JOB OVERVIEW: 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) of
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/EU
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)
Required Skills and Experience
Industry:
Bio-Technology&Life
Role:
MANAGER IT CSV
key Skills :
CSV, Computer System Validations, Gxp, Pharma, Medical,
Education :
B.Pharm,B.Sc
Email ID:
[email protected]
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