permanent basis. The roles will be responsible for and carry out the following functions - Leadership role within the Quality Department responsible for the management and co-ordination of the site cGMP validation activities. Support validation activity during design, installation & commissioning of new equipment, processes, packaging lines & facilities and … auditors. Execute validation protocols and drive to completion any CAPA associated with non-conformances raised. Use quality risk management tools (e.g., FMEA, System Impact Assessments) to ensure that risks are appropriately identified, documented and managed. Ensure product quality through robust testing and process monitoring including the use … of statistical techniques. Support Cleaning, Utilities and Computer System Validation. Essential skills/experience and qualifications Degree in a relevant science or engineering discipline with a minimum 5 years of validation and qualification experience in a cGMP regulated life science industry, Pharmaceutical, API or Bio-tech. Excellent day/ more »
materials (presentations, briefings, reports) and to communicate effectively with stakeholders at all levels in various global locations. 9. Sound experience of the project management lifecycle. Desired Skill 1. Proven ability to quickly interpret and translate complex requirements to fit within an existing Governance Model. 2. Experience and/… communicate and influence stakeholders across various teams and various corporate grades. 5. Strong analytical skills, understanding of complex issues, ability to quickly absorb information, conceptual and creative problem-solving excellence. 6. Proven ability to adapt to new systems and tools, using them to a high standard and quickly … Impairments PMO lead to meet internal and regulatory requirements. 5. Provision of project analytics and reporting, including but not limited to maintenance of management dashboards and executive summaries, provision of MI on change control, finances, RAIDS, etc. with supporting commentaries and insights. 6. Track and monitor consistency of more »
Glenrothes, Fife, United Kingdom Hybrid / WFH Options
Raytheon
notes with regard to relevance for SAP operations Perform detailed planning & project management of implementation activities for updates & patching where required Perform system health audits to validate system status & report to SAP Service Owner Perform effective Operational Reviews as required with SAP Service Owner Ensure integrity …/Spool Management Workload issues in SAP SAP Process Management Application of Support Packs & Support Stacks Preform Kernel Upgrades Preform system refresh/copies. Preform system client copies Monitoring of Integration with PI systems ERP & BI System monitoring Batch Management (Redwood … SAP client Management Security Management(SOD, new roles built) ALE/IDOC Admin SQL Database administration(Space management) System Maintenance(stop/start, profile parameters etc) Archiving of tech. objects Netweaver Admin Java administration and troubleshooting XI Basis administration SOLMAN Administration (SMSY, MOPZ more »
and responsibility for technical and administrative decisions for the laboratory in collaboration with the laboratory director(s). Other critical aspects include project management, budget development and maintenance; management of supplies and resources, administrative oversight of team member issues including hiring, competency assessment, development and corrective … 2. Manages the day-to-day operations of the laboratory based on patient care needs, regulatory requirements, and quality standards. 3. Interpret laboratory information for healthcare providers. Effectively communicate implications and/or applications of test methodologies. Assist clinicians in evaluating unexpectedly abnormal test results. 4. Uses effective … qualified Clinical Laboratory Technologist, OR Candidate with appropriate master's degree must have at least four years of pertinent laboratory experience, AND Extensive management experience required. COMMUNICATION SKILLS: Ability to: 1. Communicate clearly and effectively both orally and in writing. Use available communication technologies efficiently. 2. Create meetings more »
defined parameters. Create profiles for the clients Induction. Support the HSEQ manager with quality related issues. Various other ad-hoc duties, including data management and filing; Scanning and saving all project related information onto the Drives. Experience, Qualification and Attributes: - Understanding Quality Management Systems. more »
Ayrshire during an exciting period of expansion and growth. The Validation Specialist responsibilities include: Leadership role within the Quality Department responsible for the management and co-ordination of the site cGMP validation activities. Support validation activity during design, installation & commissioning of new equipment, processes, packaging lines & facilities and … validation documentation including site Validation Master Plan and Site Validation Strategy. Support Production departments in validation activities for processes and equipment. Preparation and management of validation plans, protocols and reports. Supporting external audits including customer and regulatory inspections, presenting and explaining relevant validation information to inspectors … auditors. Execute validation protocols and drive to completion any CAPA associated with non-conformances raised. Use quality risk management tools (e.g., FMEA, System Impact Assessments) to ensure that risks are appropriately identified, documented and managed. Ensure product quality through robust testing and process monitoring including the use more »
role purpose and the field: • Working in 3D model and carry out written tasks. • Working to design standards/rules • Understanding of cable management tools/CM pick, read access and PC equipment. • Carry out investigations into operational problems or developments and develop and prepare solutions, individually or … are technical reviews to ensure product viability. • Appreciates and can articulate the need to ensure that products are acceptably safe and that product and system safety assessments form part of the design process. • Has had some exposure to regulatory and statutory requirements of the product and understands potential liabilities. … are technical reviews to ensure product viability. • Appreciates and can articulate the need to ensure that products are acceptably safe and that product and system safety assessments form part of the design process. • Has had some exposure to regulatory and statutory requirements of the product and understands potential liabilities. more »
in their absence. KEY RESPONSIBILITIES AND ACCOUNTABILITIES Support colleagues across the organisation with specialist advice and practical guidance on the implementation of privacy management policies and procedures. Assist in the recording, monitoring, and reporting of risks associated with data processing activities and identify actions that can be taken … to mitigate risk. Assist in the preparation of reports to the Trusts Board and Executive Committee through the collation of key managementinformation, including case management statistics and updates on the delivery of training. Support the annual review of all privacy management … stakeholders to contain, recover and respond to data breaches and cyber security incidents acting as the key contact for external stakeholders, including the Information Commissioners Office, OSCR and Police Scotland, in the absence of the DPO. Support the delivery of data protection and cyber security projects as required. more »
