At a Glance
- Tasks: Ensure compliance and quality in vaccine production while liaising with regulatory authorities.
- Company: Valneva, a leading specialty vaccine company dedicated to global public health.
- Benefits: Stock options, gym membership, LinkedIn Learning, and more perks to support your well-being.
- Other info: Flexible full-time and part-time roles available with excellent career growth opportunities.
- Why this job: Join a mission-driven team making a real difference in global health through innovative vaccines.
- Qualifications: Degree level education and experience in cGMP for biopharmaceuticals required.
The predicted salary is between 36000 - 60000 £ per year.
Overview
Valneva Livingston, Scotland, United Kingdom
We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We have leveraged our expertise and capabilities to commercialize vaccines and advance a broad range of candidates, with operations in multiple countries. We are committed to making a positive impact on global public health.
We are currently recruiting for our new QP, and applications from both full time and part-time QP\'s will be considered.
Valneva\'s mission is to help protect the lives of people around the world through the discovery, development, and commercialization of innovative vaccines against infectious diseases, in compliance with current GxP regulation. The incumbent of the position needs to support the company\\\'s vision and mission by acting with integrity, in a compliant, respectful, customer centered, accountable and compassionate way in order to support achieving the company\\\'s strategic goals.
Responsibilities
- To perform the legal and routine duties of a QP with respect to the review, approval and certification of licensed and investigational products; as defined in article 51 of Directive 2001/83/EC (as amended by Directive 2004/27/EC) and described in Annex 16 of the EU Guide to GMP
- To represent the company to external authorities on liaison with MHRA, FDA, EMEA CAs and OMCLs on; product defect reporting, recall and Inspection related matters (all interactions must be aligned with Regulatory Affairs)
- To advise the Director of Quality Operations on any matters arising which impact on supplier or service provider status or the import of bulk product into EU, or release of final product for use in the UK/EU and its export from the EU
- To manage the batch disposition process, comprising batch document review and approval and batch certification file compilation. Make quality assessments on released products subject to temperature excursions and communicate to customers
- To ensure the systems and processes for the management of Product Technical Complaints and Product Recalls are being conducted in accordance with the licensed risk management and pharmacovigilance systems
- To act as Livingston site representative for Product Safety Review Board. Escalation of relevant issues to and from committee meetings/Global Quality Focus Groups
- To assist with the preparation, review and approval of technical / quality agreements for suppliers and service providers
- To prepare and / or review and approve Quality Investigations which impact on cGMP related activities and batch disposition decisions
- In compliance with UK, EU/FDA quality rules and guidelines, to manage the resources, procedures and reports necessary to ensure effective execution of the external supplier audit program to a defined schedule, in conjunction with Global Quality Assurance
- In conjunction with QA, to perform external audits and internal audits as deemed necessary (e.g. for-cause investigations and unscheduled cGMP audits). Provide support to management during third-party audits
- To independently verify the audit reports and programme compliance, escalate any adverse trends or major non-conformances reported and make recommendations on appropriate corrective action in support of the approval / rejection of suppliers or products
- To identify areas of improvement for internal and Global Quality Systems/procedures and to provide support with the implementation of such improvements
- In conjunction with the concerned departmental personnel, develop suitable reporting mechanisms (e.g. key quality indicators) which provide assurance of effective quality oversight of both internal and externally contracted manufacturing and testing activities
- To keep up to date with current guidelines and regulatory requirements (e.g. Pharmacopoeial changes) in respect of quality requirements
- Implement and maintain Standard Operating Procedures, as required
- To undertake any other duties as requested by the line manager in accordance with company requirements
Requirements
- Degree level education or equivalent experience
- Eligible QP (UK qualified, under the Permanent Provisions)
- Relevant experience of UK, EU and FDA cGMP requirements for the manufacturing and testing of biopharmaceutical products in a commercial environment
- Good understanding and working knowledge of the Pharmaceutical Industry
Benefits
- Stock Options
- Employee Assistance Programme
- Gym membership OR fitness allowance
- LinkedIn Learning
- EV Salary Sacrifice scheme
- Many others included
Qualified Person in Livingston employer: Valneva
Valneva is an exceptional employer located in Livingston, Scotland, dedicated to advancing global public health through innovative vaccine development. With a strong commitment to employee well-being, we offer a range of benefits including stock options, gym memberships, and professional development opportunities through LinkedIn Learning. Our collaborative work culture fosters integrity and accountability, ensuring that every team member can contribute meaningfully to our mission while enjoying a supportive environment for personal and professional growth.
StudySmarter Expert Advice🤫
We think this is how you could land Qualified Person in Livingston
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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 Valneva.
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We think you need these skills to ace Qualified Person in Livingston
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 Valneva!
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 Valneva 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 Valneva!
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 Valneva, 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 Valneva
✨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 Valneva 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 Valneva’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.
