Specialist, Compliance
2 weeks ago
A career at Resilience is more than just a job - it’s an opportunity to change the future.
Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
For more information, please visit
JOB SUMMARY:
The focus of this role is to support the manufacturing team with achieving and maintaining a high level of GMP compliance within the Company to meet client, regulatory agency, and RESILIENCE expectations.
MAJOR RESPONSIBILITIES:
- Coordinate Compliance Wire training activity (SOP & technical) within Manufacturing including delivery of Compliance related training.
- Review of executed Batch Production Records (BPR) and ensure timely turnaround to Quality department and client.
- Assist with investigations (Deviations, Out-of-Specification, and Environmental Monitoring Excursions), and ensure timely closure.
- GMP document control which includes but not limited to creation/revision/closure of CAPAs, SOPs, logbooks, MCCPs.
- Generate Effectiveness Checks as result of CAPA execution and ensure timely closure.
- Initiate Change Controls related to documents and equipment for manufacturing, ensure execution and timely closure.
- Assist with completing CAPA actions and ensure timely closure of CAPA records for the Manufacturing Department.
- Assist with addressing audit observations (internal, client, regulatory) and ensure timely closure.
- Conduct regular inspections during GMP batches to assess GMP and GDP compliance, and report any issues identified to management.
- Responsible for compliance logbook reviews.
- Provide proactive leadership in moving quality & compliance goals forward within the department.
- Maintain departmental KPIs to monitor trends for process improvement.
- Ensure timelines for batch start are achieved by timely request of documents required for the batch.
- Work closely with department staff to assist them in implementing effective risk based GMP processes, procedures and documentation.
- Perform all other job-related duties as assigned.
This position is a fixed-term contract position for the next 18 months.
PREFERRED QUALIFICATIONS / EXPERIENCE:
- University degree or equivalent in science
- 1-3 years of pharmaceutical experience in manufacturing, quality, or compliance
- Knowledge of GMP guidelines, Health Canada, FDA, EMEA
- Previous experience in a Quality function
BEHAVIOURAL:
Standards: Strong desire to achieve and maintain required standards
Decision Making: Utilizing effective process to make decisions
Teamwork: Working effectively and productively with others
Interpersonal Skills: Effectively communicating, building rapport, and relating well to all personality types
Organization and Planning: Utilizing logical, systematic and orderly procedures to meet objectives
Goal Orientation: Energetically focusing efforts on meeting a goal, mission or objective
- This job profile provides an overview of the minimum requirements of the job and does not include all of the duties inherent, included or associated with the job or with the performance of the job. The Company reserves the right to make changes to the job profile as it sees fit to meet the needs of the organization._
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).
Resilience Biotechnologies Inc. (RESILIENCE), 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.
Resilience Biotechnologies Inc. (RESILIENCE), 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.
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