Quality Control Chemist

Morgan McKinley; Tipperary; On-site; EUR 42,000 - 64,000; Full time

Job summary

Morgan McKinley is assisting a leading pharmaceutical manufacturer in Tipperary to hire a Quality Control Analyst. The role focuses on preparing the lab for full operation, performing analytical testing, and supporting method validation and transfers.

Ideal candidates have 3–5 years in a cGMP QC environment, hands-on HPLC/GC experience, and solid GDP/cGMP knowledge to ensure regulatory compliance and audit readiness.

Qualifications

• 3–5 years in a cGMP Quality Control environment within pharma/biotech.
• Hands-on with HPLC, GC and balances; experience in method validation or transfer.
• Strong knowledge of GDP, cGMP, and Good Documentation Practices.

Responsibilities

• Assist in bringing the lab to full operational capability and establish procedures.
• Perform routine analytical testing and non-conformance investigations.
• Support method verification, validation and technical transfer projects.
• Oversee lab consumables, calibrations, and equipment qualification (IQ/OQ/PQ).
• Maintain audit readiness and liaise with external labs/suppliers during inspections.
• Collaborate with engineering, tech transfer and operations to resolve issues.

Skills

HPLC

GC

Balances

Method validation/transfer

GDP knowledge

cGMP awareness

Education

Bachelor's degree in Chemistry/QA

Job description

A leading and fast-growing pharmaceutical manufacturer in Tipperary is looking for a Quality Control Analyst to join their growing team. Working out of a state-of-the-art facility, the company specializes in producing advanced, high-value medicinal products, including respiratory therapies and specialized dosage forms.

This role offers a fantastic chance to play a key part in a site advancing toward full commercial scale, backed by significant ongoing investment in both production and R&D infrastructure.

Note: Applicants must hold valid work authorization for Ireland.

Key Responsibilities

• Operational Setup & Readiness: Assist in bringing the lab to full operational capability, establishing procedures, specifications, protocols, and technical reports.
• Testing & Quality Assurance: Perform routine analytical testing, non-conformance investigations, and peer review of test documentation following standard operating procedures (SOPs), cGMP, and global compliance guidelines.
• Method Transfer & Validation: Support analytical method verification, validation protocols, and technical transfer projects.
• Equipment & Inventory Management: Oversee lab consumables, perform routine instrument calibrations (e.g., analytical balances), and assist with equipment qualification (IQ/OQ/PQ).
• Audit Readiness & External Vendors: Help maintain an audit-ready facility, liaise with third-party testing labs/suppliers, and assist during regulatory inspections.
• Cross-Functional Collaboration: Partner with engineering, tech transfer, and operations teams to resolve technical issues and support site milestones.

Candidate Requirements

• Experience: 3 to 5 years in a cGMP Quality Control environment within the pharma or biotech sector.
• Instrumentation & Methods: Demonstrable hands-on expertise with key analytical tools (HPLC, GC, balances) alongside practical experience in method validation or transfer.
• Compliance & Documentation: Deep knowledge of cGMP standards, regulatory guidelines, and strict adherence to Good Documentation Practices (GDP).
• Problem Solving: Direct experience supporting out-of-specification (OOS) investigations, root-cause analysis, and CAPA execution.
• Inspection Prep: Familiarity with audit preparation and maintaining continuous compliance readiness.