At a Glance
- Tasks: Ensure compliance in biologic drug manufacturing and mentor future Qualified Persons.
- Company: Join Sekisui Diagnostics, a leader in innovative diagnostics solutions.
- Benefits: Competitive salary, comprehensive benefits, and opportunities for professional growth.
- Other info: Diverse and inclusive workplace with a commitment to equal opportunities.
- Why this job: Make a real impact in healthcare by ensuring quality and compliance.
- Qualifications: Must have QP experience in biological drug substance or sterile manufacturing.
The predicted salary is between 49500 - 60500 £ per year.
Sekisui Diagnostics is looking for a Skilled Qualified Person (QP) to join our team in the QA Department in Kent.
As a qualified person, you will be responsible for ensuring all biologic drug substance batches are manufactured, reviewed, certified and released in full compliance with EU/UK GMP requirements and company quality standards. You will provide expert quality and regulatory oversight across manufacturing operations, supporting inspections, audits, quality agreements, training and continuous improvement activities. Working closely with cross-functional teams, you will identify and mitigate compliance risks, maintain the Manufacturing and Import Authorisation (MIA(IMP)), and help drive a culture of quality, regulatory excellence and operational compliance. You will also act as a mentor and subject matter expert, supporting the development of future Qualified Persons while ensuring adherence to MHRA, FDA, ISO and other applicable regulatory requirements.
Responsibilities may include:
- Support maintaining Sekisui's UK Manufacturing and Import Authorisation (MIA(IMP))
- Support hosting regulatory inspections and customer audits
- Support preparing and reviewing GMP contracts and Quality/Technical Agreements
- Maintain up-to-date knowledge of relevant laws, regulations, and guidance, and communicate any changes that may impact Sekisui’s operations.
- Complete Continuous Professional Development (CPD) activities to ensure ongoing compliance with current GMP regulations and standards
- Fulfil all duties in accordance with the Code of Practice for Qualified Persons in the Pharmaceutical Industry
- Provide support and mentorship to a designated Sekisui employee with the objective of developing them toward eventual QP qualification
- Support conducting internal audits and supplier audits
- Delivering cGMP training to personnel
To be successful in the role:
- You must have at least two years’ experience as a Qualified Person (QP) in biological drug substance or sterile manufacturing
- Experience in biologics manufacturing
- Excellent verbal and written communication skills with good attention to detail
- You must be eligible to act as a Qualified Person (QP) under UK legislation and recognized by MHRA through one of the joint Professional Bodies (Royal Pharmaceutical Society, Royal Society of Chemistry, or Royal Society of Biology)
Sekisui Diagnostics offers a competitive compensation and benefits package.
As an equal opportunity employer, Sekisui Diagnostics is committed to a diverse workforce. Employment decisions will be made without discrimination based on race, colour, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, other non-job related characteristics or other prohibited grounds specified in applicable country and local laws.
Sekisui Diagnostics is pleased to consider all qualified applicants for open roles and encourages candidates to apply online. Only those candidates who are selected for further consideration or interviews will be contacted by a member of the company’s internal recruiting team.
Senior QA Specialist ( Qualified Person) in Maidstone employer: United Kingdom
King & Spalding is an exceptional employer, offering a dynamic and supportive work environment in the heart of London. With a strong commitment to employee growth, the firm provides comprehensive benefits including private medical insurance, generous pension contributions, and wellness allowances, ensuring that team members are well-supported both personally and professionally. The collaborative culture fosters innovation and excellence, making it an ideal place for those seeking meaningful and rewarding careers in the legal field.
StudySmarter Expert Advice🤫
We think this is how you could land Senior QA Specialist ( Qualified Person) in Maidstone
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like United Kingdom. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
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 United Kingdom.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like United Kingdom. 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 United Kingdom is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Senior QA Specialist ( Qualified Person) in Maidstone
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 United Kingdom!
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 United Kingdom 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 United Kingdom!
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 United Kingdom, 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 United Kingdom
✨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 United Kingdom 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 United Kingdom’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.
