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- Tasks: Oversee batch release processes and ensure compliance with regulatory standards.
- Company: Join a leading European specialty pharmaceutical company making a difference in healthcare.
- Benefits: Enjoy a competitive salary, bonus, car allowance, and flexible work options.
- Other info: This role requires full right to work in the UK and is primarily on-site.
- Why this job: Be part of a quality-driven culture and collaborate with diverse teams in a fast-paced environment.
- Qualifications: Must have at least 2 years as a Qualified Person in the pharmaceutical industry.
The predicted salary is between 54000 - 90000 £ per year.
Job Type: Full-time permanent position
Location: East London/Essex, UK – 4x a week on site, 1-day WFH
Remuneration: Up to £90,000 + 10% Bonus + Car Allowance
My client is a leading European specialty pharmaceutical company that is seeking an experienced Qualified Person. This pivotal role involves supporting the batch release of products manufactured on the business's site and driving a quality culture across the organisation.
Key Responsibilities:
- Oversee batch release processes to ensure compliance with regulatory standards.
- Provide QA support to manufacturing, packaging and supply chain, and to all business areas.
- Provide advice, guidance, support and mentoring to all staff with the site in matters relating to the safety, quality and efficacy of the manufacturing and distribution of medicinal products and investigational medical products.
- Review, assess and management of quality risk.
- Collaborate with cross-functional teams to maintain high-quality standards.
- Implement and promote a strong quality culture within the organization.
- Ensure product is made in accordance with manufacturing licenses and equivalent marketing authorizations.
- Assure product, process and facilities comply with national and global regulatory requirements in alignment to the site policies.
- Provide quality oversight of all activities on site and of subcontractors.
- Actively participate in/chair Site Quality Review Team Meetings.
- Ensure any significant quality or compliance issues are escalated to senior management.
- Review and approve quality documentation.
Qualifications:
- Proven experience as a Qualified Person (Minimum 2 years as a QP) in the pharmaceutical industry.
- In-depth knowledge of regulatory requirements and quality assurance.
- Strong analytical and problem-solving skills.
- Registered UK/EU Qualified person with relevant experience in the pharmaceutical industry.
- Passionate leader able to drive a culture with Quality at the centre of decision making.
- Enjoy a fast-paced environment and autonomy.
- Strong GMP background and related decision-making skills.
- Experience working with solid dosage forms including tablet formations, capsules and non-sterile liquids and suspensions.
- Extensive QMS management experience.
- Previous experience working on-site as a QP.
This role does not offer sponsorship, so you MUST have the full right to work in the UK.
For more information please contact lucy.kirkaldy@cpl.com
Qualified Person (QP) employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Qualified Person (QP)
✨Tip Number 1
Network with professionals in the pharmaceutical industry, especially those who are already working as Qualified Persons. Attend industry events or webinars to connect with potential colleagues and learn about the latest trends and requirements in quality assurance.
✨Tip Number 2
Familiarise yourself with the specific regulatory standards and quality assurance practices relevant to the role of a QP. This will not only enhance your knowledge but also demonstrate your commitment to maintaining high-quality standards during interviews.
✨Tip Number 3
Prepare to discuss your previous experiences in detail, particularly any challenges you faced as a QP and how you overcame them. Highlighting your problem-solving skills and ability to drive a quality culture will set you apart from other candidates.
✨Tip Number 4
Research the company thoroughly, including their products, values, and recent news. Tailoring your conversation to align with their mission and demonstrating your enthusiasm for contributing to their quality culture can make a strong impression during the interview process.
We think you need these skills to ace Qualified Person (QP)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience as a Qualified Person, particularly in the pharmaceutical industry. Emphasise your knowledge of regulatory requirements and quality assurance, as well as any specific experience with sterile and non-sterile products.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality assurance and your leadership skills. Mention specific examples of how you've driven a quality culture in previous roles and how you can contribute to the company's goals.
Highlight Relevant Experience: In your application, clearly outline your relevant experience, especially your time spent working on-site as a QP. Include details about your involvement in batch release processes and your ability to collaborate with cross-functional teams.
Proofread Your Application: Before submitting, carefully proofread your application for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in the role of a Qualified Person.
How to prepare for a job interview at Cpl Life Sciences
✨Know Your Regulatory Standards
As a Qualified Person, it's crucial to have a solid understanding of regulatory requirements. Brush up on the latest guidelines and be prepared to discuss how you ensure compliance in your previous roles.
✨Demonstrate Your Quality Culture Leadership
This role requires someone who can drive a quality culture. Be ready to share examples of how you've fostered a quality-first mindset in your team or organisation, and how you plan to implement this in the new role.
✨Showcase Your Problem-Solving Skills
Expect questions that assess your analytical abilities. Prepare to discuss specific challenges you've faced in batch release processes and how you resolved them, highlighting your decision-making skills.
✨Engage with Cross-Functional Collaboration
Collaboration is key in this position. Think of instances where you've worked with different teams to maintain high-quality standards and be ready to explain how you facilitated effective communication and teamwork.