Basic Role Summary:
This is an opportunity to be part of a dynamic team within the QA function.
We are looking for individuals who will support and drive Chanelle Pharma's vision to be the most valued global provider of high-quality, competitively priced pharmaceutical products and to provide excellent services and support to our customers.
In this role, you will report to the Senior QA Compliance Manager.
Location:
Onsite at our facility in Loughrea.
As our QA Supplier Compliance Officer, your key responsibilities will be as follows:
Take overall responsibility for supplier management activities.
Maintain Approved Supplier Lists (ASLs) and ensure supplier compliance across APIs, excipients, and primary packaging components.
Coordinate sample evaluation and collate supplier compliance documentation, including GMP certificates, CEPs, TSE, GMO, allergens, elemental impurities, written confirmations, and other regulatory requirements.
Ensure all supplied materials comply with registered specifications.
Complete and maintain API Technical Agreements with suppliers.
Manage vendor performance and generate associated management reports as required.
Establish and maintain records of supplier performance and conduct vendor evaluations for new suppliers and materials.
Support final supplier approval processes, liaising with cross-functional teams when implementing changes.
Assist in the evaluation of materials proposed for R&D products.
Clarify supply chain routes, including manufacturers, brokers, agents, and transport companies, and collate associated compliance documentation.
Obtain supply chain route validation where required.
Clarify and ensure compliance with required storage and transport conditions for all materials.
Manage supplier risk assessments.
Ensure supplier-related procedures are written, implemented, and adhered to.
Ensure all activities are performed in compliance with regulatory standards and company policies, and that relevant personnel are trained accordingly.
Identify and implement approved improvements to the Quality Management System.
Carry out any other duties assigned by the Head of Quality or QA Manager.
Qualifications and Experience:
Bachelor's degree in a science-related discipline.
Minimum of 3 years' experience in a similar Quality Assurance role within the pharmaceutical industry desirable.
Knowledge of EU quality-related pharmaceutical regulations.
Skills and Competencies:
Strong organisational, time-management, and prioritisation capabilities.
Ability to build strong working relationships and collaborate effectively across teams.
Strategic and influential approach to decision-making.
Strong working knowledge of best-practice quality processes and change management.
Ability to prioritise key initiatives, drive performance, and work to defined KPIs.
Positive, proactive, and motivated by responsibility.
Practical, action-oriented approach to managing workload and priorities.
Strong computer skills, particularly in Microsoft Office.
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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