Manager It

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)
• Good 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)