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, let's chat!
This is a staff role that comes with competitive salary and benefits package.
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.
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