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Compliance Operations Manager
2 months ago
The Regulatory Compliance Specialist will play a critical role in ensuring the manufacturing team at Resilience meets and maintains high levels of compliance with regulatory agencies, clients, and company expectations. This includes reviewing executed Batch Production Records (BPR) and ensuring timely turnaround to the Quality department and clients. The successful candidate will also assist with investigations (Deviations, Out-of-Specification, and Environmental Monitoring Excursions), and ensure timely closure.
Key Responsibilities- Coordinate Compliance Wire training activities within Manufacturing, including delivery of Compliance-related training.
- Manage GMP document control, including creation, revision, and closure of CAPAs, SOPs, logbooks, and MCCPs.
- Generate Effectiveness Checks as a 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 and compliance goals forward within the department. Maintain departmental KPs 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.
- University degree or equivalent in science.
- 1-3 years of pharmaceutical experience in manufacturing, quality, or compliance.
- Knowledge of cGMP guidelines, Health Canada, FDA, EMEA.
- Previous experience in a Quality function.
The successful candidate will demonstrate the ability to apply the following behavioral competencies on the job:
- Goal Orientation: Energetically focusing efforts on meeting a goal, mission, or objective.
- Leadership: Achieving extraordinary business results through people.
- Problem Solving: Anticipating, analyzing, diagnosing, and resolving problems.
- Interpersonal Skills: Effectively communicating, building rapport, and relating well to all personality types.
- Decision Making: Utilizing effective processes to make decisions.
