We are delighted to be representing a well-established pharmaceutical company based in Wicklow, on a permanent QA Compliance Specialist opening.
Reporting to the QA Compliance Manager and working as part of the QA Compliance team, the successful candidate will be expected to carry out the role and responsibilities of the job function in an autonomous and responsible manner to meet all related targets and deadlines while maintaining good relations with, and flexibility within your team and other departments.
As QA Compliance Specialist you will:
* Ensure the effective implementation of the Pharmaceutical Quality System, ensuring the organisation remains in compliance with the most up-to-date regulatory and licensing requirements in accordance with corporate and regulatory guidelines.
* Log, analyze and review customer complaints received, participating in root cause(s) review and decision on preventative actions, and provide a timely response to customers.
* Draft, review and approve written procedures and other documents including amendments to those documents (e.g. SOPs, WISOPs, Quality Policy and other compliance-related documents).
* Coordinate the preparation and submission of Quality Defect Reports as required, support any recalls as necessary, and manage mock recalls.
* Participate in the preparation and delivery of routine and annual GMP training on site.
* Oversee and manage Quality agreements and review of ECOs as required.
* Support continuous improvement on site and corporate projects as required.
* Lead and participate in Quality Risk Management exercises, as required.
Education & Experience Required
* 4 years’ experience in the Pharmaceutical Industry and a 3rd level qualification in a scientific discipline.
* Strong communication skills and interpersonal skills.
This is a hybrid working arrangement which would see you attend the site 3 days per week.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance, Science, and Manufacturing
Industries
Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Hospitals and Health Care
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