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Posted 1 weeks agoQC Release Specialist 2
Uk Hull Manufacturing, United KingdomHybrid
Responsibilities
- Develop and manage relationships with personnel in all applicable functions and levels to ensure the delivery of the highest standards of internal and external customer satisfaction.
Requirements
- Furthermore, this role is responsible in leading the coordination, development, and training of other QC Release Personnel, for compliance against appropriate procedures, along with being considered a subject matter expert in the release controls and process of CMO. Detailed
- requirements To support internal and external audits as required To support the identification and execution of continuous improvement initiatives and projects for the Quality Compliance Release process.
- What will you need to be successful? Typically educated to degree level or has equivalent work
- experience in relevant area. Advanced working knowledge of company products, processes, procedures, and personnel specifically associated to the QC release process At least 5 years’
- experience working within Quality Assurance, preferably within Medical Device / Pharmaceutical Industry.
- Good working understanding of the Medical Device Directive, GxP, ISO 9001, ISO 13485, 21 CFR Part 820.
- Strong analytical and good communication skills are essential together with the ability to manage personal and colleague workload to ensure high standards are maintained.
- Good understanding of the impact of the department on the business.
- Knowledge of the potential for product liability, alleged adverse incidents and potential Field Safety Actions.
- Proficient in Microsoft Systems, specifically Word and Excel, with good written (English) skill required.
- Experience with MS Excel, Word, Outlook, Visio. Advanced understanding of the Smartsolve and SAP user systems, including
- experience in UAT testing and system design requirements. You. Unlimited.
Benefits
- Learn more about our Employee Inclusion Groups on our website (www.smith-nephew.com) Your Future: Generous annual bonus and pension schemes, Save As You Earn share options.
- Work/Life Balance: Flexible vacation and time off, paid holidays and paid volunteering hours, so we can give back to our communities.
- Your Wellbeing: Private health and dental plans, healthcare cash plans, income protection, life assurance and much more.
- Extra Perks: Discounts on gyms and fitness clubs, salary sacrifice bicycle and car schemes and many other employee discounts.
Additional details
- At Smith+Nephew we design and manufacture technology that takes the limits off living.
- The Quality Compliance release team is focused on ensuring that Smith + Nephew complies with key regulatory
- requirements and Smith + Nephew procedures associated to the release of manufactured product.
- This position is responsible for developing, maintaining, and coordinating the compliant release process of finished goods for which Hull are the Legal Manufacturer, ensuring compliance with Company Quality Systems, regulatory and statutory Health & Safety requirements, and Site Safety Policy.
- Responsibilities & Accountabilities To apply high standards of occupational Health & Safety in the workplace to comply with company policy and procedures.
- To perform all activities in compliance with relevant GMP, GDP, ISO 9001, ISO 13485, US FDA 21 CFR Part 820 and any other applicable quality standards or regulations concerning Medicinal Products and Medical Devices To ensure that all Quality Compliance Release external communications are of an acceptable standard to meet customer needs and facilitate improvement where necessary.
- To provide Quality Compliance Release support to CMO and Hull operations to ensure timely closure of quality activities and drive continual improvements.
- To assist and support the internal audit schedule in accordance with the procedure, to ensure compliance and timely close out of improvement actions.
- To assist in the management of the Company’s Quality Archive Store to ensure continued compliance.
- To support Change Control activities ensuring outputs are correctly translated into procedures and are communicated.