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
