Lead QC Analyst

Aphex Group; Carlow; Vor Ort; EUR 65.000 - 90.000; Vollzeit

Zusammenfassung

Aphex Group is seeking a QC Lead Analyst to support laboratory expansion, lead analytical method transfers and validation, and oversee commercial testing. The role operates in a 2-cycle shift pattern with occasional training travel.

You will drive cGMP/cGLP compliance, contribute to SOPs and training materials, and collaborate with the QC team to ensure data integrity and timely results.

Qualifikationen

• Bachelor's degree or higher in Analytical Chemistry/Biochemistry or closely related field.
• 4+ years of experience in a pharmaceutical laboratory.
• Good working knowledge of HPLC systems and software.
• Good working knowledge of ELISA and Softmax Pro software.
• Good knowledge of cGMP, GLP, and Quality Management Systems.

Aufgaben

• Work under the QC Manager to ensure compliance with cGMP/cGLP and regulatory requirements.
• Participate in daily QC meetings and communicate testing progress and deviations.
• Help write/ revise standard operating procedures and training materials for QMS.
• Perform testing and review as part of QC team.
• Utilise ELISA, HPLC and compendial assays in GMP-compliant work.
• Peer review data integrity and QC KPIs.
• Assist in OOS investigations and audit readiness.
• Support internal and external audits and inspections as auditee.
• Contribute to continuous improvement using RCA tools (FMEA, Fishbone, 5 Why).
• Promote a safe and compliant culture in Carlow.

Kenntnisse

Analytical Chemistry

Biochemistry

Regulatory compliance

Quality systems

Ausbildung

Bachelor's degree in Analytical Chemistry/ Biochemistry

Tools

HPLC software

Softmax Pro

Jobbeschreibung

Purpose

The QC Lead Analyst will report directly to the QC Manager and will help us in the expansion of this Laboratory and complete analytical method transfers and validation as well as commercial testing.

The team works a 2-cycle shift pattern.

Occasional travel may be required for training purposes.

Responsibilities

• Work as directed by the Quality Control Manager according to Company safety policies, cGMP and cGLP. Required to drive compliance with Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions
• Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc
• Participate in writing/revising/ rolling out accurate operational procedures, training materials and maintenance procedures for various Quality systems; ensure all work is carried out in line with same
• Operate as part of the QC team performing the allocated testing and review
• Perform various analytical techniques including but not limited ELISA/HPLC/Compendial Assays in compliance with GMP requirements
• Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved
• Participate in the laboratory aspects of OOS investigations
• Provide support with audit/inspection requirements to ensure department compliance/readiness.
• Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
• Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 why's etc,
• Work collaboratively to drive a safe and compliant culture in Carlow.

What skills you will need

In order to excel in this role, you will more than likely have:

• Bachelors Degree or higher preferred; ideally in Analytical Chemistry/ Biochemistry or a closely related discipline
• 4+ years of experience in a pharmaceutical laboratory
• A good working knowledge of HPLC systems and software is desirable
• A good working knowledge of ELISA and Softmax Pro software is desirable
• A good knowledge of cGMP, GLP, Quality Management Systems