Sr Associate Quality Control (NPI)
RK3200
Contract – 12 months
On Site - South Dublin

We’re currently recruiting for an exciting opportunity with a Biopharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

This role will be the QC representative for NPI activities and routine product meetings. You will support QC and manufacturing operations and some extended hours and weekend work flexibility may be required.
The successful candidate will have:

• Bachelors degree in a science field
• 2-3 years experience in QC or GMP lab experience gained in a biopharmaceutical environment. Pharmaceutical and medical device experience will also be considered.
• Experience in regulatory compliance to cGMP in manufacturing and testing of pharmaceutical products
• Strong background in Chemistry and Analytical testing required

• Demonstrate exceptional technical adaptability by seamlessly transitioning across various functions within Quality Control (QC).
• Strategize and execute analyses with efficiency and precision.
• Execute multiple intricate routine and non-routine methods and procedures, encompassing a wide array of assays.
• Compile, evaluate, securely back up, analyze trends, and authorize analytical findings.
• Proactively troubleshoot issues, devise solutions, and engage stakeholders effectively.
• Spearhead the initiation and implementation of revisions in controlled documents.
• Provide comprehensive training support as needed.
• Actively participate in audits, organizational initiatives, and projects, spanning departmental or organizational dimensions.
• Draft protocols, execute assay validation, and oversee equipment qualification/verification processes.
• Introduce innovative techniques to the laboratory setting, overseeing method transfers, report generation, validation procedures, and protocol development.
• Contribute to regulatory filings, ensuring adherence to compliance standards.
• Lead laboratory investigations as required.
• Continuously assess laboratory practices for compliance adherence.
• Authorize laboratory outcomes, ensuring accuracy and reliability.
• Act as a representative of the department/organization across various teams and in interactions with external partners.
• Facilitate data analysis by creating APPX data files and randomization memos.
• Oversee LIMS data coordination for commercial and import testing where applicable.
• Offer technical guidance and support to colleagues.
• Engage in regulatory filings and represent the department/organization on diverse teams.
• Mentor and train team members.
• Foster collaboration with external resources to achieve organizational objectives.