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Posted on:25-Aug-2022

MANAGER IT CSV

Location: Mumbai
Experience: 6 - 10 Yrs
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Job Description

Hiring, Manager IT CSV

 

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:

Resume.Augusta@augustainfotech.com