External Manufacturing Quality Lead – Analytical (Contract)

Next Generation (Ireland); Dublin; Presencial; EUR 45 000 - 65 000; Tempo integral

Resumo da oferta

Next Generation (Ireland) is seeking a Senior Specialist, External Manufacturing in Dublin to lead analytical quality oversight of the external network for regulatory starting materials, intermediates, APIs and drug products. You will act as the primary analytical contact for CMOs and CTLs, coordinating testing, investigations and change controls within global Virtual Plant Teams.

The role suits a QC laboratory specialist expanding into broader quality oversight, working across third parties and

Qualificações

• A degree (BA or BSc minimum) in a life science.
• 3 to 5 years' experience in a GMP QC environment, ideally in a pharmaceutical QC laboratory.
• Testing experience across RSM, intermediates, API and drug product.
• Thorough knowledge of global GMP requirements, with working knowledge of FDA and EU GMP.
• In-depth knowledge of quality management systems for laboratory operations.
• The ability to critique analytical investigation reports objectively.
• Proven troubleshooting and project management skills.
• Confidence working independently and in a matrix team.
• Experience with electronic document and deviation management systems.
• Working knowledge of analytical technical transfers.
• Experience managing third-party relationships, such as CMOs or contract labs.

Responsabilidades

• Provide analytical oversight of CMOs and CTLs and troubleshoot issues.
• Plan and manage product testing at CMOs and CTLs with internal and external stakeholders.
• Act as analytical contact for CMOs/CTLs and coordinate issue resolution.
• Prepare sample submission forms and track shipment, testing and release status.
• Ensure reference standards and critical reagents are supplied on time.
• Review and approve lab investigations, deviations and OOS results at CMOs/CTLs.
• Support QP and Quality Operations on events.
• Lead investigations for major analytical deviations in the electronic quality system.
• Review and approve analytical change controls from CMOs/CTLs and assess impact of internal changes.
• Coordinate communication between CMO/CTL teams and global functions.
• Manage method and specification updates to CMOs/CTLs.
• Support analytical technical transfers to CMOs/CTLs.
• Review method validation, transfer and verification against ICH guidelines.
• Work with the stability team and Virtual Plant Teams on CMO stability programmes.
• Support audits as QC lab SME.
• Support reviews of APQRs, risk assessments and quality agreements.
• Coordinate data requests from CMOs/CTLs.
• Assist with analytical sections of regulatory submissions.
• Support Procurement with RFPs for testing services.

Conhecimentos

GMP QC experience

Analytical troubleshooting

Project management

Independent working

Matrix teamwork

Electronic document management

Third-party management

Formação académica

Bachelor's in life science

Descrição da oferta de emprego

Next Generation (Ireland) is seeking a Senior Specialist, External Manufacturing in Dublin to lead analytical quality oversight of the external network for regulatory starting materials, intermediates, APIs and drug products. You will act as the primary analytical contact for CMOs and CTLs, coordinating testing, investigations and change controls within global Virtual Plant Teams.

The role suits a QC laboratory specialist expanding into broader quality oversight, working across third parties and