Are you interested in taking the next step in your career with a global leader in biologics? Are you a scientist looking to progress your career and support the discovery, development and manufacturing of novel medicines? You could be the perfect candidate for this opportunity! Don't hesitate, apply today!
Job Description
Our client in Dundalk are seeking a QC Raw Materials and Compendial Scientist to be responsible for performing and supporting quality control testing of raw materials and compendial assays critical to biologics manufacturing
Key Responsibilities
- Ensure safe startup and routine operation of QC Raw Materials and Compendial laboratory functions.
- Support laboratory setup, equipment installation/qualification, and facility qualification activities.
- Develop and maintain quality systems (SOPs, documentation, training materials).
- Perform or support test method development and validation, and routine testing strategies.
- Author and review technical documents including protocols, validation reports, SOPs, etc.
- Participate in investigations (OOS/OOL), change controls, CAPAs, and quality events.
- Monitor laboratory KPIs and manage stock of reagents and consumables.
- Support internal and external audits and regulatory inspections.
- Train and mentor QC analysts and other personnel on methods and procedures.
- Engage with cross-functional teams and clients as needed.
Key Requirements
- GMP laboratory experience 3+ years
- Experience with pharmacopoeia, monographs (EP, USP, JP)
- Experience with compendial testing: pH, osmolality, appearance, KF.
- HPLC experience
- Technical writing capabilities: with experience on quality event systems such a Trackwise and ability to write deviations, laboratory events, CAPAs, change controls etc.
- Previous project management experience an advantage but not essential
- Highly motivated individual required who is a 'go-getter', able to work independently and meet deadlines.
Benefits
- Competitive and attractive employee compensation package
- Pension contributions
- Health insurance
- Paid holidays
Location: Dundalk, Ireland | on-site
