At a Glance
- Tasks: Lead quality teams to ensure life-saving products meet compliance and are released on time.
- Company: Established pharmaceutical manufacturer known for supplying hard-to-source products.
- Benefits: Competitive salary, career advancement opportunities, and a chance to make a real difference.
- Other info: Dynamic environment with opportunities for professional growth and development.
- Why this job: Join a vital role in ensuring quality for products that impact patients' lives.
- Qualifications: Experience in pharmaceutical formulation and strong knowledge of GMP and MHRA regulations.
The predicted salary is between 56700 - 69300 £ per year.
Sector: Pharmaceuticals
Location: Northeast England
SRG are partnered with an established pharmaceutical manufacturer in the Northeast to find a Head of Operational Quality and Formulation. The company are leaders in the manufacture of Specials, supplying hard-to-source products to the patients who need them. This is a key technical, quality leadership position overseeing the quality and timely release of life-saving products.
The Role
As the head of Operational Quality & Formulation, you will lead the Quality and Formulation teams ensuring the quality & compliance of manufactured Specials products allowing them to reach the patients who need them. Key duties will include:
- Oversight of the product release processes, stability monitoring programmes, and compliance systems across manufacturing operations.
- Acting as Quality Controller on the Manufacturers' Specials License for the site in line with MHRA requirements.
- Overseeing quality teams and processes to ensure timely release of products in compliance with GMP, internal SOPs, and regulatory standards.
- Monitoring key quality release metrics, including batch release timelines, right-first-time rates, and turnaround times for issue resolution.
- Leading monthly performance reviews, contributing to site-level Quality Manager Review forums, and identifying bottlenecks to streamline batch review workflows.
- Managing new product introductions from technical feasibility to production readiness, including working with procurement on starting materials and formulations.
- Designing and overseeing stability programs, owning product lifecycle data, and leading root cause investigations and CAPAs.
- Maintaining compliance with GMP, GDP, and MHRA regulations, supporting audits, and contributing to product quality reviews and change controls.
Requirements
- Registration with the General Pharmaceutical Council (GPhC) is essential.
- Proven experience in a similar position within pharmaceutical formulation, QA, or manufacturing.
- Excellent knowledge of GMP, GDP, and MHRA Specials guidance.
- Experience in deviation investigations, risk assessments, and change control management.
Head Of Operational Quality & Formulation employer: SRG Talent
As a leading pharmaceutical development and manufacturing organisation based in central Scotland, we pride ourselves on fostering a collaborative work culture that prioritises compliance and quality. Our employees benefit from an excellent package that includes enhanced pension, healthcare, and flexible working hours, alongside ample opportunities for professional development and growth within the industry. Join us to be part of a team that values your contributions and supports your career aspirations in a meaningful way.
StudySmarter Expert Advice🤫
We think this is how you could land Head Of Operational Quality & Formulation
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We think you need these skills to ace Head Of Operational Quality & Formulation
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 SRG Talent!
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 SRG Talent 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 SRG Talent!
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 SRG Talent, 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 SRG Talent
✨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 SRG Talent that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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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 SRG Talent’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.
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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.
