Snr Associate QC

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.

Duties

• Testing of raw materials, in process, stability and finished product samples. Eg Ph, Appearance, Colour, Clarity, Sub Visible Particle testing, Osmolality, Protein Concentration, Polysorbate, Moisture and Device testing.
• Review and authorisation of Lab Data
• Support Analytical Technical Transfer activity testing reports and documentation.
• Document review/updates when required.
• Monitoring of site water and Nitrogen systems.
• Equipment Calibration, Maintenance and Trouble Shooting.
• Method Validation/Verification.
• Training of QC Chemistry Laboratory colleagues.
• Laboratory Investigation support
• Laboratory Housekeeping and maintaining GLP standards.
• Assisting in regulatory audits.
• Commitment tracking and follow up
• Volume of samples, expelling content onto a balance, polysorbate, protein concentrate, UV, GC, Karl Fischer, some device testing. Container closures on vials and syringe. Mainly finished product and stability, high volume testing.
• There is a small about of raw materials, 1-2 that may come in from IQA.

• Complete testing, right first time, candidates would need the initiative to speak up, raise issues with manager/team also ability to look at safety issues/projects, continuous improvement projects

• Experience with most of the methodologies called out on the JD (Ph, Appearance, Colour, Clarity, Sub Visible Particle testing, Osmolality, Protein Concentration, Polysorbate, Moisture and Device testing) GC (Gas Chromatography) testing is a good one, moisture testing, use of a UV.

• GMP pharma is a MUST, right first time, good documentation practices. Ideal candidate with had continuous improvement projects. Candidates needs ideal 4 years testing experience, but a solid 2 year testing experience would be considered.