Computer System Validation - C & Q
PharmEng Technology
Canada
6d ago

Job Description :

  • Develop and execute documentation for validation and qualification activities to support various computer system validation projects.
  • Documents to be authored may include : Project Validation Plan, Requirements Trace Matrix, Risk Assessment, IQ / OQ / PQ, Validation Summary Report, Data Transfer and Integrity Testing Protocol, Change control, SOPs, etc.

  • Support development of validation deliverables, such as Functional Requirements Specification (FRS), Detailed Design Specification, etc
  • Solve problems during validation process and address / advise on issues such as deficiencies, deviations and change control, etc.
  • Ensure compliance of computerized systems to relevant regulatory requirements (e.g. cGMP / GLP / GAMP / GALP).
  • Complete assigned projects and tasks within agreed deadlines.
  • Review existing SOPs and prepare draft to serve as the framework for Computer System Validation Projects
  • Draft templates for High level Risk Assessments, User Requirements Specification, Validation Plan and Validation Summary Reports
  • Prepare validation documentation packages and complete validation of Computerized Laboratory Systems
  • Acts as liaison between Quality Assurance and project team to assure that GxP software is implemented in compliance with applicable regulations and guidelines.
  • Assist in the development of a validation remediation strategy, as required
  • Improve data quality of the system, harmonizing when necessary through the development and implementation of change controls (patches), or implementing a process to improve the quality of the information.
  • Ensure accuracy and timeliness of manual migration data updates
  • Job Requirements :

  • Support the generation and execution of all commissioning and qualification documentation related to demonstration batches, thermal studies, validation studies for equipment, facilities, utilities, engineering test runs, development studies, software validation and final reports.
  • Ideal candidate would have worked in GMP Lab environment and done CSV for lab instruments
  • Scientific background (Chemistry, Biology), or IT background (with specialty / experience in Lab systems)
  • Agilent systems (HPLCs, LCMS, GCs)
  • Waters systems (HPLC, LCMS)
  • Plate Readers (Softmax Pro), Plate washers,
  • Spectrophotometers (Beckman, Agilent)
  • DNA Sequencers (Sciex, Roche)
  • Review site commissioning and qualification documentation for accuracy, technical soundness and compliance to both site and regulatory guidelines.
  • Projects may include new facilities / equipment startup, commissioning, FAT, manufacturing equipment qualification, laboratory equipment qualification and computerized and automation systems including FMS and BMS systems.
  • Provide support for the development of user requirement and functional specifications.
  • Review technical and quality system documents such as SOPs, Change Control and Deviation Reports, Batch Production Records, Technical Manuals, P&IDs, construction, as-
  • built, flow diagrams as they relate to validation principles and regulatory compliance issues.

  • Review various documentation and drawings to ensure any document changes, meet quality and validation requirements and are in full compliance with regulations and standards.
  • Provide technical assistance during investigations of process / equipment / cleaning / validation issues and aid in the resolution of validation deviations, protocol discrepancies and non-conformances.
  • Support, investigate and troubleshoot problems and determine possible solutions.
  • Provide effective solutions for the management of system deviations and non-conformances
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