Company Name: VARITE India Private Limited

About The Client:

A global professional services network and part of the Big Four, along with Client, EY, and KPMG, operating across 149 countries worldwide.

Essential Job Functions:

- Conduct 21 CFR Part 11 gap assessments for plant and laboratory equipment.

- Review computerized systems associated with equipment, including PLC, SCADA, DCS, HMI, Client, EMS, MES, LIMS, and standalone systems.

- Assess electronic records, electronic signatures, audit trails, user access, security, backup, recovery, data retention, and system controls.

- Evaluate equipment qualification and validation documentation, including URS, risk assessments, IQ/OQ/PQ, functional specifications, and validation reports.

- Review equipment configuration, system architecture, interfaces, and critical data flows.

- Identify compliance gaps and prepare risk-based remediation plans.

- Develop assessment protocols, checklists, gap reports, and CAPA recommendations.

- Conduct interviews with Engineering, Production, Quality, IT, and Validation teams.

- Support remediation activities and provide guidance on corrective actions.

- Ensure alignment with 21 CFR Part 11, EU Annex 11, GAMP 5, GMP, and data integrity principles such as ALCOA+.

- Present findings and recommendations to site and project stakeholders.

- Review system lifecycle documentation and assess compliance throughout the validation lifecycle.

- Assess controls for data creation, modification, review, approval, and archival.

- Evaluate system access controls, user roles, privileges, and segregation of duties.

- Review audit trail functionality and controls for critical GMP data.

- Assess backup, restore, disaster recovery, and business continuity controls for computerized systems.

- Review system interfaces and data transfers to identify potential data integrity risks.

- Assess legacy computerized systems and identify technical, procedural, and documentation gaps.

- Support development of risk-based strategies for remediation of identified compliance gaps.

- Provide technical and compliance guidance to engineering, validation, quality, IT, and project teams.

Qualifications:





Required Skills and Experience

- 12–16 years of experience in pharmaceutical manufacturing, computerized system validation, equipment validation, or GMP compliance.

- Strong hands-on experience with plant equipment and computerized manufacturing systems.

- Experience conducting 21 CFR Part 11, Annex 11, CSV, and data integrity assessments.

- Practical knowledge of equipment qualification and validation lifecycle activities.

- Experience with PLC/SCADA/DCS/HMI-based systems, laboratory instruments, and utility systems.

- Knowledge of audit trail review, electronic records, electronic signatures, user access management, and cybersecurity controls.

- Ability to assess legacy systems and identify technical and procedural gaps.

- Strong understanding of risk assessment methodologies and GMP documentation practices.

- Experience preparing detailed gap assessment reports, CAPA plans, and remediation roadmaps.

- Familiarity with pharmaceutical manufacturing processes, utilities, and critical systems.

- Strong communication, stakeholder management, and report-writing skills.

- Ability to work effectively with cross-functional teams across Engineering, Quality, IT, Production, and Validation.

- Strong analytical skills with the ability to translate technical findings into compliance risks and actionable recommendations.

Preferred Qualifications

- Bachelor’s or Master’s degree in Engineering, Pharmacy, Life Sciences, Information Technology, or a related field.

- Certification or training in CSV, GAMP 5, 21 CFR Part 11, EU Annex 11, or Data Integrity.

- Experience with regulatory inspections, audit readiness, and remediation projects.

- Prior experience working at large pharmaceutical manufacturing sites.





- Experience supporting computerized system and equipment remediation programs.

- Exposure to regulatory expectations related to GMP computerized systems and data integrity.

Key Deliverables

- Equipment and computerized system inventory.

- 21 CFR Part 11 gap assessment protocols and completed assessments.

- Risk-based gap assessment report.

- Data integrity and compliance risk register.

- CAPA and remediation plan.

- Management presentation and final assessment summary.

- System-wise gap assessment documentation and supporting evidence.

- Risk-based remediation roadmap for identified compliance gaps.

- Final recommendations and assessment closure documentation.

How to Apply: Interested candidates are encouraged to respond/submit their updated resumes, and for additional job opportunities, please visit Jobs In India – VARITE.

Unlock Rewards: Refer Candidates and Earn.

If you're not available or interested in this opportunity, please pass this along to anyone in your network who might be a good fit and interested in our open positions. VARITE offers a Candidate Referral program, where you'll receive a one-time referral bonus based on the following scale if the preferred candidate completes a three-month assignment with VARITE.

Experience Level Bonus Referral:

0-2 years

INR 5,000

2-6 years

INR 7,500

6+ years

INR 10,000

About VARITE: VARITE is a global staffing and IT consulting company providing technical consulting and team augmentation services to Fortune 500 Companies in USA, UK, CANADA and INDIA. VARITE is currently a primary and direct vendor to the leading corporations in the verticals of Networking, Cloud Infrastructure, Hardware and Software, Digital Marketing and Media Solutions, Clinical Diagnostics, Utilities, Gaming and Entertainment, and Financial Services.

Equal Prospect Employer:

VARITE is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, marital status, veteran status, or disability status

📌 Senior Consultant – Equipment 21 CFR Part 11 Gap A (Bengaluru)
🏢 VARITE
📍 Bengaluru