Information Technology - Officer (Goa)

Role & responsibilities
- Perform end-to-end CSV activities for GxP systems.
- Prepare and review URS, FS, RA, IQ, OQ, and PQ documents.
- Ensure compliance with GxP, 21 CFR Part 11, Annex 11, and Data Integrity requirements.
- Support audit trail review, deviation investigation, and CAPA activities.
- Manage validation lifecycle for MES, LIMS, ERP, QMS, and other applications.
- Participate in change control, impact assessment, system implementation, and upgrades.
- Support regulatory audits including USFDA, MHRA, and WHO inspections.
- Maintain RTM and validation documentation as per SOPs and QMS.
- Follow risk-based validation approach aligned with GAMP 5 guidelines.
- Coordinate with QA, IT, Production, and vendors for validation activities and system integration. Required Qualifications
- Bachelors degree in engineering / pharmacy / computer science / IT
- 3-7 years of experience in CSV in pharmaceutical or regulated industry
- Strong knowledge of:
- GAMP 5 guidelines
- 21 CFR Part 11
- EU Annex 11
- Data Integrity (ALCOA+) Key Competencies
- Solid documentation and technical writing skills
- Experience with validation tools and templates
- Knowledge of SDLC and validation lifecycle
- Good analytical and problem-solving skills
- Familiarity with audit processes Key Deliverables
- Experience with MES, LIMS, SAP, or QMS
- Exposure to automation systems and PLC integration
- Understanding of cybersecurity in GxP systems Interested candidate can share their resume on the below email Id- or WhatsApp their resume 7021725348. Apply on Kit Job: kitjob.in/job/4mssc1