Search Results: 9 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...
...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...
...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...
...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!...
...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,...
...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...
...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...
...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,...
...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...