Senior Associate Quality Control – NPI

PE Global (UK); Dún Laoghaire; On-site; EUR 45,000 - 60,000; Full time

Job summary

PE Global (UK) is seeking a Senior Associate Quality Control for a 12-month contract in Dún Laoghaire. The role involves performing comprehensive quality control analyses, troubleshooting issues, and ensuring compliance with regulatory standards in a multi-national pharmaceutical setting.

Ideal candidates will have a Bachelor’s in a science discipline and 2-3 years of biopharmaceutical QC experience, especially focusing on analytical testing and regulatory compliance.

Qualifications

• 2-3 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience.
• Strong background in Chemistry and Analytical testing is required.
• Experience with regulatory compliance in cGMP manufacturing and testing.

Responsibilities

• Plan and perform analyses with efficiency and accuracy.
• Report, evaluate, and approve analytical data.
• Troubleshoot and solve problems while communicating with stakeholders.
• Participate in audits and write protocols for assay validation.

Skills

Analytical testing

Chemistry background

Regulatory compliance

Problem-solving

Education

Bachelor’s degree in a science discipline

Job description

PE Global is currently recruiting for a Senior Associate Quality Control for a leading multi-national Pharma Healthcare client based in Dun Laoghaire.

This is an 12 month contract.

Role:

With a high degree of technical flexibility, work across diverse areas within QC

• Plan and perform analyses with great efficiency and accuracy.
• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
• Report, evaluate, back-up/archive, trend and approve analytical data.
• Troubleshoot, solve problems and communicate with stakeholders.
• Initiate and/or implement changes in controlled documents.
• May train others as necessary
• Participate in audits, initiatives and projects that may be departmental or organizational in scope.
• Write protocols and perform assay validation and equipment qualification/ verification.
• Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
• May contribute to regulatory filings.
• May conduct lab investigations as necessary.
• Evaluate lab practices for compliance on a continuous basis.
• Approve lab results
• May represent the department/organization on various teams
• May interact with outside resources.
• Create APPX data files and randomisation memo to facilitate data analysis.
• LIMS data coordination of commercial and import testing on site where applicable
• May provide technical guidance. May contribute to regulatory filings.
• May represent the department/organization on various teams. May train others.
• May interact with outside resources

Requirements:

• Bachelor’s degree in a science discipline.
• 2-3 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
• Strong background in Chemistry and Analytical testing is required.
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.

Interested candidates should submit an updated CV.

Please click the link below to apply, or alternatively send an up to date CV to [e-mail].

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