Production Operator - Level 3

PCI TRGR Penn Pharmaceutical Services Ltd; Dundalk; On-site; EUR 35,000 - 45,000; Full time

Job summary

A leading pharmaceutical services provider in Dundalk seeks a Production Operator - Level 3. The role involves ensuring product quality and compliance with Good Manufacturing Practices. Responsibilities include conducting inspections, documentation of batch records, and collaboration with team members. This position requires flexibility for shift changes and adherence to safety practices. Ideal candidates will demonstrate a strong commitment to quality and operational excellence.

Qualifications

• Ability to ensure product quality and adherence to specifications.
• Experience with batch packaging record documentation.
• Understanding of safety procedures and regulations.

Responsibilities

• Ensure all product produced conforms to specifications.
• Conduct sampling tests and visual inspections.
• Document and report deviations to the supervisor.
• Achieve competency levels as per training plan.

Skills

Quality Control

Good Manufacturing Practice

Machine Operation

Team Collaboration

Safety Compliance

Job description

Production Operator - Level 3 page is loaded## Production Operator - Level 3locations: Dundalk, Co. Louth, IRL: IRL\_City North: IRL\_Donore Roadtime type: Full timeposted on: Posted Todayjob requisition id: JR117603Life 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.Thursday- Saturday night shift (7pm - 7am)Responsible, in conjunction with the immediate supervisor for shift output, quality and yield incompliance with the requirements of current Good Manufacturing Practice.Responsibilities• Ensure that all product produced conforms to the approved specification.- All materials required for the batch are booked in and documentedaccurately and conform to the packaging instruction & batch packagingrecord.- Sampling tests are carried out at the required frequency.- Visual inspections are carried out at required frequencies.- Liaise with the QA dept. for support in area / line clearances along withany other specific quality issues which may arise during production.- Approval of area / line clearances and pre-production samples asrequired as per defined procedures.- QC samples are collected as per the batch packaging record.- Ensure consistent adherence to operating, quality and machine cleaningand safety procedures in production.- Deviations are reported to the immediate supervisor.- Yields are being monitored versus goals & timely corrective actions arebeing taken.- Machine downtime is being actioned in a timely fashion.• Achieve the desired level of competency as per the relevant training plan.• Ensure that all batch packaging records are completed accurately in a timely manner.• Ensure that quantities of good & rejects are accurately recorded.• Ensure excellence in Housekeeping and that cleaning logbooks, LUMAC logs andother production-floor logs are completed and kept up to dateWork positively with all Team Leaders, Engineers and Packaging Manager/ BusinessUnit Manager at all times.• Ensure safe work practices are being followed at all times and report any defectsimmediately to the Safety Officer / Packaging Manager/ Business Unit Manager.• This role demands flexibility to changes in shift patterns at short notice.• Carry out various other additional tasks that may be required from time to time inaccordance with the overall goal of the company.• Assist in all technical aspects and projects as and when required by the PackagingManager.Join us and be part of building the bridge between life changing therapies and patients.**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. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.*###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.