Senior Quality Control Analyst

PE Global is currently recruiting for a Senior QC Associate Analyst for a leading multi-national Pharma client based in South Dublin.

This is a contract position.

Role:

Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing, characterization, sample and data management.

Contributes to team by ensuring the quality of the tasks/services provided by self

Contributes to the completion of milestones associated with specific projects or activities within team This role will support QC and manufacturing operations, as such some extended hours and weekend work flexibility may be necessary as required.

Responsibilities:

• QC Representative for NPI activities and routine Product meetings
• Assist with activities related to QC projects and/or QC tasks within Site projects
• Plan and perform non-core testing related to NPI activities
• Manage all sample management activities related to NPI activities throughout the site
• Create/own and approve protocols, sample plans, SOP and documentation related to NPI
• QC Representative responsible for Method Validation and Transfers co-ordination and readiness
• Responsible for their own training and safety compliance.
• Sample shipments and temperature monitoring activities for NPI activities
• LIMS data coordination of non-core (NPI) activities.
• 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.

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.
• Understanding and application of principles, concepts, theories, and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning
• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery

Interested candidates should submit an updated CV.

Please click the link below to apply, or alternatively send an up to date CV to [email protected]

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