Description
Description:
The Production QA Compliance Officer will proactively lead and manage the day-to-day Quality Assurance activities within Chanelle Pharma's designated Production areas (Realoch). The role will be responsible to deliver on all aspects related to quality compliance and execute tasks such as the creation and execution of quality documents to include change control, deviations, CAPA, FMEA whilst ensuring compliance to the Quality Management System.
Location:
Onsite in Loughrea, Co. Galway.
As our Production QA Compliance Officer, you will be responsible for:
* Ensure timely preparation, review, and approval of all quality reports within departmental deadlines.
* Lead, create, and review process investigations and risk assessment documents, ensuring thorough documentation and implementation of appropriate corrective actions.
* Initiate, investigate, and manage compliance documentation including Change Controls, Deviations, SCARs, Reject Notices, and CAPAs.
* Conduct routine quality audits within the department to verify compliance and proactively address any emerging issues.
* Develop and update Quality Procedures, including Standard Operating Procedures (SOPs), in alignment with current GMP regulations.
* Drive continuous improvement initiatives to enhance the company's Quality and GMP standards, with a focus on strengthening the overall quality system.
* Support and, when required, lead quality-related projects within the department, collaborating effectively with multidisciplinary teams.
* Participate in self-inspections, internal audits, and regulatory inspections, ensuring timely implementation of corrective actions.
* Contribute to Change Control meetings and actively participate in monthly Quality Management & Review meetings.
* Perform any additional duties as assigned by the responsible Production Manager.
Education & Experience:
* Bachelor's degree in a quality or science-related discipline.
* Lean/Six Sigma certification and statistical analysis knowledge are highly desirable and considered advantageous.
* Minimum of 4–5 years' experience in a GMP-regulated manufacturing environment, with a strong working knowledge of EU GMP and US FDA guidelines.
* Prior experience in the pharmaceutical industry is preferred; however, relevant experience in the medical device sector will also be considered.
* Strong report writing skills and proficiency in IT systems.
* Proven hands-on experience in delivering a best-in-class Quality Assurance function in a similar role.
Skills & Competencies:
* Excellent communication and interpersonal skills, with the ability to engage effectively across all levels.
* Strong analytical, methodical, and structured approach to work organization and problem-solving.
* A proactive mindset focused on process improvement and operational excellence.
* Proven ability to manage multiple high-priority tasks simultaneously in a fast-paced environment.
* Exceptional team player with the capability to collaborate with and influence multiple stakeholders.
* Demonstrates flexibility, a strong willingness to learn, and a commitment to going the extra mile.
Applicants from diverse backgrounds, including those returning after a career break or with transferable skills from non-traditional career paths, are encouraged to apply. We value varied experiences and are committed to fostering an inclusive environment that supports individuals with disabilities.