QA Specialist Clinical Trial Supply / IMP Compliance
QA Specialist Clinical Trial Supply / IMP Compliance
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Job Description
We are seeking an experienced Quality Assurance (QA) Specialist to join our Global Development Quality (GDQ) team which plays a pivotal role in supporting global GMP Quality Assurance activities for the Investigational Medicinal Product (IMP) licence at our Ballydine site. The site is responsible for the release of all clinical lots to clinics across the EU and globally.
The successful candidate will be part of a collaborative and high-performing team comprising Quality Specialists and Qualified Persons (QPs) working closely with partner teams in the UK Switzerland and the US to ensure the integrity of the Clinical Supply Chain.
Key Responsibilities:
- Audit and review batch documentation to ensure compliance with SOPs cGMPs and applicable regulations.
- Review and approve production and analytical documentation related to drug substance drug product and packaged finished goods supporting QP certification.
- Maintain effective communication and collaboration with cross-functional teams to foster strong working relationships and a clear understanding of responsibilities.
- Resolve comments and issues arising during audits and documentation review by leveraging internal networks.
- Manage product recalls and stock recoveries in accordance with procedures.
- Identify compliance gaps and recommend continuous improvement initiatives.
- Author and maintain assigned Standard Operating Procedures (SOPs).
- Conduct and review complaint investigations deviations change controls and CAPAs.
- Support induction and training for new hires and team members.
- Follow standard operating procedures and escalate exceptions to the manager/supervisor as needed.
- Compile interpret and present data for reports and business updates.
- Ensure all tasks meet standards for compliance efficiency accuracy safety and innovation as per internal and regulatory requirements.
- Stay current on global cGMP regulations and best practices.
- Represent the QA department on cross-functional project teams.
- Assist with the generation review and approval of Technical and Quality Agreements.
- Perform additional duties as assigned by the manager/supervisor.
Requirements
Skills and Qualifications:
- Bachelor s degree in a Quality Science or Engineering discipline (Master s degree or equivalent industrial experience preferred).
- Minimum of 3 years of experience in the pharmaceutical or biotech industry with a focus on cGMP quality assurance.
- Strong understanding of cGMP regulations and regulatory compliance for clinical supplies.
- Excellent verbal and written communication skills.
- Strong interpersonal skills and ability to work collaboratively across global teams.
- Proven ability to handle multiple priorities and adapt to dynamic environments.
Bachelor s degree in a Quality, Science, or Engineering discipline (Master s degree or equivalent industrial experience preferred). Minimum of 3 years of experience in the pharmaceutical or biotech industry, with a focus on cGMP quality assurance. Strong understanding of cGMP regulations and regulatory compliance for clinical supplies. Excellent verbal and written communication skills. Strong interpersonal skills and ability to work collaboratively across global teams. Proven ability to handle multiple priorities and adapt to dynamic environments.
Employment Type
Full Time
