Quality Assurance Associate, Computerized Quality Systems - Brampton, Ontario Canada - 18504

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JOB DESCRIPTION

Job #: 18504
Title: Quality Assurance Associate, Computerized Quality Systems
Job Location: Brampton, Ontario - Canada
Employment Type:
Salary: contact recruiter for details
Employer Will Recruit From: Local
Relocation Paid?: NO

WHY IS THIS A GREAT OPPORTUNITY?


Our client in Brampton is actively looking to fill in this full-time position. 

JOB DESCRIPTION

Duties and Responsibilities:

  • Ensuring that all automated and non-automated data systems are compliant to current regulatory expectations related to CFR Part 11, GAMP 5 and Data integrity requirements
  • Providing support to sites for the oversight of Data Governance Plans to ensure the maintenance of data integrity for all records, paper, hybrid and electronic, required under GMP throughout the data lifecycle
  • Providing Quality oversight activities related to design, installation, qualification, maintenance of global automated systems such as LIMS, TrackWise, SAP, etc.
  • Providing Quality oversight of critical data systems for all company locations and major business partners
  • Providing guidance and support to the site Data Governance Officers for the purpose of overseeing the Site Data Governance Plans
  • Performing internal audits of Site Systems to ensure alignment with the requirements of the company Site and Global SOP’s and Policies
  • Performing oversight of the assessment of all systems (paper, hybrid or computerized) of the site level delivered by the site Data Governance Officers and Business Data Stewards. The oversight should ensure that assessment was performed using a risk-based approach and commensurate with the risk of the system on data integrity throughout the data and product lifecycles
  • Reporting on new compliance regulations from Regulatory authorities related to Data Integrity and Data Governance
  • Acting as the official designate for the Director, Corporate Quality, IT and Computerized Quality Systems
  • Supporting the site Quality IT and computerized systems as needed. (*)
  • (*): Due to the temporary nature of the position and the project loads, the associate might be requested to support the site QA IT and Automated systems functions on an Ad Hoc basis. During these tasks, the reporting structure might change to the site Quality head.

 

QUALIFICATIONS

Requirements:

  • Minimum of B.Sc. Chemistry or other associated field

• At least 5 years at the supervisory/management experience is preferred
• Experience in pharmaceutical computerized systems

  • Experience in inspection from Regulatory agencies officials (Health Canada, USFDA, MOH, MHRA)

• Knowledge of cGMP, FDA, HPFBI and associated guidelines related to Data Integrity and Data Governance
• Enthusiastic and self-motivated
• Strong analytical and problem solving skills
• Ability to effectively analyze problems, exercise sound judgement and make timely decisions
• Ability to influence without authority
• Strong ability to extract information by questioning, active listening and interviewing to elicit and formally define requirements
• Demonstrated ability to work under pressure and manage conflicting priorities
• Excellent organizational skills and multi-tasking ability
• Excellent written and verbal communication
• Problems associated with a wide variety of data integrity/data governance challenges
• Problem solving associated with dealing with multiple departments simultaneously
• Experience in data integrity and data governance is preferred

Job Types: Full-time, Contract