At a Glance
- Tasks: Ensure compliance in the distribution of medicinal products and manage quality assurance.
- Company: Join Dr. Reddy's, a leader in affordable healthcare and innovative treatments.
- Benefits: Be part of a diverse team with opportunities for personal and professional growth.
- Other info: Open to diverse backgrounds; we value unique perspectives and experiences.
- Why this job: Make a real difference in healthcare while developing your career in a dynamic environment.
- Qualifications: Master's degree in relevant field and significant 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 seeking dynamic and energetic individuals ready to inspire and make a difference for their community and every 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 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.
- 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.
- 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 distribution-related deviations.
- 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.
- Falsified Medicines Directive (FMD) Responsibilities
- 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.
- 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.
Qualifications
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.
Additional Information
Key Skills & Competencies
- GMP/GDP expertise.
- Strong auditing and compliance knowledge.
- Analytical decision making.
- Stakeholder management.
- Excellent communication skills.
Qualified Person and Responsible 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 and Responsible Person - UK in Cambridge
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We think you need these skills to ace Qualified Person and Responsible Person - UK in Cambridge
Some tips for your application 🫡
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How to prepare for a job interview at Dr. Reddy's Laboratories
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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.
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✨Know Their Products
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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.
