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Laboratory Manager - Physical Testing (12 month contract) job in Deeside at ConvaTec

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Laboratory Manager - Physical Testing (12 month contract) at ConvaTec

Laboratory Manager - Physical Testing (12 month contract)

ConvaTec Deeside, Clwyd Full Time
At ConvaTec, our vision is to develop pioneering trusted medical solutions to improve the lives we touch. We are a global medical technology business focused on serving people and care givers in the areas of advanced wound care, ostomy care, continence and critical care and infusion care. We devise, develop and manufacture innovative products and services that support people with deeply personal and challenging medical conditions, helping to improve care for them and giving them greater confidence, freedom and mobility. We are guided by our five core values, that shape the way we work, every day: Improve Care, Deliver Results, Grow Together, Own It and Do What's Right. We are a global Group, with over 9,000 employees and in 2019, our Group generated revenues of over $1.827 billion. To learn more about ConvaTec, please visit www.convatecgroup.com. Every day, our products improve the lives of millions of people around the world. We're hugely proud of this, which is why we're transforming our business to reach millions more. Join us as a Laboratory Manager - Physical Testing and you'll drive progress that really means something. Duties and Responsibilities: To strategically lead and manage the R&D and Sustaining Engineering physical testing programs; ensure the effective planning, co-ordination and execution of all physical testing, and that methods and validation exercises conform to internal procedures, reflect applicable regulations/guidelines and meet industry best practice. Actively manage the NPD and SEG physical testing teams including effective engagement, communication, recruitment, employee performance and development. Responsible for laboratory resource and prioritisation of tasks to ensure deadlines/objectives are met to agreed standard. Responsible for ensuring the equipment calibration and validation schedule is maintained within the physical testing laboratory, and that physical testing equipment is fully qualified (IQ/OQ/PQ) when appropriate. Supports software validation activities for the deployment of equipment software packages. To troubleshoot issues as they occur in the physical testing laboratory and manage deficiencies, incidents and failures with respect to equipment, procedures and test methods within the laboratory. Identify and address non-conformances in relation to physical test methods, procedures and processes; ensure prompt resolution of identified problems via consultation with Quality and provide appropriate recommendations for remedial/corrective actions Ensure suitable technical responses to audits; support CAPA systems where appropriate by addressing any follow-up actions within the agreed timeframe. Accountable for the accurate reporting of all physical test data and technical documentation, including the verification and validation of spreadsheets. Reviews and approves technical data/test results/protocols/reports/ compliance records/laboratory investigations. Provides technical support and guidance to manufacturing sites; supports research and trouble-shooting activities, defines and executes strategies for method validations and transfer of methods when required. To keep abreast of current literature to continuously develop physical test methods and investigate new technologies and alternative ways of working. Provides objective information that is used to adapt project strategy to overcome obstacles that impact timelines and/or quality of the deliverable. Provides appropriate training and development opportunities for staff and ensures scientific expertise is in place to meet business objectives; ensures training records are maintained and updated on a regular basis. Responsible for ensuring physical testing teams always work to safe practices; ensures Risk Assessments, COSHH, Safe Systems of Work are completed to required standards. Work with team members to drive the laboratory forward for continuous improvement. Serves as a central hub for communication of R&D and sustaining engineering project status’, testing updates and issues. Conduct EHS induction and General Laboratory Compliance Awareness training as part of new starter inductions; ensures lab compliance with applicable cGMP regulations and SOP’s. Management of departmental budget. Management of external service providers and suppliers. Take a lead role in laboratory tour presentations. To represent physical testing at interdepartmental and external meetings. Takes responsibility and accountability for all actions undertaken as part of the role. Promotes and develops good working relationships within a multidisciplinary team. Education/Qualifications: Required: Preferably of Degree level in a scientific discipline (microbiology, biology, chemistry or physics) and 7+ years of Med Device/Pharmaceutical Laboratory work experience with increasing responsibilities. Working knowledge and understanding of compliance with FDA and European regulations relating to Quality Systems (ISO13485:2016, ISO9001:2000, FDA 21 CFR part 820) and GMP Guidelines and Regulation. Strong background in physical testing; significant experience, track record and knowledge within physical testing or a laboratory management environment. Possess a flair for problem solving, identifying inefficiencies and implementing solutions. Excellent verbal/written communication skills and the ability to work well in cross functional teams. Microsoft Office skills are essential. Our products make a big difference every day. So will your contribution. The work you do will mean more, because it'll make things better for your team, our business or our customers' lives. It'll inspire you to deliver to your very best. And we'll be right behind you when you do. This is a challenge more worthwhile. This is work that'll move you. ConvaTec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
 
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Job ID: 073f88b795a2