At a Glance
- Tasks: Ensure quality and compliance in medicinal product batches at Dr. Reddy's.
- Company: Join a leading pharmaceutical company dedicated to health and innovation.
- Benefits: Competitive salary, diverse workplace, and opportunities for professional growth.
- Other info: Be part of a culture that values diversity, equity, and inclusion.
- Why this job: Make a real impact on healthcare while working in a dynamic team.
- Qualifications: Master's degree in relevant field and experience in Quality Assurance.
The predicted salary is between 40500 - 49500 £ per year.
At Dr. Reddy’s, you will contribute to making the breakthroughs of tomorrow a reality today! We are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire and make a difference in their community.
Diversity, Equity & Inclusion
At Dr. Reddy’s, we are deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team. We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background.
Job Description
We are seeking a Qualified Person in our Quality Assurance team to be based in person from our Cambridge, UK office and report to Head, Quality - UK. You will be responsible for certification and release of medicinal product batches. You will support Quality Management Systems and compliance activities.
Responsibilities
- Support Quality Assurance in efficient functioning and implementation of all Quality plans at site.
- Ensure that all activities are performed in accordance with regulatory and legal requirements and in compliance with current GMP, GDP, company SOPs and Health and safety policies/SOPs.
- Create, implement, monitor, review and continuously improve cGMPs, Quality Management Systems (QMS) and procedures as assigned/required by Head of Quality.
- Conduct External Audit system, liaising with clients and auditors, ensuring audits are planned and performed within given timelines.
- Review audit reports for completion including audit close out, following up on audit response plan, ensuring all actions are completed within given timelines.
- Provide QP support in the evaluation of investigation and documentation pertaining to quality of products or processes.
- Review and decision making on the fate of change controls, deviations, complaints, CAPAs related to vendors and service providers.
- Review and approval of periodic product quality review and identify any risk associated with product/facility during the review period.
- Undertake the duties of a Qualified Person in accordance with EU directives 2001/83/EC and 2001/82/EC.
- Motivate, coach and mentor Quality team members and provide direction and guidance on quality and GMP issues.
- Work with all members of staff and senior management to develop, improve and maintain the positive quality culture within Dr. Reddy’s, Cambridge.
- Ensure the cGMP compliance and Quality systems in place at Dr. Reddy’s, Cambridge are efficient, effective and enable the organization to achieve its Quality, Regulatory and Business objectives.
- Work as a Responsible Person (import) (RPi) as described in regulations 45AA and 45AB of the Human Medicines Regulations 2012 (as amended).
- Assist with the activities required to carry out the closure of the Beverley site, and transfer of the QMS activity to the Cambridge site.
- Assist with the activities required to add Biologics as a permitted product category to the Cambridge site MIA.
- Undertake any other duties within Quality, which may be requested by the Head of Quality, for which training and/or an explanation has been provided and understood.
Additional Information
Education & Experience
- Master Degree in Pharmacy, Pharmaceutical Chemistry, Life Sciences or related field.
- Eligible to act as a Qualified Person under applicable UK/EU regulations.
- Significant Quality Assurance experience in pharmaceutical industry.
Key Skills & Competencies
- GMP/GDP expertise.
- Strong auditing and compliance knowledge.
- Analytical decision making.
- Stakeholder management.
- Excellent communication skills.
Qualified Person - UK in Cambridge employer: Dr. Reddy's Laboratories
Dr. Reddy’s Laboratories Ltd. is an exceptional employer that fosters a collaborative and innovative work culture, empowering employees to take ownership of their roles while driving strategic initiatives in the UK & Ireland market. With a strong focus on professional development, employees benefit from extensive growth opportunities in revenue management and strategic decision-making, all within a supportive environment that values teamwork and excellence.
StudySmarter Expert Advice🤫
We think this is how you could land Qualified Person - UK in Cambridge
✨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 Dr. Reddy's Laboratories.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Dr. Reddy's Laboratories. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
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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 Dr. Reddy's Laboratories is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Qualified Person - UK in Cambridge
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 Dr. Reddy's Laboratories!
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 Dr. Reddy's Laboratories 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 Dr. Reddy's Laboratories!
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 Dr. Reddy's Laboratories, 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 Dr. Reddy's Laboratories
✨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 Dr. Reddy's Laboratories 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 Dr. Reddy's Laboratories’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.
