QC Analyst

PE Global; Carlow; Híbrido; EUR 42.000 - 62.000; Jornada completa

Descripción de la vacante

PE Global is recruiting a QC Analyst for a pharmaceutical client in Carlow on an initial 11-month contract. The role focuses on cGMP compliance, analytical testing (HPLC, ELISA) and QC team collaboration in a fast-paced environment.

The position requires a Bachelor's degree in Analytical Chemistry or Biochemistry and 4+ years of pharma laboratory experience, with a solid knowledge of HPLC and ELISA/SoftMax Pro software. Visa to live and work in Ireland is required.

Formación

• Bachelor's degree in Analytical Chemistry or Biochemistry or closely related discipline.
• 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.

Responsabilidades

• Support QC activities under the QC Manager, ensuring compliance with cGMP/cGLP and global policies.
• Participate in QC Tier 1 daily meetings and communicate testing progress and deviations.
• Draft and revise SOPs, training materials and QC procedures; ensure alignment with quality systems.
• Perform analytical testing using HPLC/ELISA/compendial assays in line with GMP requirements.
• Peer review testing documentation and ensure data integrity and QC Right First Time KPIs.
• Assist with OOS investigations and audits/inspections as required.
• Drive continuous improvement, perform root cause analysis on equipment failures and system issues.

Conocimientos

HPLC

ELISA

SoftMax Pro

cGMP

GLP

Educación

Bachelor's degree in Analytical Chemistry

Herramientas

HPLC software

ELISA software

SoftMax Pro

Descripción del empleo

The Role

PE Global are recruiting for a QC Analyst for our pharmaceutical client based in Carlow. This is an initial 11-month contract role.

The team works a 2-cycle shift pattern. 7am-3pm week 1. 3pm-11pm week 2

Job 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

Education & Experience

• 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

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland****