LSC have a great contract opportunity for a Quality Assurance Senior Associate to join a South Dublin based Biopharmaceutical company.
If you have 4 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
About the Project - Key Responsibilities:
- Testing of primary and secondary components for use in the manufacture of aseptic products.
- Sampling of Excipients and Drug Substance under Grade C conditions.
- Review/approve documentation associated with component testing in preparation for QA Specialist or Qualified Person disposition activities.
- Compiling, Review and approval of minor deviation's 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.
- Actively participate in audits and their preparation.
- Review and approve cGMP records (e.g., WO, JP, GDMS, Deviation, CAPA, protocols, reports, SOP, etc.) ensuring compliance with appropriate documentation.
Education/ Experience:
- University degree in Engineering or Science related discipline.
- 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.
- 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.
About you - Are your skills a match?
- Strong organizational skills, including ability to follow assignments through to completion.
- Excellent written and verbal communication skills.
- Experience working with dynamic cross-functional teams and proven abilities in decision making.
- Must Pass Eye-Tests required for Visual Inspection.
Note: Are you currently eligible to work in Ireland?
As this is a contract opportunity, you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Kathy Gillen on 021 4777329 if you have anymore questions about this role!
