MES Specialist

IE  ‐ Onsite
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Description

Duties:
  • Generation, execution, review and approval of IOPQ protocols and associated validation documents and CSV assessments eg Part11 Assessments, etc. related to MES systems and related IT Applications and Infrastructure.
  • Prepares/reviews validation documentation related to projects/change controls.
  • Manages change controls and other compliance related tasks eg non-conformances.
  • Participates in the review of current and future CSV procedures and polices.
  • Analyses the results of testing and determines the acceptability of results against predetermined criteria.
  • Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
  • Identifies current and anticipated requirements for compliant computerised operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
  • Coordinates with other departments or outside contractors/vendors to complete validation tasks.
  • Participates in regulatory audits and communicates company's computer validation policies.
  • Assesses company's computer systems and identifies any potential Part 11 or Annex 11 gaps.
  • Manages projects and prepares status reports using Microsoft project and other communication tools.
  • May supervise, lead, or manage lower-level personnel.
Requirements:
  • Experience in a GMP environment essential.
  • Experience within the fields of Automation and Computer systems and IT Infrastructure Qualification/validation.
  • Biologics experience highly desirable.
Start date
ASAP
Duration
12 months
From
Quanta Consultancy Services
Published at
13.05.2017
Project ID:
1343215
Contract type
Freelance
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