Jobs for "Change control bangor" at Grifols 1 -10 of 135 (0.001s)

Senior validation engineer

DublinGrifols

...and validation procedures/standards* Review change controls and assess impact of changes that affect validated systems and define validation requirements* Represent Validation at both internal and external audits by regulatory agencies, including HPRA and FDA.* Generation and review of project documentation [...]

Category Manufacturing & Production

19 hours ago in Experteer

Labelling hub manager

DublinCpl

...Management System and Trackwise Change control environment as needed to show compliance with global submission timelines and a valid reason for delay. Liaise with Translation vendors as needed. General knowledge of preparing artwork from labelling text and the interface with Launch Management, Supply Chain and Quality teams. [...]

Category Management & Consulting

19 hours ago in Experteer

Head of quality operations/responsible person

DublinCpl

...quality parameters, Deviation and Change Control; presenting recommendations to the Pharma Affairs management to maintain process under control and/or to further improve the process.· Presents regularly performance reviews against measures relating to the Pharma Affairs GDP related operations objectives at [...]

Category Banking, Insurance, Finance & Accountancy

19 hours ago in Experteer

Senior process engineer

LimerickCAI

...process equipment, piping, and control systems.* Review and update P&IDs and Process Flow Diagrams (PFDs).* Prepare engineering evaluations, technical risk assessments, and change control documentation.* Ensure full compliance with GMP, safety, and regulatory standards.* Support investigations into process [...]

Category Engineering & Architecture

1 day ago in Experteer

Senior c&q engineer

LimerickCAI

...Project teams.* Support deviations, change controls, CAPAs, and regulatory inspections.Qualifications* Degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related discipline* 5+ years' experience in Commissioning & Qualification / CQV / Validation* Strong working knowledge of GMP requirements, FDA and EMA [...]

Category Engineering & Architecture

1 day ago in Experteer

Senior automation engineer

AthloneAlexion Pharmaceuticals

...obsolescence roadmaps, and access control reviews for DCS, PLCs, historians, and servers to safeguard operations.* Vendor and Partner Management: Manage third-party vendors and system integrators for both project delivery and sustaining activities to ensure quality, timelines, and value.* Technical Leadership: Provide guidance [...]

Category Engineering & Architecture

1 day ago in Experteer

Quality specialist engineer

RingaskiddyEurofins

...and guidance on investigations, change controls, and compliance activities, ensuring adherence to regulatory standards and fostering continuous improvement within the maintenance and engineering functions.Job Responsibilities:* Provide oversight and expert guidance on investigations related to Maintenance/Engineering activities [...]

Category Engineering & Architecture

1 day ago in Experteer

Automation infrastructure engineer

LimerickRegeneron Pharmaceuticals

...line with the site change control procedures* Implementing and reporting of preventative maintenance, patching & upgrades* Developing a plan for system obsolescence, vendor support and upgrade schedulingThis role might be for you if you:* Have some experience with cGMP and validation pertaining to biopharmaceutical production [...]

Category Engineering & Architecture

1 day ago in Experteer

Associate director/director pharmacoepidemiology project manager (pepm)

Cork

...and make adjustments and changes (per change control process) as needed to meet the deliverables of the trial. Timeline – Develop and track global pharmacoepidemiology trial alignment and integrating inputs across functions and geographies. Provide consultation and guidance to PE scientists on their [...]

Category Management & Consulting

1 day ago in RecruitIreland

Associate director - quality control laboratories

Limerick

...world.Position Title:    Associate Director-Quality Control Laboratories Reporting To:    Senior Director QC laboratories Lilly is currently constructing a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This facility will be Lilly’s most technically advanced manufacturing [...]

Category Management & Consulting

1 day ago in RecruitIreland