OVERALL JOB RESPONSIBILITIES

1. To oversee and support in implementation, validation and management of GxP computerized systems (e.g. Manufacturing, Laboratory) used at site throughout the lifecycle by providing a sound understanding of validation, qualification, testing requirements and periodic reviews.

2. To have Quality oversight on GxP computerized systems, Computer System Validation (CSV), Data Backup/Restore, IT documentation and QMS and ensuring compliance with regulatory standards, IT policies and procedures through periodic audits / quality reviews.

3. Review of CSV lifecycle documents, ensuring they incorporate all regulatory requirements and in line with site procedures.

4. Collaborate with project managers to identify potential risks and develop mitigation strategies during project lifecycles.

5. Conducting assessments of GxP Computerised System projects during implementation and maintenance.

6. Support internal and external audits by providing necessary documentation, evidence of compliance, and explaining CSV and IT compliance related processes.

7. Assessment of supplier and service providers w.r.t regulatory and business requirements.

8. Support in routine audits of GxP computerized systems, processes, and documentation to identify gaps and areas for improvement.

9. Support in periodic reviews and audit trails review of GxP computerized systems per relevant procedures.

10. Collaborate with Supplier, QA and IT teams to address audit findings and implement corrective and preventive actions (CAPAs).

11. Review of standard operating procedures (SOPs) and follow periodic training and evaluation plan for the team members.

12.



To impart training to internal and external stakeholders on cGMP topics, IT-Quality and SOPs.

13. Initiate, Review, Assessment and timely closure of QMS events related to GxP computerized systems.

14. Collaborate with cross-functional teams to ensure quality standards for GxP computerized systems and Data Integrity.

15. Proactive risk / impact assessment prior to implementation of any change to ensure effective implementation.

Preferred candidate profile

- Experience: 6- 10 years of relevant experience in IT Quality Assurance (ITQA), Computer System Validation (CSV), or IT Compliance.

- Qualification: B.Pharm, M.Pharm, B.Tech, or M.Sc. in a relevant discipline. (Computer Science, Information Technology, Biotechnology, Life Sciences, Pharmacy, or related disciplines).

- Strong knowledge of Computer System Validation (CSV), GxP, GMP, GAMP 5, 21 CFR Part 11, EU Annex 11, Data Integrity (ALCOA+), QMS, CAPA, Change Control, and Risk Assessment.

- Experience in validation and compliance of GxP computerized systems such as LIMS, MES, ERP/SAP, Manufacturing, or Laboratory systems.

- Exposure to regulatory audits (FDA, MHRA, EU GMP, WHO GMP) and review of validation lifecycle documentation.

- Good understanding of IT quality processes, documentation, SOPs, and supplier/vendor assessments.

- Solid analytical, communication, stakeholder management, and cross-functional collaboration skills.

- Candidates from the pharmaceutical industry are preferred; however, candidates with relevant IT Quality/CSV experience from other regulated industries are also encouraged to apply.

- Must be willing to relocate to Goa.

📌 Manager - IT Quality Assurance (ITQA) (Goa)
🏢 Glenmark Pharmaceuticals
📍 Goa