QA SNR ASSOCIATE with at least 4 years Inspection experience required by CareerWise Recruitment for our BioTech client in South County Dublin, initial 9 month contract on offer.
The QA SNR ASSOCIATE will be responsible for sampling and testing of incoming raw materials/excipients and components. They will be a core member of the site Quality Assurance team and will report to a QA Senior Manager.
Role of this position
- Clean room raw material Sampling required in accordance with procedural requirements
- Proficiency in ANSI sampling of excipients, chemicals, primary and secondary packaging.
- Inspect Raw Materials and Components in accordance with site procedures
- Send Samples for Test to QC or Contract Laboratories in accordance with material Specifications
- Compile, Review/approve incoming batch related documentation and associated documentation in preparation for disposition activities.
- Write, review and approve Standard Operating Procedures in accordance client Policies.
- Provide Quality support for triage and investigation of non-conformances (NC's)
- Responsible for drafting NC's and CAPA's
- Participates in customer complaint investigations as required.
- Provides training and advice to staff in order for them to perform their desired functions.
- Maintain the site reserve/retain samples program
- Review and approve cGMP records (e.g., WO, JP, GDMS, NC, CAPA, protocols, reports, SOP, etc.) ensuring compliance with appropriate documentation
- Support continuous improvement and Operational Excellence initiatives
- 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.
- Experience working in aseptic operations, protein formulation, vial and syringe filling.
- Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues
- Operational Excellence experience.
Please call Conor Twomey today for further information on 021 4297422 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)