IRE_Quality Operations Technician

PCI TRGR Penn Pharmaceutical Services Ltd; Killiney; On-site; EUR 32,000 - 48,000; Full time

Job summary

PCI Pharma Services is seeking a Quality Technician to join our Stamullen Team in Ireland. You will generate packaging instructions and records for production from master documents, perform AQLs, and ensure proper sampling and release of incoming goods and materials.

You will review batch documents, manage artwork-related queries, raise deviations and CAPAs, and support training and environmental monitoring while maintaining cGMP standards. Essential degree 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 incoming goods, packaging materials and product for use in production.
• Request Certificates of Analysis / Conformance for incoming goods, packaging materials and product from customers/suppliers.
• Review and filing of certificates and batch documentation.
• Review and filing of stock cards, approval forms, equipment logs and other production logbooks.
• Identify training needs with the production manager and conduct staff training as required.
• Assist with environmental monitoring procedures and trend results.
• Ad-hoc checks and in-process checks on production lines.
• Approval of Line clearance procedures.
• Approval of Pre-production samples.
• Maintenance of batch documents and archive samples.
• Update PQR database after QP release.
• Liaise with customers/suppliers for artwork-related queries and approvals.
• Raise Deviations, CAPAs and NCRs and communicate issues to QC Manager.
• Ensure activities comply with cGMP requirements.
• Assist in performing validation studies.
• Follow safe work practices and report safety concerns.
• Carry out additional tasks to support company goals.

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 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.

Essential Degree and/or relevant experience

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies.

We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.