Senior Quality Assurance Associate

Title: Senior Quality Assurance Associate

Contract Length:12 Months

Pay rate: €34 - €38/hour

Work Schedule: Monday - Friday, 37.5H/W

Location: Dun Laoghaire, Dublin, Ireland

Role Overview:

Our client is looking for a Senior QA Associate to join their QA Team at their fill/finish facility. The successful candidate with serve as the Quality point of contact for Incoming Inspection of Primary and packaging components, and will be responsible for the release of primary packaging components within the IQA functional area.

Some of the key responsibilities for the Sr. QA Associate will include:

• Testing of primary and secondary components for use in the manufacture of aseptic products.
• Sampling of Excipients and Drug Substance under Grade C conditions.
• Compiling, Review and approval of minor NC and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable.
• Provide training and advice to staff in relation to testing of components and packaging.
• Write, review and approve Standard Operating Procedures in accordance with the site's Policies
• Support continuous improvement and Operational Excellence initiatives.

The successful candidate must have:

• Must Pass Eye-Tests which is required for Visual Inspection
• University degree. Engineering or Science related discipline preferred.
• Relevant experience (4 yrs. +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.

Skills and experience:

• Excellent written and verbal communication skills.
• Experience working with dynamic cross-functional teams and proven abilities in decision making
• Strong organisational skills, including ability to follow assignments through to completion
• Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non-Conformance /Deviation investigations
• Experience working in aseptic operations, protein formulation, vial and syringe filling.
• Must be flexible to move to shift if needed

Does this sound like you? If so, please apply today!

Get in touch to discuss this role!

My number is 020 7 551 0727

jkirlew@i-pharmconsulting.com