QC – NPI

The role

PE Global are currently recruiting for a Senior QC Associate on behalf of a multinational biopharmaceutical client based in Dublin South. This role is an initial 12 month contract.

Role Name: QC Senior Associate – 12 month

Role purpose: QC Senior Analyst (QC NPI)

Primary Responsibilities

Plan and Perform non-core chemical analytical high volume NPI testing activities in adherence with agreed testing turnaround time

QC Representative for NPI activities and routine Product meetings

• Assist with activities related to QC projects and/or QC tasks within Site projects
• 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
• 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.

Job Summary:

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.

Specific Job Duties:

• 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.
• 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.

Relevant experience:

• Bachelor’s degree in a Science related field is required.
• 3+ years of bio/pharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry,
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.

Experience in both Wet Chemistry and HPLC testing techniques

Extensive experience in laboratory systems such as sample management LIMS, Velquest / Smartlab, Empower software etc.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Audrey on 0214297900 or alternatively send an up to date CV audrey.mccarthy@peglobal.net

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