Search Results: 15 vacancies
...sheet reconciliations
Drive process improvement initiatives to deliver on business objectives
Deliver full compliance with all regulatory requirements, including the support of external and internal audits.
Variance Analysis – monthly management accounts must be...
...fit‐for‐purpose and future proofed application environments.
• Follow the OT lifecycle management processes that meet or exceed regulatory expectation in respect of data integrity: data backup regimes and system recovery testing.
• Creation of technical documents required...
...development?
The Role
We have an exciting opportunity within our Biologics Division located in Ballina, Co. Mayo, Ireland for a Quality/Regulatory Compliance Manager to join the team on a permanent, full-time basis. Reporting to the Senior Director, Regulatory Compliance, you’ll...
...methodologies to meet client requirements and/or company strategic objectives.
Draw up study plans / protocols ensuring full GMP regulatory compliance, where appropriate.
Execution of study plans and / or complex methods in the laboratory for transfer / validation / method...
...ICH guidelines, where appropriate.
-Draw up study plans and implement studies in strict accordance with study plan ensuring full GMP regulatory compliance as appropriate.
-Liaise with the Quality Department for the generation of audit responses, deviation reports and for...
...domestic and abroad) up to 50% of the time.
About Biologics Testing Solutions
With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies...
...compliant Data capture forms, SOPs, Protocols and reports. • Carry out data calculations and simple statistics.
-Assist in internal, regulatory and client visits/audits and respond to findings
-Sourcing, purchasing and stocking consumables, standards and reagents required...
...-Generation of GMP compliant SOPs, Protocols and reports.
-Carry out data calculations and basic statistics.
-Assist in internal, regulatory and client visits/audits and respond to findings.
-Sourcing, purchasing and stocking consumables, standards and reagents required for...
...Experience of aseptic cell culture techniques desirable.
Experience in in-vitro bioassays highly desirable.
Basic understanding off regulatory guidelines desirable.
Ability to problem solve and work on own initiative.
About Biologics Testing Solutions
With more than...
...Experience of aseptic cell culture techniques desirable.
-Experience in in-vitro bioassays highly desirable.
-Basic understanding off regulatory guidelines desirable.
-Ability to problem solve and work on own initiative.
About Biologics Testing Solutions
With more than 50...
...manufacturing and suppliers to resolve issues and to disposition materials.
Work with Quality Manager to support audits with external regulatory agencies (Notified Body’s and Competent Authorities) and customers.
Write and review validation protocols and reports to support...
...to achieve department and site goals
~ Experience liaising with other departments to schedule/coordinate work
~ Experience with regulatory compliance ISO9001, ISO14001 and ISO50001 preferred.
~2D/3D CAD skills (AutoCAD or equivalent preferred)
~ Project management skills...
...project objectives and deliverables.
Conduct technical reviews and provide feedback on design documents ensuring compliance with regulatory requirements and project specifications.
Drive innovation and continuous improvement in mechanical engineering processes leveraging...
...candidate will be responsible for the ongoing maintenance and repair of all mechanical equipment in their Value Stream in compliance with regulatory and corporate requirements. A significant feature of this role is to minimize equipment downtime thus optimizing overall plant...
...characterize and measure the performance of the product
Providing technical R&D support to other functions including Global Marketing, Regulatory Affairs, Engineering and Manufacturing.
Managing project schedules, conducting product and project risk analysis and ensuring...