Senior Associate Quality Control

Senior Associate Quality Control

12 Months

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical 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.

Ideally the person will have general test methods product samples. Eg Ph, Appearance, Colour, Clarity, Protein Concentration, Moisture, etc., along with technical writing experience. This person needs to have experience planning and performing multiple, complex routine/non-routine methods & procedures, and should have conducted lab investigations within a biopharmaceutical, pharmaceutical or medical device industry.

Duties:

• Plan and perform analyses with great efficiency and accuracy.
• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
• Report, evaluate, back-up/archive, trend and approve analytical data.
• Troubleshoot, solve problems and communicate with stakeholders.
• Initiate and/or implement changes in controlled documents.
• Participate in audits, initiatives and projects that may be departmental or organizational in scope.
• Review protocols and perform assay validation and equipment qualification/ verifications when required.
• Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
• May contribute to regulatory filings.
• May conduct lab investigations as necessary.
• Evaluate lab practices for compliance on a continuous basis.
• Approve lab results.
• May interact with outside resources.
• LIMS data coordination of commercial and import testing on site where applicable
• May represent the department/organization on various teams and may train others.

• Hold a Bachelor’s degree in a Science related field is required.
• 3+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
• Have strong technical writing skills (e.g. updating SOP) and investigation skills.
• Experience with analytical techniques such as Compendial testing would also be advantageous
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.