Job Description:
This is a high-level position in the Quality Assurance department responsible for leading specific quality management system elements such as GMP investigations, Change Control, CAPA and Risk Assessment and Customer Quality Complaints/Medical Device Vigilance systems.
Key Responsibilities:
* Lead GMP investigations, Change Control, CAPA, and Risk Assessment processes to ensure compliance with regulatory requirements.
* Support Qualified Person(s) in leading and performing data review audits (Batch Packaging Records, Warehouse Documentation, Engineering Documentation, Validation Documents and Development Documentation).
* Collaborate with the Quality Manager to define and maintain annual internal audit programs and quality management reviews.
* Support the quality organization in meeting growing business needs by applying technical expertise, skills, knowledge, and experience as required to resolve problems and share knowledge.
* Review and approve suppliers/service providers, including supporting audits of critical suppliers where necessary.
* Act as principal project quality lead for new and existing projects, providing advice and guidance to operational teams with support and guidance from the Quality Manager.
Requirements:
* Bachelor's degree in a Science related discipline or equivalent.
* Minimum 5 years relevant experience within a relevant sector (pharmaceutical/medical device industry), with at least 3 years' experience within a Quality Assurance role.
* Experience in Quality Assurance in a Pharmaceutical/Medical Device Packaging Department desirable but not essential.
* Strong working knowledge of Microsoft Office (Word, Excel, PowerPoint, etc.).
* Knowledge and/or experience of all quality system aspects, including Deviation management, CAPA, complaint handling, auditing, change management, supplier qualification, batch release.
Benefits:
We offer competitive salaries, benefits, and an inclusive environment where you can use your experiences, perspectives, and skills to make an impact on people's lives.
About Us:
We are a global company committed to improving healthcare outcomes through innovation and collaboration.