Quality Operations Technician City North at PCI Services in Stamullen, Co. Meath, IRL

Job description

• Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
• We are PCI.
• Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
• We are looking for a Quality technician to join our Stamullen, Co Meath Team.

Responsibilities

• Generate Packaging Instructions, Batch Packaging Records and labels for use in production from Master documents.
• Perform AQLs as required during production operations.
• Sampling, approval and release incoming goods, packaging materials and product (where required) for use in production.
• Request Certificates of Analysis / Conformance for incoming goods, packaging materials and product from customers/suppliers. Review and filing of same.
• Review and filing of stock cards, approval forms, equipment LUMAC logs and other production logbooks.
• Identify training needs in conjunction with the production manager and conduct staff training as required.
• Assist with environmental monitoring procedures, update spreadsheets to facilitate trending of results.
• Ad-hoc checks, in-process checks and documentation review on a routine basis on production lines.
• Approval of Line clearance procedures.
• Approval of Pre-production samples.
• Maintenance of batch documents and retain samples in archive. Update the PQR database after QP release.
• To liaise with Customers / suppliers for artwork related queries and management of approval of artwork.
• Raise Deviations, Corrective Action Requests, Non-Conformance reports as required and in a timely manner and ensure that issues are communicated to the QC Manager/designee.
• Ensure activities observed are in compliance with the requirements of cGMP.
• Assist in performing validation studies.
• Ensure safe work practices are being followed at all times, report any defects immediately to the Safety Officer and attend Health & Safety meetings.
• Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
• Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company

Requirements

• Degree and/or relevant experience
• Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Skills

Required

• Degree and/or relevant experience