...verify that tasks are being performed to the required expectations.
Keeping records in an audit ready state. Ensuring all required GMP and technical documentation is generated and assuring compliance with GMP guidelines and written procedures.
Ability to handle multiple...
Thermo Fisher Scientific Inc.
Moate, Co. Westmeath
17 hours ago
...validation, and process.
Review and execution of Factory Acceptance Testing and Site Acceptance Testing protocols.
Directly supports GMP and regulatory audits.
Prepare and deliver training modules as required.
Perform data analysis and make informed decisions / recommendations...
...filtration techniques, and sampling.
Prepare and operate equipment according to written procedures (SOPs)
Assist with setting up the GMP areas for batch production including received materials, stock counts and performing cleaning tasks.
Sanitization of the WFI loop...
...validation, and process.
Review and execution of Factory Acceptance Testing and Site Acceptance Testing protocols.
Directly supports GMP and regulatory audits.
Prepare and deliver training modules as required.
Perform data analysis and make informed decisions /...
...deliverables such as process optimization, design verification, stability, packaging and validation qualifications. You will adhere to GMP based Quality Systems requirements for medical devices and medicinal product (e.g. MDD, EU GMP Guidelines Vol IV Part 1 for medicinal product...
...industry experience, may be considered in Lieu of Degree Qualification
· Previous relevant industry experience
· Previous experience in a GMP/GLP environment
· Experience in the performance management of teams
· Up-to-date knowledge of regulatory guidelines relevant to...
...Relevant Laboratory experience using multiple laboratory techniques.
Desirable Criteria
· Previous relevant industrial experience in a GMP/GLP environment
Additional Criteria information
Please note, we are recruiting for various grades of Analytical Development...
...lieu or degree.
· Experience of multiple laboratory techniques
Desirable Criteria
· Previous relevant industrial experience in a GMP/GLP environment
· Meticulous attention to detail and methodical in review of documents and processes
Additional Criteria...
...identification and specification review of alternatives and associated implementation efforts
CAPA Management & generation and a dherence to GMP
Communicate project status and escalates issues to direct manager, program managers, internal and external partners in timely...
...and investigated in a timely manner
Ensure Batch records (run files) are competed in full as per Work Instructions and adhering to GMP requirements before transfer to the Quality team for release, ensuring deviations for items are highlighted to the Quality department...
...and analyses data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP). Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance...
Remote job
...Sunday 08:00 to 20:00
Fourth Shift: Monday – Tuesday Rest days
Wednesday – Thursday 20:00 to 08:00
Friday – Sunday Rest days
KEY Competencies
Leaving Cert, Quality focused, Co-ordination skills, Manual Handling, GMP, GDP...