Plant Technical Quality Assurance Specialist
12‑month contract (potential extension) with Berkley Group, senior QA role reporting to a QA Manager.
Responsibilities
* Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities for aseptic products.
* Review and approve Process Development and Validation documentation, technical transfer documents, validation protocols and reports.
* Provide quality direction and input at Change Control and Deviation Review Boards and oversee change control/Deviation/CAPA records.
* Ensure all activities comply with safety standards and SOPs.
* Additional duties may be assigned as required.
Basic Qualifications
* University degree in Science or Engineering (preferred).
* Understanding of validation principles and New Product Introduction.
* Experience in aseptic manufacturing.
* 7+ years experience in pharma/biotech as a subject‑matter expert providing overall quality direction across Process Development, Validation, and Manufacturing.
* Experience in change control, non‑conformance, CAPA and validation practices.
* Strong analytical, communication, coordination, and teamwork skills.
* Ability to work independently and remotely with minimal supervision.
Contact
David O'Connell
Phone: +353 86 126 3871
Email: doconnell@berkley-group.com
Berkley Life Science & Engineering – specialist consultancy recruiting in Ireland – www.berkley-group.com
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