This role is accountable to assure compliance, implement, develop and provide training, evaluate and implement software enhancements, and collaborate closely with IT for all cGMP Quality IT Systems. Provides project management, guidance and oversight for the evaluation and implementation of Quality based IT systems. The main responsibilities for this position are listed below.
WHAT YOU WILL BE RESPONSIBLE FOR / PRIMARY ACTIVITIES:
- Design, configuration, implement, enhance, validate, and support (SME) Trackwise instance and workflows to meet compliance and business needs
- Design, configuration, implement, enhance, validate and support all Quality based IT systems with IT and department owners to meet compliance and business needs
- Ensure 21 CFR Part 11 requirements are evaluated for all GMP systems
- Evaluate and remediate legacy IT systems with departmental owners and IT
- Stay current to Data Integrity Health Authority requirements and assure systems and data meet requirements
- Develop and conduct periodic Data Integrity training to all staff
- Design, develop, validate and implement Quality Metrics tools for data analysis, trending and reporting for Quality Council
- Design, develop and prepare reports for management and staff as requested
- Provide training on Trackwise and or other Quality systems as required to new employees
- Liaise with external support system suppliers to resolve technical issues
- Work with internal stake owners to improve existing work flows
- Prepare and support validation requirements and departmental owners during preparation of URS, protocols, test scripts and execution of validation activities for Trackwise and other Quality IT systems
- Prepare, conduct, review and approve executed test scripts during validation activities
- Review and update applicable SOP & Manuals for implementation and use
- Co-ordinate and work with New Software Vendors, IT (Infotech Department), Validation and department owners for new Quality software implementation
- Management responsibility to supervise team, develop staff and meet business objectives
- Develop, justify and obtain approval to meet annual budget and capital plan
- Act as back-up for staff as required
- Perform additional duties as required.
OUR MINIMUM REQUIREMENTS:
- University degree or equivalent with computer science.
- Trackwise user and configuration experience for minimum 3 years.
- Design, develop and implement Quality IT systems
- Working understanding of GMP guidelines for Health Canada, FDA and MHRA for computer systems and compliance.
- Proficiency in developing and maintaining Quality Systems including Access databases.
- Proficiency in working with Trackwise (Sparta training is an asset), QC lab systems (LIMS), statistical packages, MS Excel, Word and PowerPoint
- Health Authority Data Integrity Global requirements
While we appreciate your interest in this opportunity, only qualified candidates will be contacted.
Therapure Biopharma Inc. will not be responsible for any agency referral fees arising from the use of resumes that currently exist in the recruitment database or have been forwarded to Therapure Biopharma directly or indirectly without an authorized agreement. Agency referrals will not be accepted unless approved by the Therapure Biopharma Inc. Human Resources team.
NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including pre-employment medical (where applicable), educational, employment, references, and criminal records checks (for which a pardon has not been granted).
Therapure is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process. Applicants are asked to make their needs/requirements known to Human Resources.Apply Now