Quality Control Analyst

PE Global; Carlow; On-site; EUR 42,000 - 60,000; Full time

Job summary

PE Global are recruiting a QC Analyst for a pharmaceutical client based in Carlow. The role operates on a 2-cycle shift pattern (7am-3pm week 1, 3pm-11pm week 2) as part of the Quality Control team.

Bachelors degree plus 4+ years in a pharma lab is preferred; experience with HPLC, ELISA and SoftMax Pro is desirable. The position requires adherence to cGMP/cGLP and QA/QMS standards.

Qualifications

• Bachelor's degree or higher in Analytical Chemistry, Biochemistry or closely related discipline.
• 4+ years of experience in a pharmaceutical laboratory.
• Working knowledge of HPLC systems and software.
• Working knowledge of ELISA and SoftMax Pro software.
• Knowledge of cGMP, GLP and Quality Management Systems.

Responsibilities

• Support QC Manager in daily activities and ensure compliance with GMP policies.
• Participate in QC Tier 1 daily meetings and communicate testing progress.
• Draft, revise and roll out SOPs and training materials for QC systems; ensure alignment.
• Operate as part of the QC team performing designated testing and review.
• Perform analytical testing including ELISA/ HPLC/ compendial assays in GMP.
• Peer review testing documentation and maintain data integrity and QC KPIs.

Education

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

Tools

HPLC

ELISA

SoftMax Pro

Job description

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****