Compliance Specialist (Fixed Term Contract)

Resilience • Mississauga, ON

2d • CA$24 - CA$33 • Onsite

About The Position

The focus of this role is to support the manufacturing team with achieving and maintaining a high level of cGMP compliance within the Company to meet client, regulatory agency, and RESILIENCE expectations.

Requirements

• Knowledge of GMP guidelines, Health Canada, FDA, EMA
• Previous experience in a Quality function
• University degree or equivalent in science
• 1-3 years pharmaceutical experience in manufacturing, quality, or compliance
• Demonstrate ability to apply the following behavioural competencies on the job: Goal Orientation, Leadership, Problem Solving, Interpersonal Skills, Decision Making

Responsibilities

• 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 CCs, DCCs, CAPAs, SOPs, logbooks, MCCPs.
• Review 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 on the floor.
• Review and assess alarms for manufacturing areas as per procedure.
• Provide proactive leadership in quality & compliance goals forward within the department to assist in maintaining 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.

Benefits

• annual cash bonus program
• RRSP/DPSP with a generous company match
• competitive healthcare, dentalcare, vision care, life, LTD, and AD&D benefits package
• fertility healthcare and family-forming benefits
• paid vacation
• paid holidays
• pregnancy and parental leave top-up plan
• tuition reimbursement
• employee referral program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree