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Qualified person

Sligo
Wallace Myers International
Posted: 3 February
Offer description

Jenn at Wallace Myers is currently partnering with a key global client to help them identify a Qualified Person (QP) for their state-of-the-art facility in Sligo.
This is a full-time, permanent staff role where you'll be joining a site at the forefront of innovation.
If you're looking for a move that combines global impact with the lifestyle benefits of the Northwest, lets chat
This is a staff role that comes with Competitive salary and benefits package.
The Qualified Person (QP) ensures pharmaceutical product quality, safety, and regulatory compliance throughout the entire manufacturing lifecycle, from production through to release.
This key role also provides technical leadership, guidance, and people management, including leading teams and supporting cross-functional project groups.
Responsibilities Provide technical leadership and guidance to functional areas, lead teams of up to 6 people, and support cross-functional teams and projects Collaborate with suppliers and internal/external stakeholders to maintain compliant, efficient relationships and optimized processes Ensure compliance with EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice, Annex 16, marketing authorisations, and all regulatory obligations Certify that batches are manufactured and checked per legal, GMP, specification, and authorisation requirements Oversee batch disposition (release or reject) based on comprehensive manufacturing and testing data Maintain review and completion of all necessary production and quality documentation, ensuring records are accurate and endorsed Assess and resolve daily quality issues and deviations, maintaining high standards of expertise and attention to detail Authorize and evaluate deviations or planned changes, participate in notification processes with regulatory authorities Ensure principal manufacturing and testing processes are validated, audit readiness maintained, and improvements driven Initiate and oversee additional sampling, inspection, tests, or checks as needed due to deviations or changes Continuously develop technical/scientific knowledge and expertise for existing and new product types Foster a culture of safety, EHS excellence, integrity, and continuous improvement within the organization Perform other duties as assigned Qualifications Bachelor's degree in a science discipline and 5+ years' experience in an FDA/EMEA pharmaceutical environment MSc (or equivalent) meeting QP qualification per Directive *******/EC, Article 49 2+ years' aseptic processing experience, preferably in a quality function Demonstrated decision-making, problem-solving, and communication skills Experience in leading teams and supporting cross-functional groups Experience as a QP on a license (preferred); sterile fill-finish manufacturing experience (desirable) All applications will be treated with the strictest of confidence Contact Jenn at Wallace Myers on Or email or via the link below At Wallace Myers International Recruitment Agency we specialise in sourcing professionals for key industries and services.
See our website for more details.
Privacy Policy: By applying for this role you are agreeing that your details will be stored in our database and may be considered for similar future positions.
For more info see Skills: QP Pharmaceutical Product Quality Compliance Benefits: pension healthcare bonus

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