At a Glance
- Tasks: Ensure compliance in the distribution of medicinal products and manage quality assurance activities.
- Company: Join Dr. Reddy's, a leader in affordable healthcare and innovative treatments.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Dynamic role with a focus on compliance and community impact.
- Why this job: Make a real difference in healthcare while working with a passionate team.
- Qualifications: Master's degree in relevant field and significant QA experience in pharmaceuticals.
The predicted salary is between 40500 - 49500 £ per year.
- Qualified Person and Responsible Person - UK
- Full-time
- Job Family: Quality
- Sub Job Family: Quality Assurance
- Preferred type of working: On-Premise
- Years of Experience: 3 - 6
- Business unit: EUG
- At Dr. Reddy's "Good Health Can't Wait"
By joining Dr.
Reddy’s, you will contribute to making the breakthroughs of tomorrow a reality today!
From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives.
We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference fortheircommunity andeverycommunity.
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.
We are seeking a Responsible Person (RP) in our Quality Assurance team, to be based in person from our Cambridge, UK office and report to Head of Quality - UK.
You will be accountable for ensuring that all activities related to the importation, storage, transportation, and distribution of medicinal products are conducted in compliance with applicable UK Good Distribution Practice (GDP) requirements, the Human Medicines Regulations 2012 (as amended), and other relevant regulatory obligations.
Responsibilities
- Quality Management System (QMS)
- Implement and maintain the GDP Quality Management System and related documentation
- Hold ultimate responsibility for products manufactured in Europe and stored/transported under the WDA (Wholesale Distribution Authorization)
- Ensure compliance necessary to obtain and maintain the distribution license
- 2. Training and Competency Management
- Implement and maintain GDP training programs for all personnel involved in medicinal product distribution
- Ensure employees receive appropriate GDP training and remain up to date with regulatory requirements
- Inform and train team members on changes in GDP regulations and quality systems
- 3. GDP Operational Oversight
The RP has full responsibility for
- Authorizing all quality-related activities and records
- Coordinating product recalls or supporting recalls initiated by the Marketing Authorization Holder (MAH)
- Managing customer complaints
- Being available 24/7 for transport-related complaints and deviations
- Approving suppliers, customers, and outsourced/subcontracted activities related to distribution
- Managing the self-inspection program to verify GDP compliance and implementation of CAPAs
- Authorizing the handling of returned, rejected, recalled, and falsified medicinal products, including decisions on returning products to saleable stock
- Reporting potential medicinal product shortages to the Dutch national portal
- Ensuring implementation of any additional legal requirements applicable to specific products
- Support implementation of Falsified Medicines Directive requirements
- Ensure robust procedures are in place to identify and manage actual or potential falsified medicines within the supply chain
- Ensure compliance with applicable FMD requirements
- 5. Delegation and Deputy Management
- Maintain records of all delegated responsibilities
- Document what was delegated, to whom, and the duration of delegation where applicable
- Summary of RP Accountabilities
The RP is accountable for
- GDP compliance and maintenance of the distribution licence
- QMS oversight
- Training and competency management
- Deviations, complaints, recalls, and CAPA management
- Supplier, customer, and contractor qualification/approval
- Management of returned, recalled, rejected and falsified products
- Shortage reporting
- FMD compliance
- Documentation of delegated responsibilities
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
- GMP/GDP expertise
- Strong auditing and compliance knowledge
- #J-18808-Ljbffr
Qualified Person and Responsible Person - UK in Cambridge employer: Dr Reddy's Laboratories Limited
Dr. Reddy’s Laboratories Ltd. is an exceptional employer, offering a dynamic and entrepreneurial work culture that empowers employees to make a meaningful impact in the pharmaceutical industry. With a strong focus on employee growth and development, this role as a Commercial Manager provides opportunities for career acceleration and exposure to strategic decision-making within a globally recognised company. Located in the UK & Ireland, employees benefit from competitive compensation, a collaborative environment, and the chance to contribute to innovative healthcare solutions that truly matter.
Contact Details:
Dr Reddy's Laboratories Limited Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Qualified Person and Responsible Person - UK in Cambridge
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Dr Reddy's Laboratories Limited. 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 Dr Reddy's Laboratories Limited.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Dr Reddy's Laboratories Limited. 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 Dr Reddy's Laboratories Limited is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Qualified Person and Responsible 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 Limited!
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 Limited 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 Limited!
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 Limited, 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 Limited
✨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 Limited 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 Limited’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.
