Compliance Officer - Supply Chain (Full Time)
Loughrea, Ireland
Description
To proactively lead and manage the day-to-day Quality Assurance function across Chanelle Pharma’s Supply chain departments (Procurement, Planning and Warehousing). The role will be responsible for all aspects related to quality compliance and execute tasks on quality documents such as change control, deviations, CAPA, FMEA whilst ensuring compliance to the Quality Management System.
Location: Onsite in our Loughrea facility (5 days per week)
As a Compliance Officer – Supply Chain, you will be responsible for:
* Being the overall compliance owner in the assigned functional area.
* Reporting any issues or gaps identified and taking the appropriate actions and points of escalation.
* Ensuring all quality reports are written and approved within the required timeframe by the department.
* Creating, leading & reviewing process investigations and risk assessment documents to ensure any such investigations are documented appropriately with relevant corrective actions, if necessary.
* Raising, investigating, and reviewing compliance documents e.g., Change Controls, Deviations, SCARS, Reject Notices, and CAPAs.
* Conducting routine Quality Audits of the department to ensure compliance and proactively resolving issues which may arise.
* Being the single point of contact for investigations in the assigned area.
* Providing and updating existing Quality Procedures such as Standard Operating Procedures (SOPs) in line with GMP regulations.
* Providing compliance training and coaching within the supply chain department.
* Being present on GMP and VM walks and taking appropriate actions from these activities.
* Contributing to the overall improvement of the company from a Quality/GMP perspective with an emphasis on continuous improvement of the quality system.
* Supporting or where necessary leading Quality based projects within the department including working as part of a multidisciplinary team as required.
* Participating in self-inspections, internal and regulatory audits and ensuring necessary corrective actions are put in place.
* Assisting the Procurement team in the creation of Approved Supplier Packs.
* Supporting and participating in Change Control meetings and the monthly ‘Quality Management & Review’ meeting.
* Any other duties assigned by the direct Line Manager.
Education & Experience:
* Bachelor’s degree in quality or science-based discipline.
* Minimum of 2-4 years’ experience in a GMP manufacturing environment with working knowledge of EU GMP and US FDA Guidelines essential.
* Experience working in pharmaceutical preferred; however, medical device industry experience will also be considered.
* Excellent report writing and IT skills.
* Demonstrated hands-on experience of delivering a best-in-class QA function in a similar role.
* Excellent communication and interpersonal skills.
* Analytical, methodical and structured approach to organizing their work.
* Ability to manage multiple critical priorities.
* Exceptional team playing skills with the ability to manage multiple stakeholders.
* Displays flexibility and shows willingness to learn and do that little bit extra.
* Working knowledge of Quality Risk Management regulations and best practices.
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.
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