At a Glance
- Tasks: Review analytical data and ensure compliance with quality standards in a pharmaceutical setting.
- Company: Join a leading pharmaceutical company dedicated to quality and innovation.
- Benefits: Attractive salary, health benefits, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on continuous improvement and career advancement.
- Why this job: Make a significant impact on product quality and patient safety in the pharmaceutical industry.
- Qualifications: Degree in Chemistry or related field with extensive experience in Quality Control.
About the role
We are seeking an experienced Senior Quality Control Reviewer to join our pharmaceutical Quality Control team.
You will review analytical data and laboratory records to ensure accuracy, completeness and compliance with approved procedures, specifications, GMP requirements and data integrity principles.
Key responsibilities
- Review raw analytical data for raw materials, packaging materials, in-process samples, finished products and stability studies against approved specifications and standard test procedures.
- Review data generated using HPLC, GC, UV, IR, dissolution apparatus and other analytical instruments.
- Verify calculations, results and supporting documentation, ensuring records are accurate, complete, legible and traceable.
- Check compliance with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), applicable procedures and ALCOA+ data integrity principles.
- Identify and escalate discrepancies, deviations, out-of-specification (OOS), out-of-trend (OOT) and atypical results.
- Review laboratory notebooks, worksheets, electronic records and certificates of analysis, ensuring documentation is ready for audits and inspections.
- Support investigations into OOS, OOT and atypical results by reviewing relevant analytical data and records.
- Review instrument calibration and associated documentation to confirm compliance with approved requirements.
- Review electronic audit trails within Caliber LIMS, Chromeleon and other relevant laboratory software.
- Work closely with laboratory analysts, Quality Assurance, Warehouse and Production teams to resolve queries and support timely completion of data reviews.
- Provide clear feedback to analysts and ensure corrections are appropriately documented in accordance with approved procedures.
Qualifications and experience
- A degree in Chemistry, Pharmaceutical Sciences or a related scientific discipline.
- Typically 8–12 years of relevant experience in pharmaceutical Quality Control, with substantial experience reviewing analytical data.
- Strong working knowledge of HPLC, GC, UV, IR, dissolution testing and associated laboratory documentation.
- Sound understanding of GMP, GLP, ALCOA+ principles and laboratory investigation processes.
- Experience reviewing electronic records and audit trails; familiarity with Caliber LIMS and Chromeleon is desirable.
- Excellent attention to detail, sound analytical judgement and strong communication skills.
- Ability to manage competing priorities and work collaboratively across departments
Senior Quality Control Reviewer in Northampton employer: L M MANUFACTURING LIMITED
L M MANUFACTURING LIMITED offers a dynamic work environment where employees can engage in meaningful quality control processes within the pharmaceutical industry. The company emphasizes compliance with Good Manufacturing Practices (GMP) and provides opportunities for professional growth through rigorous training and adherence to data integrity principles. Employees benefit from a culture of accuracy and accountability, ensuring that their contributions are vital to the company's success.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Quality Control Reviewer in Northampton
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like L M MANUFACTURING LIMITED. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
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Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like L M MANUFACTURING LIMITED.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like L M MANUFACTURING LIMITED. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what L M MANUFACTURING LIMITED is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Senior Quality Control Reviewer in Northampton
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 L M MANUFACTURING LIMITED!
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 L M MANUFACTURING LIMITED 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 L M MANUFACTURING LIMITED!
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 L M MANUFACTURING LIMITED, 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 L M MANUFACTURING LIMITED
✨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 L M MANUFACTURING LIMITED 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 L M MANUFACTURING LIMITED’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.
