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Quality compliance manager

Dublin
beBeeCompliance
Quality compliance manager
Posted: 1 August
Offer description

Job Title: Quality Operations Lead

Description:

* We are seeking a highly skilled and experienced professional to lead our quality operations, ensuring compliance with regulatory requirements and maintaining the highest standards of quality.
* Responsibilities include oversight and maintenance of the Quality Management System (QMS) to guarantee its effectiveness, approval of Standard Operating Procedures (SOPs) and quality system documentation, and maintenance of compliance with relevant authorisations, including WDA, MIA, and ASR.
* The ideal candidate will have experience as a Qualified Person (QP) under EU GMP regulations and be eligible to act as a Responsible Person (RP) under EU GDP guidelines.
* Liaison with the Health Products Regulatory Authority (HPRA) is also required, as well as support for HPRA inspections and preparation of written responses.
* Additional responsibilities include quality aspects management for new product introductions, review and approval of non-conformances, Corrective Action Preventative Actions (CAPAs), change controls, and complaints, and ensuring Good Manufacturing Practice (GMP)-compliant batch record review before release.
* This role also involves preparation, update, and review of technical agreements with partners and third parties, conducting internal audits and management reviews, and implementing continuous improvement initiatives within quality operations.
* BSc (Hons) in Science or equivalent qualification is required, along with eligibility to act as a Qualified Person (QP) under Directive 2001/83/EC and 2003/94/EC, and preference for eligibility to act as a Responsible Person (RP) per EU GDP guidelines.
* A minimum of 5 years experience in Quality Assurance within the healthcare industry, strong understanding of Good Distribution Practices (GDPs) and regulatory expectations, experience with internal audits and HPRA inspections, excellent analytical, communication, and leadership skills, and ability to travel as needed, are essential for this position.
* Collaborate effectively with cross-functional teams, foster a culture of continuous improvement, and contribute to the development and implementation of strategic plans that drive business growth.

Requirements:

* Eligibility Criteria: BSc (Hons) in Science or equivalent, eligibility to act as a Qualified Person (QP) under Directive 2001/83/EC and 2003/94/EC, and preference for eligibility to act as a Responsible Person (RP) per EU GDP guidelines.
* Experience: Minimum 5 years experience in Quality Assurance within the healthcare industry, preferably with a focus on pharmaceuticals or medical devices.
* Skills: Strong understanding of Good Distribution Practices (GDPs) and regulatory expectations, excellent analytical, communication, and leadership skills, ability to travel as needed.

About Us:

Our company specializes in recruitment services, providing expert knowledge and expertise in various sectors. We strive to deliver exceptional service to our clients and candidates, fostering long-term relationships built on trust and respect.

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