To perform and document Computer System Validation as per defined processes at Corporate IT and across sites.

QUALIFICATION

- Graduate in Science/Pharmacy/Engineering
- Post Graduation Science/MBA (Desirable)

EXPERIENCE:
- Candidate with 6 10 years of experience in Pharma/Life science domain working on CSV, Part 11/Annex 11, Data Integrity
- Work experience in both IT Sector and Pharma Sector will be desirable

SKILLS AND COMPETENCIES
- To provide consultancy to CSV team for CSV and Regulatory Compliance activities
- To have functional knowledge of Regulatory guidelines, Quality and Manufacturing processes.
- Knowledge of IT systems and ITIL processes (e.g. Backup/Restoration, Infrastructure qualification,

User access Management, etc.)
- A team player with good communication skills (verbal written)
- Any other tasks as assigned by his/her reporting manager
- To have thorough understanding, practical approaches for Computer system validation (CSV) o enterprise level applications.
- Accountable to ensure compliance of CSV documentation during various phases (project,operational retirement) of software lifecycle (SLC).Well aware with GAMP5, CFR Part 11/E Annex 11 and Data integrity requirements.
- To create CSV deliverables for IT projects e.g. URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment etc.
- To create infrastructure ((Network, Servers, Cloud, Database) qualification documentation.
- To create QMS documents e.g. Change control / Deviation / Incidents-Discrepancy / User access forms.
- To perform Root cause analysis and define CAPA based on QMS documents review.




- To perform periodic and audit trail review of computerized systems as per defined frequency.
- To support the initiatives undertaken by Quality eCompliance and CSV team across the

Corporate/PEL sites.
- Perform IT Supplier assessment and ensure compliance of audit observations.
- To liaise with Site ITC SPOCs for CSV activities and IT Compliance initiatives.
- To guide and train IT CSV teams (Corporate Site) for CSV, Data Integrity and Regulatory

Compliance activities.
- Ability to represent during regulatory audits and can able to perform Corporate DI Audits of sites.
- To work along with CSV Project Manager to ensure project timelines are met.
- Experience on validation of any of the enterprise level applications. e.g. Trackwise,

Ensur/Documentum, LIMS, LMS, SAP, Chromatographic, Serialization, etc.
- Author, review and approval of SOPs, Guidelines/Policies as applicable.

SKILLS AND COMPETENCIES:-
- Good knowledge of 21 CFR Part 11 / Annexure 11 (Must)
- Good knowledge of CSV, GAMP 5 (Must)
- Positive knowledge of Data Integrity requirements for Pharma (Must)
- Experience of working at Pharma Site QC, QA, IT, CSV etc. (Plus)
- Experience of validation on automation/digitization projects (Plus)
- Good Verbal and Written communication skills (Must)
- Aware of industry best practices and knowledge about Pharma 4.0 (Plus)
- Functional knowledge of Regulatory guidelines, Quality Control and Manufacturing processes

(Plus)
- Knowledge of IT systems and ITIL processes (e.g. Backup/Restoration, Infrastructure qualification, User access Management, etc.) (Must)

📌 Manager It (Mumbai)
🏢 Augusta Infotech
📍 Mumbai