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.
Responsibilities:
- 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.
- Logging, analysis and review of customer complaints received. Participate 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. SOP’s WISOP’s, Quality Policy and other compliance related documents).
- Coordinate the preparation and submission of Quality Defect Reports as required and support any recalls as necessary and manage mock recalls.
- Participate in the preparation of and delivery of routine and annual GMP training on site.
- Oversight and management of Quality agreements and review of ECOs are required.
- Support continuous improvement on site and corporate projects as required.
- Lead and participate in Quality Risk Management exercises, as required.
Requirements:
- 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.
