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Senior Consultant at Mason Alexander - Medtech Contract
We are representing a well-established pharmaceutical company based in Wicklow, offering a permanent QA Compliance Specialist position.
Reporting to the QA Compliance Manager and working within the QA Compliance team, the successful candidate will perform their duties autonomously, meeting targets and deadlines while maintaining good relations and flexibility within the team and other departments.
Responsibilities:
* Implement and maintain the Pharmaceutical Quality System to ensure compliance with regulatory and licensing requirements, following corporate and regulatory guidelines.
* Log, analyze, and review customer complaints; participate in root cause analysis and determine preventative actions; respond to customers promptly.
* Draft, review, and approve documents such as SOPs, WISOPs, Quality Policies, and other compliance-related documents.
* Coordinate the preparation and submission of Quality Defect Reports, support recalls, and manage mock recalls.
* Deliver routine and annual GMP training onsite.
* Manage Quality agreements and review ECOs.
* Support continuous improvement initiatives and corporate projects.
* Lead and participate in Quality Risk Management exercises.
Requirements:
* At least 4 years of experience in the Pharmaceutical Industry and a third-level qualification in a scientific discipline.
* Strong communication and interpersonal skills.
This role offers a hybrid working arrangement, requiring attendance on-site 3 days per week.
Additional Details
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Quality Assurance
* Industry: Pharmaceutical Manufacturing
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