Search Results: 20 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...
Collins McNicholas Recruitment
Castlebar, Co. Mayo
3 days ago
...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...
...Monitoring, Sterility) experience in a GMP Environment with experience in support of Aseptic Manufacturing ideally
• Strong knowledge of Regulatory Requirements
• Excellent communication skills
So, does this all sound like the right role for you? Then come join Abbvie!...
...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...
...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...
...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 the...
...(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 worldwide...
...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...
...laboratory investigations where necessary.
Responsible for reporting progress information to Management.
Assist in internal, regulatory and client visits/audits and respond to findings.
Complete understanding off all regulatory guidelines.
Liaise with the Quality...
...manufacturing, supply chain and supporting functions & areas of the site
Ensure cyber resiliency, compliance and data integrity regulatory standards are maintained and adhered to across all site systems
Lead the site BTS organisation with performance transparency (e.g...
...in batch processing, automation, commissioning and validation in an FDA/HPRA regulated industry.
~ Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required for this role.
~ Comprehensive understanding of the principles of...
...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...
...equipment and technology in the BU. Generate and approve associated change controls and relevant protocols.
Help support the BU during regulatory and compliance audits.
Qualifications
~ Third level qualification in Mechanical, Electrical or Process Engineering.
~+4...
...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...
Recruit Island
Castlebar, Co. Mayo
1 day ago
...medical device industry
~ Prior knowledge of aseptic practices in clean room environments is essential.
~ Strong knowledge of GMP regulatory guidelines, quality systems, drug product manufacturing and validation is desirable
~ Understanding of autoclave sterilization,...
...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,...
...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...
...technical issues and problem solving. Experience working with control / networked system would be preferrable.
Detailed knowledge of regulatory requirements in a pharmaceutical GxP environment.
Technical knowledge of both procedural controls and system controls for managing...
...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...
