At Therapure Biopharma Inc., we’re specialists in biologics. In our three divisions; Therapure Biomanufacturing, Therapure Innovations, and Evolve Biologics, our passion for quality and patient safety underpins everything we do. Therapure Biomanufacturing is a global contract development and manufacturing organization (CDMO); Therapure Innovations is devoted to drug discovery, and research and development. Our scientists are currently developing innovative protein therapeutics in anemia, liver cancer, and hepatitis C; and Evolve Biologics is developing treatments for people with rare diseases who lack important proteins in their blood. Our core technology has the potential to be the first major advancement in plasma protein extraction in over 75 years.
The department management will assign the specific systems/activities to the role as primary responsibilities and for providing secondary and/or back-up support to other systems/activities as required.
The Quality Compliance departmental systems and related activities include Document Management, Change Control, Product Recall and Regulatory Notifications, Internal Audits, Supplier Qualification activities, Training Management, Annual Product Quality Review, Product Complaint, and Regulatory Licenses Registrations. Provide required support to Client Audits and Regulatory Inspections.
- Document Management System
- Maintain compliance to Document Management procedures.
- Develop, control, and maintain the documentation necessary to ensure compliance to regulatory requirements and internal quality procedures.
- Author (i.e. technical writing) key document control procedures relating to GMP requirements (Examples include Standard operating procedure and Work Instructions Procedure, document control and archival, etc.).
- Ensure format for SOPs/WINs/ DOCs/ Forms/ APP are in compliance with procedural requirements including those for Macro in Fillable Forms.
- Maintain working Word copies and final Word copies of all types of master documents.
- Maintain protocol registry database.
- Complete all requests of controlled documentation issuance including those required to support Quality Systems and the clients.
- File and control of current, superseded, and obsolete Master documents (e.g. Specifications, Manufacturing Batch Records, SOPs, WINs, QCPs, QC Protocols, QC Test Summary and Report and AMRTRs).
- Owner of Document Control Storage Room and administer general control security access.
- Support regulatory inspections and client audits.
- Maintain SOP Database Current for procedure approval and periodic review.
- Lead improvement program in Document Management, Archival and Retrieval
- Administrator for all Quality Compliance supplies requirements.
- Perform archiving of required change controls periodically.
Change Control System:
- Maintain change control system in compliance as per established procedure.
- Lead the Change Control Committee for change control endorsements.
- Review and assess change controls for post-approval for closure and determine the requirements of change control effectiveness check plans.
- Maintain change control database and perform trending for improvements.
- Maintain change control in/out logbook to ensure all change controls are accounted for.
- Perform archiving of required change controls periodically.
- Provide change control updates to the client as required.
- Product Complaint, Product Recall and Regulatory Notifications
- Support Quality Management on product complaint and product recall events as per established procedures.
- Prepare a risk-based annual internal audit schedule.
- Perform internal audits of areas identified in the approved internal audit schedule and assess their compliance with internal policies/procedures.
- Document audit findings in a detailed written report, assign risk classification (critical, minor or major) for all findings, and provide compliance assessment for the area/system/process audited.
- Timely approval of audit report, compile audit finding responses, review and approve the audit report.
- Maintain audit files and findings database for tracking to closure purposes.
- Review, approve and close internal audit related CAPAs to ensure that the completed actions appropriately address findings.
- Review and approve departmental Self-Inspection reports.
- Maintain departmental Self-Inspection reports database and files.
- Trend Internal Audit findings to demonstrate that corrective action implemented are effective.
- Perform other internal system compliance assessment/audit as required.
- Provide regulatory assessment support.
- Work independently or collaboratively with all departments to ensure internal audits related activities are completed within the required timelines.
Supplier Qualification System
- Support Supervisor, Quality Compliance to
- Review and approve new material requests with a verification of the material risk category.
- Initiate a supplier qualification process as per the material/service risk category.
- Review quality agreement and coordinate the approvals at Therapure.
- Approve material / service provider upon completion of supplier qualification requirement.
- Maintain material change notification process.
- Maintain material complaint process
- Perform new hire GMP Training.
- Responsible for coordinating and ensuring the completion of Annual GMP and GDP training company wide.
- Coordinate all activities training program in ComplianceWire.
- Maintain Training records where applicable.
- Ensure existing roles training curricula are current with department manager.
- Assist and organize other necessary trainings as requested by department managers.
- Coordinate Quality Council and Metrics activities for Quality Management.
- Prepare monthly Training Metrics.
- Responsible for maintaining training and ComplianceWire procedures current.
- Collaborate with department managers to develop and prepare the training curricula for new roles.
Annual Product Quality Review (APQR)
- Prepare annual schedule of APQR and obtain management approval.
- Follow APQR procedure to organize, compile and complete APQR report as per the client Quality Agreement requirements for all commercial products.
- Collaborate with departments to ensure that product-specific APQR requirements are understood and required information is obtained.
Regulatory Inspections and Client Audits
- Support regulatory inspections and client audits as assigned by Quality Management.
- Perform required regulatory licenses registrations for Therapure, as outlined in applicable regulatory guidance, assigned by Quality Management.
- Provide proactive role in moving quality compliance goals forward throughout the organization and achieving positive and value-added results.
- Performs additional duties as assigned by Quality Management and as required to support business requirements.
TECHNICAL KNOWLEDGE / EXPERIENCE:
- University degree in Science
- 3-5 years of experience in pharmaceutical or biologics industry.
- For Supplier Qualification System: Previous experience in auditing, supplier management, quality systems, and certification in auditing.
- For Internal Audits: Previous experience in auditing, auditing principles, and certification in auditing.
- For Document Management: Advanced knowledge of Microsoft Word, Excel, PowerPoint, Adobe Acrobat, and programming Macro.
- Quality Assurance experience in various Quality Systems.
- Track record of compliance achievements.
- Required knowledge of cGMPs guidelines, Health Canada, FDA, EMEA requirements.
- Regulatory experience for license registrations.
- Pre-employment medical and medical re-examination performed every 2 years will be required as per Therapure’s SOPs
- This position requires vaccination for Hepatitis A and B
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 ResourcesApply Now