At a Glance
- Tasks: Ensure quality compliance for medical products and lead a dynamic QC team.
- Company: Join Smith+Nephew, a leader in innovative medical technology.
- Benefits: Enjoy flexible working, generous bonuses, and health perks.
- Other info: Be part of a community that values inclusion and personal growth.
- Why this job: Make a real impact on healthcare while developing your skills.
- Qualifications: Degree or equivalent experience in Quality Assurance, preferably in medical devices.
The predicted salary is between 40000 - 50000 £ per year.
Life Unlimited. 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.
Furthermore, this role is responsible for 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 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.
- To collate, interpret and report data from multiple sources to support business reporting activities including the generation of Certificates of Analysis.
- To review goods returned for applicable disposition according to local procedural requirements.
- To input and manage data within existing Quality System databases.
- To present Quality system processes as SME and provide data to external regulatory bodies and senior management as required.
- To ensure efficient and effective Quality Compliance Release processes are operating site wide through the development and implementation of procedures, training, and guidance.
- To lead and coordinate NCs and Corrective Action & Preventative Action (CAPA) relating to function.
- To escalate adverse trends and ensure all specified actions are closed in a timely manner within the Quality Systems team.
- To provide Quality Compliance support to Operations / Project Teams to ensure that changes are controlled within defined Quality Systems and meet customer needs.
- To assist as required in the creation and management of departmental measures which monitor section performance and drive continuous improvement.
- To assist, where necessary, in any potential or actual Field Safety Corrective Actions.
- To manage workload effectively to achieve personal and departmental objectives, and support other QC personnel with theirs.
- To provide an efficient and timely service to meet business requirements.
- To analyse data and establish conclusions based on available information.
- To lead, mentor and support the training and development of Quality Compliance Release personnel accordingly.
- To support the establishment and maintenance of appropriate documentation to support Quality Compliance Release requirements in alignment with global and local procedural 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.
- To 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.
- 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.
QC Release Specialist 2 employer: Smith & Nephew
At Smith+Nephew, we pride ourselves on being an exceptional employer, offering a vibrant work culture that champions inclusion and belonging. Our commitment to employee growth is evident through tailored mentorship and training opportunities, alongside generous benefits such as flexible working arrangements, private health plans, and a strong focus on work-life balance. Located in Hull, our team thrives in an environment that not only prioritises compliance and quality but also fosters community engagement and personal well-being.
StudySmarter Expert Advice🤫
We think this is how you could land QC Release Specialist 2
✨Unlock Networking Opportunities
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Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Smith & Nephew.
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If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Smith & Nephew. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Smith & Nephew is looking for. A tailored application can really make you stand out!
We think you need these skills to ace QC Release Specialist 2
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Smith & Nephew!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Smith & Nephew that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Smith & Nephew!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Smith & Nephew, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Smith & Nephew
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Smith & Nephew that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Smith & Nephew’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
