Direct message the job poster from Planet Pharma
Client Dedicated Talent Acquisition Partner at Planet Pharma
Role: Quality Assurance Specialist
Contract: 11 months contract initially with possibility of extension
Location: Fully on-site in Clonmel, Ireland
Company: A Global Pharmaceutical Company
Job Purpose
The Specialist is part of the Quality team and plays a key role in supporting GMP Quality Assurance activities.
Key Responsibilities
* Review and approve production and analytical documentation related to the release of drug substances, drug products, and packaged finished goods, ensuring compliance with SOPs, GMP, and regulatory requirements, including support for QP certification.
* Conduct and review investigations for complaints, deviations, change controls, and CAPAs.
* Develop and maintain assigned SOPs.
* Compile and analyze data for reports and presentations, drawing meaningful conclusions.
* Perform audits to ensure adherence to SOPs, GMPs, and applicable regulations.
* Support product recalls and stock recoveries as required.
* Collaborate with cross-functional teams to foster strong working relationships and resolve issues arising during audits and reviews.
* Identify compliance gaps and recommend continuous improvement initiatives.
* Assist in onboarding new employees and training team members.
* Follow standard procedures and consult with the manager/supervisor on exceptions.
* Execute all tasks with a focus on compliance, efficiency, innovation, accuracy, and safety in alignment with company and regulatory standards.
* Stay updated on cGMP requirements and relevant global regulations.
* Represent the department in cross-functional teams.
* Perform additional responsibilities as assigned by the manager/supervisor.
Skills & Qualifications
* A degree in Science or Engineering with relevant industry experience, or significant industrial experience in a related field.
Seniority level
Not Applicable
Employment type
Contract
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing and Chemical Manufacturing
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