Senior Specialist External Manufacturing Quality Service

Next Generation (Ireland); Dublin; On-site; EUR 45,000 - 65,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

GMP QC experience

Analytical troubleshooting

Project management

Independent working

Matrix teamwork

Electronic document management

Third-party management

Education

Bachelor's in life science

Job description

Senior Specialist, External Manufacturing

Quality (Analytical)

A 12-month analytical quality contract with a global biopharmaceutical company in Dublin, overseeing testing at contract manufacturers and contract labs.

About the role

Our client makes a large share of its products through external partners. This role is the analytical quality lead for that network, covering testing of regulatory starting materials (RSM), intermediates, active pharmaceutical ingredients (API) and drug product.

You will be the main analytical contact for contract manufacturing organisations (CMOs) and contract testing laboratories (CTLs). You will work within Virtual Plant Teams: cross-functional teams that manage each externally made product as if it were made in-house.

It suits a QC laboratory specialist who wants to move into a broader quality oversight role, working with third parties and global functions.

What you'll do

Analytical oversight of CMOs and CTLs

• Provide analytical expertise and troubleshooting support across the external manufacturing network.
• Plan and manage product testing at CMOs and CTLs with internal and external stakeholders.
• Act as the analytical contact for CMOs and CTLs, resolving issues and requests with the right teams.
• Prepare sample submission forms and track shipment, receipt, testing and release status.
• Make sure reference standards and critical reagents are supplied on time.
• Review and approve lab investigations, deviations and out-of-specification (OOS) results at CMOs and CTLs, with method experts.
• Give technical support to the Qualified Person (QP) and Quality Operations on these events.
• Lead investigations for major analytical deviations in the electronic quality system.
• Review and approve analytical change controls from CMOs and CTLs, and assess the impact of internal changes on external testing.
• Raise internal change controls for analytical changes affecting CMOs and CTLs. Methods, transfers and stability
• Coordinate communication between CMO/CTL analytical teams and global functions, including testin standards, reference standards, QC strategy and microbiology.
• Manage method and specification updates to CMOs and CTLs.
• Support analytical technical transfers to CMOs and CTLs.
• Review method validation, transfer and verification against ICH guidelines, and manage gap remediation.
• Work with the global stability team and Virtual Plant Teams on CMO stability programmes.

Wider quality support

• Support internal and external audits as the QC laboratory subject matter expert.
• Support review of sample plans, Annual Product Quality Reviews (APQRs), risk assessments and quality agreements.
• Coordinate data requests from CMOs and CTLs.
• Assist with analytical sections of regulatory submissions.
• Support Procurement with requests for proposal (RFPs) for testing services.

What you'll bring

Essential

• 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.