GMP Production Operator II: Quality, Yield & Shifts

PCI Pharma Services; Leinster; On-site; EUR 28,000 - 45,000; Full time

Job summary

PCI Pharma Services in Ireland is seeking a Production Operator to ensure that batch output meets the approved specifications and quality standards within GMP. You will be responsible for documenting materials, performing sampling and inspections, and coordinating with QA for area/line clearances.

You will monitor yields, action downtime, maintain batch packaging records, and uphold housekeeping and safety standards while collaborating with Team Leaders, Engineers and the Packaging Manager.

Qualifications

• Capability to meet clear goals, communicate clearly and ensure progress to completion meeting predefined targets.
• Fluent English

Responsibilities

• Ensure that all product produced conforms to the approved specification.
• All materials required for the batch are booked in and documented accurately and conform to the packaging instruction & batch packaging record.
• 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 with any other specific quality issues which may arise during production.
• Approval of area / line clearances and pre-production samples as required as per defined procedures.
• QC samples are collected as per the batch packaging record.
• Ensure consistent adherence to operating, quality and machine cleaning and safety procedures in production.
• Deviations are reported to the immediate supervisor.
• Yields are being monitored versus goals & timely corrective actions are being 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 and other production-floor logs are completed and kept up to date.
• Work positively with all Team Leaders, Engineers and Packaging Manager at all times.
• Ensure safe work practices are being followed at all times and report any defects immediately to the Safety Officer / Packaging 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 in accordance with the overall goal of the company.
• Assist in all technical aspects and projects as and when required by the Packaging Manager.

Skills

Goal orientation

Clear communication

Job description

PCI Pharma Services in Ireland is seeking a Production Operator to ensure that batch output meets the approved specifications and quality standards within GMP. You will be responsible for documenting materials, performing sampling and inspections, and coordinating with QA for area/line clearances.

You will monitor yields, action downtime, maintain batch packaging records, and uphold housekeeping and safety standards while collaborating with Team Leaders, Engineers and the Packaging Manager.