- Generation and Execution of Moulding, Automated and Manual Assembly Lines Validations
- Support Measurement Methods Validation(s)
- Support Equipment and Facilities Qualification and Validation
- Execution of Computer Systems Validation.
- Management of Validation and Quality activities related with NPI (new programs introduction) on site.
Key Responsibilities and End Results: (Essential responsibilities include but are not limited to the following):
- Write the necessary Quality and Validation documentation required by the Quality Management System, ensuring compliance with regulatory bodies (FDA, HPRA, NSAI) directives / requirements applicable to the Medical Device and Pharmaceutical Sectors.
- Generate and support the execution of Master Validation Plans, Validation/Qualification Protocols and Validation/Qualification Reports covering moulding, assembly, facilities,
- Close liaison and networking with other departments (Quality, Operations, Supply Chain, Programs), to provide and drive quality and validation inputs, training and quality driven initiatives into the overall operational activities of the company.
- Support the implementation of Company Policies and GMP.
- Establishing validation strategies for NPI programs within multidisciplinary teams.
- Recording and resolution of QMS events and processes including change control, deviation, non-conformances, CAPA using the principles and tools for problem solving and risk management.
- Generation of computer systems validation protocols and reports.
- Ability to fully prepare for Internal/external Audits and Regulatory bodies Inspections & execute accordingly
- Liaise with internal and external Clients to facilitate the approvals of validation documentation and strategies as well as resolution of quality/validation issues occurred during the programs lifecycle.
- Support all company safety and quality programs and initiatives, including audits, risk management and Lean six sigma.
- Ensure ongoing compliance with GMP in all practices, recording of events and processes.
- Ensure compliance with all learnings from all GMP training events.
- Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.
Job Specifications : The minimum education and experience required to perform this job competently.
- Degree in Engineering/Science discipline.
- 3 to 5 years’ experience in a Validation/Quality Engineering role on a Medical Device/Pharmaceutical regulated environment (EudraLex, Annex 11 and annex 15, EN ISO 13485:2016, GAMP 5, FDA 21CFR Part 11, FDA 21CFR Part 820).
- Strong working knowledge of Process Validation on the areas of Moulding and Assembly Processes, Computer System Validation, Test methods and Facilities (cleanrooms) Validation.
- Experience of Problem-Solving Practices and Tools (Lean six sigma).
- Working experience of Risk Analysis practices and tools.
- Working knowledge of Sterilization Validation an advantage
- Working knowledge of Primary and Secondary Packaging Validation an advantage.
- Report Technical Writing essential
- Excellent organisation, communication, computer, & presentation skills.
- Excellent initiative, decision-making and be able to work in a core team environment attaining resolutions.
- Performance and Results driven
Organization Linkages: List the titles of individuals and organizations with which this position has the most frequent and significant contact. Briefly describe the nature of those contacts.
- Reports to Senior Quality Engineer.
- Department Managers and Employees.
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