Quality Operations Technician City North

PCI TRGR Penn Pharmaceutical Services Ltd; Ireland; Remote; EUR 32,000 - 46,000; Full time

Job summary

PCI TRGR Penn Pharmaceutical Services Ltd in Stamullen, Co Meath, Ireland, is seeking a Quality Operations Technician to support packaging, release of materials and line clearance on production lines.

The role involves generating instructions, performing AQLs, reviewing documentation, and ensuring cGMP compliance. It requires a degree and/or relevant experience and offers exposure to environmental monitoring and deviation management.

Qualifications

• Degree and/or relevant experience required.

Responsibilities

• Generate Packaging Instructions, Batch Packaging Records and labels for production from Master documents.
• Perform AQLs as required during production operations.
• Sampling, approval and release of incoming goods, packaging materials and product from customers/suppliers; review and filing.
• Review and filing of stock cards, approval forms and production logs.
• Identify training needs with production manager and conduct staff training as required.
• Assist with environmental monitoring procedures and data trending.
• Ad-hoc checks and documentation review on production lines and line clearance approvals.
• Raise Deviations, CAPAs and NCRs and communicate with QC Manager.

Education

Degree in a relevant field

Job description

## Quality Operations Technician City NorthApply: Stamullen, Co. Meath, IRL: Full time: Posted Today: JR119686Life 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 companyEssential* Degree and/or relevant experience