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Quick apply
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QC/RA Officer

Merit Pharamceuticals
Swords, County Dublin

Quick apply

Job details

Part-time
From €20,000 a year
2 days ago

Benefits

Company pension
On-site parking

Qualifications

Packaging
Chemistry
Communication skills
Time management

Full job description

Job Description: Pharmaceutical QC/RA Officer (Part-Time)

Company Overview

Merit Pharmaceuticals is a leading pharmaceutical service provider specializing in secondary packaging, labelling, and serialization. We are dedicated to ensuring the highest standards of safety, quality, and regulatory compliance for life-saving medicines. We are currently seeking a detail-oriented, part-time Quality Control and Regulatory Affairs (QC/RA) Officer to join our team.

Role Overview

Position Type: Part-Time
Department: Quality Assurance & Regulatory Affairs
Location: Swords Ci Dublin (Secondary Packaging Facility)
Reports to: Quality Manager

Position Purpose

The Part-Time QC/RA Officer plays a vital role in ensuring that all secondary pharmaceutical packaging operations—including cartoning, labeling, kitting, and serialization—strictly comply with Good Manufacturing Practice (GMP) and local health authority regulations before products are released to the market.

Key Responsibilities

1. Pharmaceutical Quality Control (QC)

Line Clearances: Perform and document rigorous line clearance checks before and after packaging runs to prevent product mix-ups.
Component Inspection: Inspect incoming secondary packaging materials (cartons, labels, patient information leaflets) against approved reference artwork for accuracy.
In-Process Checks: Conduct regular checks during active packaging runs to verify batch codes, expiration dates, tamper-evident seals, and correct leaflet placement.
Serialization & Track-and-Trace: Verify that unique 2D data matrix codes and serial numbers are correctly printed and aggregated in compliance with drug safety laws.

2. Regulatory Affairs (RA) & Compliance

Batch Record Review: Review completed batch packaging records to ensure absolute accuracy and data integrity prior to final batch release.
Deviations & CAPA: Identify, document, and report any quality issues or process deviations. Assist in root-cause investigations and help implement Corrective and Preventive Actions (CAPAs).
Documentation Support: Maintain up-to-date Standard Operating Procedures (SOPs), Product Specification Files (PSFs), and regulatory logs.
Audit Readiness: Assist the Quality team during internal audits, external client inspections, and health authority audits.
Licencing – Maintaining licences and apply for new PPAs and CAPs

Qualifications and Experience

Education: Degree or Diploma in Pharmacy, Chemistry, Life Sciences, or a related technical field.
Experience: Experience in a GMP-regulated pharmaceutical packaging or manufacturing environment.
Regulatory Knowledge: Basic understanding of GDP/GMP guidelines and pharmaceutical serialization systems is highly preferred.

Skills and Competencies

Attention to Detail: An exceptional eye for identifying small errors in text, numbers, barcodes, and packaging alignment.
Communication: Clear verbal and written communication skills for writing technical reports and collaborating with packaging floor staff.
Organization: Strong time-management skills to efficiently balance quality tasks during a part-time schedule.
Integrity: High ethical standards regarding product quality and patient safety.

Pay: From €20,000.00 per year

Benefits:

Company pension
On-site parking

Work Location: In person

Quick apply

Refine Your Search

release manager jobs in finglas, d

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