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10-15 Years
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  • Posted a month ago
  • Over 50 applicants have applied

Job Description

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)

About Company

Augusta Infotech is a leading Executive Search and Recruitment Service provider for IT/ITES, Product Engineering, Manufacturing, Research and Development. We have been part of talent acquisition teams with several corporate giants for the past two decades as an internal customer and as a service provider.
Expertise in providing the best talents for Technology, Leadership, Management positions are our core forte. Specialized head hunting techniques and our knowledge base on resources ensures clients get the desired talent. We believe that relationships make a difference to the end result, so we take the time to get to know our clients businesses. Our thrust is on quality and time commitment to provide the needs of our clients.

Job ID: 113297119

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