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Manager Validation System

Ontario, ON
PharmEng Technology is currently seeking a Manager Validation System  a project in Ontario, Canada The position is available immediately conditional of a successful interview
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Job Description:
  • Manage and lead GxP computerized systems periodic review program by:
  • Establishing site system periodic review plan with periodic review schedule by following the relevant governance SOPs on system periodic review. The plan will cover GxP computerized systems utilized for manufacturing shop floors, QC Laboratories, and systems supported and maintained by information Technology & Solutions.  
  • Communicate and coordinate with system and process owners, system supporting functions to ensure that system periodic review plan is reviewed, approved and ready for execution.
  • Coordinate the execution of the periodic review plan to ensure that the periodic review schedule is completed as expected
  • Develop the periodic review report to provide evidence that an effective review has taken place, with necessary corrective actions and plans in place as needed
  • Coordinate and follow up on closure of corrective actions and plans as needed.
  • Develop the periodic review report to provide evidence that an effective review has taken place, with necessary corrective actions and plans in place as needed.
  • Coordinate and follow up on closure of corrective actions and plans as needed.
  • Manage and lead electronic data periodic review (EDPR) program by: Developing annual site electronic data periodic review plan with review schedule per relevant governance procedures;
  • Communicate and coordinate with system and process owners to ensure that the EDPR plan is reviewed, approved and ready for execution.
  • Coordinate the execution of the EDPR plan to ensure that the review schedule is completed as expected.
  • Support in determining corrective actions resulted from EDPR process. Follow-up.
  • Develop the EDPR report to provide evidence that an effective review has taken place, with necessary corrective actions and plans as needed.
  • Coordinate and follow up on closure of corrective actions and plans as needed.
  • Update and maintain site computerized system inventory list and ensure it is current, accurate and complete to reflect the system status.
  • Participate and provide audit and inspection support and coordination for system validation related requests.
 
Job Requirements:
  • A degree in Engineering or Science combined with 5 to 7 years of relevant working experience within the biopharmaceutical industry.
  • Good interpersonal and influencing skills are important for a candidate's success in this role.
  • Working knowledge and hands-on experience with computer and application skills, scientific writing, supervision I management of teams and people (and their development), effective oral and written communication skills, and innovative thinking.
  • Ability to anticipate evolutions due to internal and external factors.
  • Ability to challenge status quo.
  • Conflict resolution and problem solving.
  • Familiarity with strategic pianning, balanced judgment and risk analysis.
  • Planning and organizational skills.

Thank you for your consideration and application!  We review all resumes and submissions, however, due to the sheer volume of requests that we receive, only successful candidates will be contacted
 
 
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