- Reference: CJ000000000
- Job Type: Permanent
- Location: Munster
- Category: Bio-Pharmaceutical
Working within the Quality Support function of the QCoE, this role will provide Quality leadership, coordination, oversight and direction to the development, implementation and execution of process validation and technical transfer project activity. The Principal Quality Specialist – Quality Automation Support will fulfil the quality signatory role for cGMP requirements.
- • Provides to the site and network, expertise in Quality Automation Support
• Coordinates the work of others within the team and in the site
• Review and approval of equipment, computer system and laboratory analytical qualification activities (IQ, OQ)
• Review and approval of system support and process validation activities (e.g. steam/dry heat sterilisation/SIP processes/ Analytical and Micro methods)
• Providing Quality insight and direction on the planning and execution of engineering, process support projects (e.g. equipment/support process upgrades/ automation/ aseptic process improvements/ WFI improvements )
• Provide Quality insight and direction on planning and execution of new product introduction and technical transfer.
• Provide consultation, Quality oversight and expertise for computer systems projects. The Principal Quality Specialist – Quality Automation Support must be able to translate and give guidance on the regulations (e.g. 21 CFR Part 11), Company policies and regulatory terms and intent into language that is understandable to the customer/system owner.
• Acts as a resource to colleagues with less experience in Quality Support.
• Leads project teams
• Coaches and guides colleagues within the site and also in the network
• Interprets customer needs, assesses requirements and identifies solutions to non-standard requests
• Change control impact assessment and approval
• Makes decisions within guidelines and policies which impact projects
• Liaises with corporate Quality to ensure alignment on actions related to projects at the site
• Work with other sites to aid them in Quality Automation Support related topics
• Support for QCoE group as appropriate
• Degree or 3rd level qualification (Science, Quality, Engineering).
• Desirable evidence of Continuous Professional Development.
• A minimum of seven years system validation / Quality engineer experience in biotechnology, pharmaceutical or medical device industry.
• Experience in Distributed Control Systems
• Experience in DeltaV desirable
• Experience in manufacturing / laboratory equipment and process validation.
• Experience working as part of a large, multi-disciplinary team completing full project lifecycle implementations.
• Knowledge and experience in interpreting current regulatory requirements and providing independent support to a manufacturing operation.
• Process and Quality background.
• Demonstrated ability to fully realize improvement initiatives.
• Proven track record of providing independent expertise to Manufacturing functions.
• Demonstrated successes in a team environment, such as project teams, PITs etc., and ability to coordinate, influence and guide team members.
• Demonstrated negotiation skills.
• Strong Analytical problem-solving ability and interpersonal skills.
• Advanced PC skills such as Excel, Word, PowerPoint.
• Stakeholder management of multiple decision makers, auditors, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.
• Familiarity with FDA, EU and worldwide GMP regulations/guidelines and System Life Cycle Methodologies
• Working knowledge of current Good Manufacturing Practices, regulatory trends, and the application of these activities to process validation, equipment qualification and computing environments.
• Demonstrated coaching skills
• Demonstrated leadership skills
For a confidential discussion and more information on the role, please contact Eloísa Ruiz on 021 4911066 or email firstname.lastname@example.org