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Computer System Validation Specialist - 18 Month Contract in Oakville at Innomar Strategies

Date Posted: 12/3/2018

Job Snapshot

Job Description

Under the general direction of the Manager, QA Software Testing & Validation, the Computer System Validation (CSV) Specialist is responsible for the implementation of Innomar’s CSV strategy and leading all validation efforts on computerized systems (hardware & software) to support business systems that have GxP impact, ensuring compliance with PIC/S Annex 11 and 21CFR11 requirements is established and maintained at all times. This includes prioritizing, executing, maintaining, and coordination of CSV activities, evaluation of software applications against design specifications and user requirements, and serves as the liaison between the appropriate IT, operational business units and external partners (where applicable) on validation activities, in order to ensure project expectations are properly set and met as per company policies and procedures. The CSV Specialist may occasionally support software/application testing.

What You'll Do:

Job Requirements

Requires a minimum of three (3) years hands-on experience in validation of GxP computerized systems and software development methodologies, preferably in the pharmaceutical, biotech or medical device environment with extensive experience in a matrixed environment and interactions with external vendors. A college or university degree in computer sciences (e.g. IT, information security, engineering, software programming, etc.) is required.

  • Requires formal training in the field of computer sciences (e.g. IT, information security, engineering, software programming, etc.), business administration or similar vocations generally obtained through completion of a four year Bachelor’s Degree program, technical vocational training, or equivalent combination of experience and education.
  • Requires a thorough knowledge and understanding of computer system validation processes and regulatory requirements, including ISPE GAMP5, 21 CFR part 11, Annex 11and other harmonized international guidelines (PIC/S, ICH) and GxP.
  • Ability to communicate effectively both orally and in writing is a must.
  • Demonstrated understanding of quality assurance and quality systems principles (training documentation, change control, validation, vendor management and audits).
  • Hands-on experience in validation of GxP systems is required.
  • Experience in auditing of IT and validated systems are required.
  • Excellent teamwork and interpersonal skills; leadership and relationship building skills.
  • Strong analytical, problem-solving and conceptual skills.
  • Excellent organizational skills; attention to detail.
  • Ability to resolve system issues effectively and efficiently.
  • Ability to prioritize work load and consistently meet deadlines
  • Practical understanding of project management principles and methodologies.
  • Experience in creation and review of Standard Operating Procedures (SOP’s) is desirable.
  • Experience in using automated enterprise testing tools is an asset in order to support and assist company’s testing initiatives.
  • Experience with one of the following testing tools is an asset: Quality Center, LOADRUNNER, or QUICKTEST PRO.
  • Working knowledge of relevant technology, tools and software; knowledge of UNIX, SDLC, Desktop services, HP Test tools, or equivalent testing tools.