Recruitment Manager - Contracts at PE Global
The role:
PE Global is currently recruiting for a QA Operations Specialist on behalf of a leading pharmaceutical company based in Dublin. This is an initial 11-month contract role. It is a shift position.
Description:
* This is a shift role (4 x 12hr extended days followed by 4 days off).
* The Quality Specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Product Team). Under guidance from the Associate Director of Quality Operations, the specialist ensures product quality and compliance, adherence to cGMPs, and represents quality on the shop floor.
* Performs review of process documentation/data for accuracy, completeness, and data integrity compliance. May support batch disposition activities and assist in deviation investigations.
* Spends significant time on the shop floor providing quality coaching, ensuring documentation accuracy, and compliance with cGMPs and regulations.
Responsibilities:
* Review and approve Master Batch Records/Electronic Batch Records and production documentation.
* Support compliance and data integrity on the shop floor.
* Review and approve SOPs, Work Instructions, and Job Aids.
* Participate in Tier process and cross-functional projects.
* Support QA activities such as commissioning, qualification, change management, deviations, CAPAs, equipment requalification, and audits.
* Collaborate on continuous improvement initiatives.
Education and Experience:
* Bachelor’s degree in a scientific or engineering field (or relevant experience).
* Minimum 5 years of GMP manufacturing, QA, or laboratory experience in pharma/biotech.
* Experience with QA operations, regulatory engagement, and shop floor activities is advantageous.
* Strong communication, leadership, and interpersonal skills.
* Knowledge of cGMPs and regulatory requirements.
Preferred:
* Experience with GMP documentation, quality systems, and manufacturing processes.
* Analytical, critical thinking, and coaching skills.
* Experience on manufacturing shop floor and auditing.
Interested candidates should submit an updated CV. Please apply via the link, contact Audrey at 0214297900, or email CV to audrey.mccarthy@peglobal.net.
***Candidates must have the correct visa to work in Ireland; visa sponsorship is not provided.***
Additional Details:
* Seniority level: Mid-Senior level
* Employment type: Contract
* Job function: Science
* Industries: Pharmaceutical Manufacturing and Biotechnology Research
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