The Role of Quality Assurance Manager
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We are seeking a highly skilled and experienced Quality Assurance Manager to join our team. This is an exciting opportunity for a motivated individual to take on a key role in ensuring the quality of our products.
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In this position, you will be responsible for managing and maintaining our Quality Management System (QMS), ensuring that it is fit for purpose and aligned with regulatory requirements. You will also be responsible for providing QA expertise to our team, managing communications with regulatory bodies, and representing us at inspections and audits.
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Your key responsibilities will include:
* Managing the QMS, ensuring it is up-to-date and compliant with regulatory requirements;
* Maintaining quality processes and procedures, including SOPs and quality system documents;
* Providing QA expertise to our team, including training and support;
* Representing us at inspections and audits, including HPRA inspections and Bausch + Lomb internal compliance audits;
* Reviewing and approving Non-Conformances, CAPAs, change controls, and complaints;
* Ensuring annual review of supplier and customer bona fides to verify compliance with Guidelines on Good Distribution Practice;
* Ensuring batch record review to verify compliance with GMP and Market Authorization prior to batch release;
* Reviewing and approving technical agreements with licensees and 3rd party contractors;
* Regular presentation and review of intercompany Quality service provider performance against measures relating to the BLIL Quality Objectives;
To be successful in this role, you will need to have:
* A thorough working knowledge of GMDPs and regulatory expectations for medicinal products and medical devices;
* A minimum of 5 years of experience working in Quality Assurance in the Healthcare Industry;
* Strong communication and organizational skills, as well as excellent ability to deliver results;
* Ability to work on their own initiative and within teams, and to build relationships internally and externally;
* Trained auditor status;
* Availability to travel if required to fulfill the role.
If you have the skills and experience we are looking for, we would love to hear from you.
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