At a Glance
- Tasks: Lead quality operations and ensure compliance with GMP standards in pharmaceutical manufacturing.
- Company: Proclinical, a leader in pharmaceutical quality assurance.
- Benefits: Competitive salary, career growth, and opportunities to make a real impact.
- Other info: Dynamic role with opportunities for leadership and collaboration across various teams.
- Why this job: Shape the future of safe, high-quality pharmaceutical products and drive continuous improvement.
- Qualifications: Strong knowledge of GMP, quality systems, and excellent communication skills.
The predicted salary is between 56700 - 69300 £ per year.
Lead the quality agenda, shape compliance excellence, and make a lasting impact on the delivery of safe, high-quality pharmaceutical products.
Proclinical is seeking an Operations Manager GMP Quality to oversee quality operations and assurance activities, ensuring compliance with GMP standards for the manufacture, packaging, testing, storage, and distribution of pharmaceutical products.
This role focuses on maintaining and improving the Quality Management System (QMS), driving continuous improvement initiatives, and collaborating with internal and external stakeholders to enhance compliance and operational efficiency.
Responsibilities
- Foster a culture of quality and compliance across the site, ensuring adherence to GMP, GDP, and industry standards.
- Ensure quality system procedures meet corporate, regulatory, and industry requirements.
- Support site compliance activities, including new GMP implementations and inspection readiness programs.
- Represent and lead Quality Assurance in cross-functional projects and continuous improvement initiatives.
- Oversee QA planning for QC and production activities to enable timely batch review, release, and distribution.
- Perform batch record reviews for site and non-site manufactured products.
- Monitor and report QMS performance metrics and lead Quality Management Review meetings.
- Represent Quality Operations during regulatory inspections, customer audits, and third-party audits.
- Lead the Product Quality Review (PQR) program, including trend analysis and reporting.
- Oversee data integrity processes and ensure compliant data management practices.
- Author, review, and approve SOPs and other quality documentation.
- Support internal and external audit programs.
- Review and approve deviations, complaints, investigations, CAPAs, change controls, and validation documentation.
- Maintain and enhance the QMS to ensure compliance with Gx P and electronic records requirements.
- Deliver GMP and quality systems training, coaching, and mentoring to personnel.
- Drive continuous improvement initiatives to enhance compliance and operational efficiency.
- Provide technical quality expertise and deputize for the Quality Operations Management team as needed.
Key Skills and Requirements
- Strong knowledge of Quality Assurance, Quality Systems, GMP, GDP, and pharmaceutical manufacturing processes.
- In-depth understanding of global GMP regulations and guidelines with the ability to implement and maintain compliance.
- Proven ability to build effective relationships and collaborate across functions, sites, and external partners.
- Strong communication and influencing skills to engage stakeholders at all levels.
- Analytical skills to interpret complex data, identify trends, and present actionable insights.
- Proficiency in Microsoft Office applications (Word, Excel, Power Point).
- Effective leadership skills to drive results, influence decision-making, and motivate teams.
- Competencies include problem-solving, decision-making, time management, critical thinking, and emotional intelligence.
- If you are having difficulty in applying or if you have any questions, please contact
Ingrid Wilson at i. wilson@proclinical. com.
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Operations Manager GMP Quality in Hatfield employer: Proclinical Group
Proclinical Group is an excellent employer, offering a dynamic work culture that fosters collaboration and innovation in the field of diagnostic technologies. Employees benefit from comprehensive training programs, opportunities for professional growth, and the chance to make a meaningful impact on customer satisfaction and business success in the vibrant location of Croydon, UK.
StudySmarter Expert Advice🤫
We think this is how you could land Operations Manager GMP Quality in Hatfield
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We think you need these skills to ace Operations Manager GMP Quality in Hatfield
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 Proclinical Group!
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 Proclinical Group 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 Proclinical Group!
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 Proclinical Group, 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 Proclinical Group
✨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 Proclinical Group 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 Proclinical Group’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.
