Senior QC Associate

Life Science Consultants; Dublin; On-site; EUR 55,000 - 75,000; Full time

Job summary

Life Science Consultants seeks a Senior QC Associate for a South Dublin based Biopharmaceutical company specializing in Formulation, Fill Finish and Packaging. This contract role requires 3+ years in pharma/biotech and strong QC/CGMP knowledge.

You will support QC systems (LIMS, Empower, LMES, CIMS), provide end-user training, contribute to data integrity and 21 CFR Part 11 compliance, and assist with audits and validations.

Stamp 1G/Stamp 4 visa eligibility is required to apply in Ireland.

Qualifications

• 3+ years in biotech, pharma or GMP environment.
• Experience with LIMS/LMES/CIMS/Empower.
• Knowledge of cGMP, CV, Data Integrity and 21 CFR Part 11 for computerised systems.

Responsibilities

• Provide laboratory administration and technical support for QC systems (LIMS, LMES, CIMS, Empower).
• Build, develop and maintain LIMS templates; support LMES eProcedure implementation and SOP updates.
• Provide end-user training for QC laboratory applications.
• Review and approve Quality Documentation including sample plans, FORMs and Environmental Monitoring sample plans.
• Support Computer System Validation and Data Integrity activities in line with GAMP 5, Annex 11, PIC/S and 21 CFR Part 11.

Skills

QC GMP

DIA

TPBN1_IJ

Education

Science degree

Tools

LIMS

LMES

CIMS

Empower

Job description

Job Description

LSC have a great contract opportunity for a Senior QC Associate to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging. If you have 3+ years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you! ABOUT THE PROJECT - KEY RESPONSIBILITIES: Provide laboratory business administration, implementation and technical support for QC systems including LIMS (Thermo SampleManager), Biovia SmartLab (LMES), Biovia CIMS and Empower. Build, develop and maintain LIMS templates and support LMES eProcedure implementation, including CIMS and SOP updates. Provide end-user support and training for QC laboratory applications and work closely with site Business Process Owners and laboratory SMEs. Review and approve Quality Documentation including sample plans, FORMs and Environmental Monitoring sample plans. Contribute to Computer System Validation and Data Integrity activities in line with GAMP 5, Annex 11, PIC/S and 21 CFR Part 11 requirements. Support continuous improvement initiatives for laboratory applications as well as audit and inspection preparation and participation. ABOUT YOU - ARE YOUR SKILLS A MATCH? Third-level qualification in a Science-related discipline with 3+ years' experience in a Biotechnology, Pharmaceutical or GMP-regulated environment. Previous experience using LIMS, LMES, CIMS and/or Empower, with knowledge of QC laboratory operations and analytical laboratory techniques. Knowledge of cGMP, Computer System Validation, Data Integrity Assessments and 21 CFR Part 11 requirements for computerised systems. Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply! Skills: QC GMP DIA TPBN1_IJ