Senior Specialist External Quality Assurance

PE Global is currently recruiting a fully remote, Senior Specialist External Quality Assurance for a 11 month contract, with a leading multi-national Pharmaceutical client.

This is initially a fully remote 11month contract position, reporting into the Carlow site of a pharmaceutical client.

Duties of the role/Responsibilities

• Evaluate and/or release products with the assurance that the goods were manufactured in conformance to all applicable policies/procedures of the Company and compliance with all governing regulations.
• Review and approve changes to master batch records or laboratory methods/specifications.
• Master batch record review and approval
• Executed batch record review.
• Preparation of Annual Product Review
• Provide support during audits.
• Review and approval of change controls
• Accountable for ensuring metrics are compiled, analyzed, and reported, including identification of trends and/or root cause(s) to help develop new initiatives and process improvements.
• Assures compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc) both domestic and foreign.
• Accountable for oversight of an EE involving releasing of products with the assurance that the goods were produced or tested in conformance to all applicable policies and procedures of the Company and compliance with all governing regulations.
• Accountable for Quality Control functions including oversight for product testing, as well as other relevant components as determined by applied Calibrated Quality Oversight. These components may include review of batch documentation, complaints and deviation investigations.

Education/Experience

• Minimum of 5 years relevant experience in the pharmaceutical industry and/or biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements. (Assessed personnel with less experience i.e. minimum 2-3 years will also be considered for P2 role)
• Communicates in English, both verbally and in writing.
• Must have strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships.
• Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Chloe on 086 0200448 or alternatively send an up-to-date CV to chloe.slingsby@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***