Senior Quality Assurance Associate
| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | QualityOperations & Manufacturing |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 3339 |
| Job Views | 207 |
- Description
Team Horizon is seeking a Senior Quality Assurance Associate for our Client, who are a leading biotechnology company based in Dublin.
Why you should apply:
- This is an excellent opportunity to join a forward thinking company and work in a state of the art facility.
What you will be doing:
- 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 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.
- Actively participate in audits and their preparation.
- Review cGMP records (e.g., WO, JP, GDMS, NC, CAPA, protocols, reports, SOP, etc.) ensuring compliance with appropriate documentation
- Write, review and approve Standard Operating Procedures in accordance with Policies
- Perform all activities in compliance with safety standards and SOPs
- Support continuous improvement and Operational Excellence initiatives
- Any other tasks/projects assigned as per manager’s request
What you need to apply:
- 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.
- Excellent written and verbal communication skills
- Experience working with dynamic cross-functional teams and proven abilities in decision making Strong organizational 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.
