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- Tasks: Lead quality management and ensure compliance in a growing pharmaceutical company.
- Company: Join a dynamic pharmaceutical manufacturer based in St Albans, Hertfordshire.
- Benefits: On-site role with opportunities for professional growth and leadership experience.
- Why this job: Make a real impact on product quality and regulatory compliance in the healthcare sector.
- Qualifications: 5+ years in Quality Assurance with leadership experience in the pharmaceutical industry required.
- Other info: This role involves hosting inspections and certifying licensed medicines.
The predicted salary is between 43200 - 72000 £ per year.
Exciting opportunity: Head of Quality/ Qualified Person for a growing pharmaceutical manufacturer.
If you are a seasoned Quality professional, based in or around St Albans, Hertfordshire, with leadership experience in the pharmaceutical industry, this role might be for you! This role will be on-site 5 days per week.
Your Responsibilities:
- Responsible to oversee and continually review the quality management system to ensure that improvements are identified and that any deficiencies are addressed at their root cause and appropriate procedures are developed and fully implemented.
- Verify and ensure that the products are manufactured, packed and tested to the requirements of registered MA.
- Responsible to review the third-party audit reports for APIs and packaging materials. Responsible for the review of annual product quality reviews.
- Ensuring complaints and adverse incidents are accurately recorded and addressed in a thorough and timely manner in accordance with the company QMS.
- Responsible for hosting MHRA inspections, writing the response reports and to liaise with the Medicines Inspectorate to ensure that the Company conforms to the requirements of GMP and the Manufacturing and Product Licenses.
- Develop, manage and maintain the company's device family technical files and product specific design dossiers ensuring compliance with the relevant regulations.
- Remain up to date with impending changes and developments regarding regulatory and compliance requirements as well as evolving best practices in compliance control.
- To approve specifications, sampling instructions, test methods, and QC procedures, including amendments.
- To approve and monitor suppliers of raw materials and packaging components.
Additional responsibilities for Head of Quality as QP:
- Responsible as named QP to coordinate the preparation and hosting of MHRA and customer inspections.
- To act as 'Qualified Person' in approving Finished Product for release onto the marketplace.
- Performing QP batch certification of licensed medicines (per applicable regulations) and providing QP support as required for Quality issues.
Your experince, skills and qualifications:
- A bachelors or associate degree.
- A minimum of 5 years experince in the Quality Assurance at a manufacturing site
- Previous experince in a leadership role.
- Extensive Pharmaceutical Industry experince with hands on experince in development/quality in a GxP environment.
If this sounds like the perfect opportunity for you or someone you know, please share your CV at !
Head of Quality employer: X4 Life Sciences
Contact Detail:
X4 Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Head of Quality
✨Tip Number 1
Make sure to highlight your leadership experience in the pharmaceutical industry during networking events or informal meetups. Connecting with professionals in your area can lead to valuable insights and potential referrals.
✨Tip Number 2
Stay updated on the latest regulatory changes and best practices in quality management systems. This knowledge will not only help you in interviews but also demonstrate your commitment to continuous improvement in the field.
✨Tip Number 3
Consider reaching out to current or former employees of the company to gain insights into their culture and expectations. This can give you an edge in understanding what they value in a Head of Quality.
✨Tip Number 4
Prepare to discuss specific examples from your past experiences where you successfully addressed quality deficiencies or led a team through regulatory inspections. Concrete examples will make your candidacy more compelling.
We think you need these skills to ace Head of Quality
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in Quality Assurance within the pharmaceutical industry. Emphasize your leadership roles and any specific achievements that demonstrate your ability to oversee quality management systems.
Craft a Strong Cover Letter: Write a cover letter that clearly outlines your passion for quality management and your understanding of regulatory requirements. Mention your experience with MHRA inspections and your role as a Qualified Person, as these are crucial for the position.
Highlight Relevant Skills: In your application, focus on skills that are essential for the Head of Quality role, such as problem-solving, attention to detail, and knowledge of GxP environments. Provide examples of how you've successfully implemented quality improvements in previous roles.
Showcase Continuous Learning: Demonstrate your commitment to staying updated with industry changes and best practices. Mention any relevant training, certifications, or professional development activities that showcase your dedication to quality assurance.
How to prepare for a job interview at X4 Life Sciences
✨Showcase Your Leadership Experience
Since the role requires leadership experience, be prepared to discuss specific examples of how you've successfully led teams in the pharmaceutical industry. Highlight your ability to manage quality systems and drive improvements.
✨Demonstrate Regulatory Knowledge
Familiarize yourself with GMP regulations and the requirements for hosting MHRA inspections. Be ready to discuss how you have ensured compliance in previous roles and how you stay updated on regulatory changes.
✨Prepare for Technical Questions
Expect questions related to quality management systems, product quality reviews, and batch certification processes. Brush up on your technical knowledge and be ready to explain your approach to maintaining high-quality standards.
✨Discuss Problem-Solving Skills
Be prepared to share examples of how you've identified root causes of quality issues and implemented effective solutions. This will demonstrate your analytical skills and commitment to continuous improvement.
