to grow within pharma compliance and validation domain

Responsibilities

• Perform validation of computerized systems as per GMP guidelines
• Prepare and review validation documents including URS, FS, DS, IQ, OQ, PQ
• Ensure compliance with data integrity principles (ALCOA+)
• Support periodic review and revalidation of systems
• Coordinate with IT and vendors during system implementation
• Maintain ITQA documentation and validation records
• Participate in internal and external audits
• Monitor system access control and backup procedures
• Ensure compliance with 21 CFR Part 11 and Annex 11 guidelines
• Assist in risk assessments related to computerized systems

Required Qualifications

• 4 to 6 years of experience in ITQA / CSV in pharmaceutical industry
• Strong knowledge of GMP and data integrity requirements
• Experience with ERP, LIMS, QMS, or similar systems
• Understanding of validation lifecycle and documentation standards
• Exposure to regulatory audits

Educational Requirements

• B.Sc/ B.Pharm– Mandatory
• Certification in Computer System Validation (preferred)
• Additional training in GMP or data integrity (advantageous)

Experience and Skills

• Knowledge of 21 CFR Part 11 and EU Annex 11
• Strong documentation and analytical skills
• Understanding of risk assessment methodologies
• Good coordination and communication skills
• Ability to manage multiple validation projects
• Detail-oriented and compliance-focused mindset
• Familiarity with pharmaceutical IT infrastructure

Salary Insights

• Performance-based increments
• Standard pharmaceutical industry benefits
• Career growth opportunities in compliance and validation leadership
Final compensation will depend on system exposure and validation expertise.

Company Overview

APDM Pharmaceuticals is a growing pharmaceutical company focused on delivering quality healthcare solutions and creating a healthier future. Operating from its plant in Sakodara, Gujarat, the company emphasizes regulatory compliance, data integrity, and operational excellence.
The organization provides a structured and compliance-driven environment for professionals in quality and validation functions.

FAQs

Q: Is CSV experience mandatory?
A: Yes, prior experience in Computer System Validation is essential.

Q: Will the role involve audit participation?
A: Yes, ITQA professionals are expected to support regulatory audits.

Q: Is pharma industry experience required?
A: Yes, experience in a regulated pharmaceutical environment is mandatory.

Q: What determines Executive vs. Senior Executive level?
A: Experience depth, independent handling of validation projects, and audit exposure.

Application Tips

• Clearly mention systems validated (ERP, LIMS, QMS, etc.)
• Highlight experience with 21 CFR Part 11 and Annex 11
• Quantify validation projects handled
• Mention audit exposure and compliance contributions
• Include documentation lifecycle experience (URS to PQ)
• Keep resume structured with a dedicated CSV / ITQA section