The successful candidate will provide quality compliance and validation support to Global Engineering and the DAMIT Department on computerized and automated processes.
Key responsibilities would include (but are not limited to):
· Responsible for tracking the Department’s metrics.
· To provide quality compliance and validation expertise in relation to the qualification of new computerized or automated systems and processes.
· To coordinate department change controls (where required).
· To drive and be responsible for Department deviation investigations and CAPAs (where required).
· To act as a point of contact and as an SQE SME during Internal Inspections for the company.
· To coordinate new Department project initiatives to ensure that they adhere to Validation and Quality requirements.
· To be aware of the latest GAMP 5 and Computerized System Validation guidelines (as appropriate).
· To liaise effectively with all Business Units, in carrying out the above work so that the requirements of each in terms of quality, cost and output are met.
· To follow up on qualification deviations.
· To support software validation activities when required.
· Liaise with Project Engineers to ensure any new or changed instrumentation is completed as per decommissioning/commissioning procedures.
· To promote good Cross-Departmental collaborations.
· To ensure that all work is to the highest standards and in compliance with all requirements i.e. LEO standards, FDA, GMP, GAMP, etc.
· To communicate effectively within the Department and in particular with all stakeholders/ customers.
· Ensure that all Site and Departmental procedures such as PPs, SOPs, WIs and Guidelines etc. are strictly adhered to.
· Pay due care and attention to Health and Safety and Environmental matters.
· To coordinate; write and technically review qualification test packs for computerized or automated systems as required.
· To drive and facilitate problem solving exercises such as A3 RCA investigations.
Qualifications & Key skills you should possess:
· Minimum 3-5 years’ experience in an Automation or Quality related role.
· The ideal candidate should have 3-5 years GAMP5 exposure, high level understanding of controls systems, SCADA, controllers, etc. Validation/qualification exposure with a quality mindset, using quality management systems.
· Strong problem-solving skills including leading A3 processes
· Ability to motivate & influence peers.
· Be able to build partnerships & work collaboratively with others to meet shared objectives.
· Strong communication skills including written and verbal skills.
· Competent understanding of regulatory guidelines.
· Be innovative, by creating new & better ways for the organisation to be successful.
· Have a strategic mindset, seeing ahead to future possibilities & translating them into breakthrough strategies.
· Drives results; motivated by success and passionate about working and achieving higher results. Persists to complete tasks / responsibilities, even in the face of difficulties.
· Self-starter with ability to complete work independently as well as successfully lead others if needed.
· Ability to work well with other technical staff in a collaborative, fast-paced goal-driven environment
· A “can do” attitude and genuine enthusiasm for driving improvements
· A positive mindset of Safety First
The deadline will be 26/10/2020.
For a full Job Spec and to apply for this role please call Zoe on +353 1 2784671 or e-mail email@example.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671