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- Tasks: Join our team as a Quality Specialist, ensuring top-notch quality in pharmaceutical products.
- Company: Be part of a well-established pharmaceutical company known for its diverse customer base and growth potential.
- Benefits: Enjoy a collaborative work environment with opportunities for professional development and corporate perks.
- Why this job: Make a real impact on healthcare by promoting quality compliance and driving positive change.
- Qualifications: Must have a scientific degree and prior experience in a quality role within the pharmaceutical industry.
- Other info: Ideal for team players who thrive in dynamic environments and are passionate about quality assurance.
The predicted salary is between 36000 - 60000 £ per year.
We are recruiting for a Quality Specialist to join a growing Pharmaceutical business and play a key role in the company's continued growth.
About the business:
This organisation is well established, has a diverse customer base, and is well geared for growth in the coming years. The business supplies a range of pharmaceutical products into multiple segments of the healthcare sector and has a strong reputation as one of the leaders within this field. They have a diverse and inclusive team, and you will get the opportunity to work alongside a talented Quality team to play a key role in driving a positive quality culture.
About the Quality Specialist role:
The Quality Specialist will be responsible for administration and database control within the department. You will provide administrative support to customers and colleagues, whilst being responsible for maintaining databases such as error recording, enquiries, final release, CAPA, and QMS. The scope will also include overseeing the quality of all products manufactured or sourced by the company and ensuring adherence to GMP, GDP, documented procedures, and work instructions.
Key Responsibilities:
- Promoting Quality Compliance (GMP) within the site and comply with company policies.
- Review Finished Batch Record and GMP Release for final QP Release.
- Oversee and input to QMS related Change Control, Non-conformance, and CAPA's.
- Develop, enhance, and update the Quality Management System (QMS) activities associated with the release of product, integrating as appropriate into central activities.
- Ensure appropriate maintenance of filing of Quality related documents, including Deviations and CAPA’s.
- Maintain all QA databases which include but are not limited to QMS, master list, quality metrics, errors, daily orders, product enquiries, and documents.
- Support in product enquiries ensuring timely responses.
- Control and maintenance of Quality documentation, including generating, reviewing, issuing SOPs, forms, and BMRs.
- Liaise with suppliers to obtain documents needed for Quality Approval such as leaflets, cartons, and licenses.
- Documentation writing including reports, recording deviations, non-compliances, and other quality related forms.
- Coordinate and manage to resolve customer complaints, recalls, change controls, ensuring proper root cause analysis and prompt responses/resolution.
Minimum Requirements:
The successful candidate for the Quality Specialist role will have the following background:
- Prior experience working in a Quality function, as a Quality Specialist / Quality Officer within the Pharmaceutical industry.
- A Scientific Degree Qualified, along with credible industry relevant training.
- Batch release experience is highly desirable.
- Good understanding of Good Manufacturing Practice (GMP).
- A team player, who enjoys working with others to drive positive change within a complex environment.
Quality Specialist - Pharmaceutical employer: Alejandria S.A.
Contact Detail:
Alejandria S.A. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Specialist - Pharmaceutical
✨Tip Number 1
Familiarise yourself with Good Manufacturing Practice (GMP) guidelines, as this is crucial for the Quality Specialist role. Understanding these regulations will not only help you in interviews but also demonstrate your commitment to quality compliance.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those working in quality assurance. Attend industry events or join relevant online forums to connect with potential colleagues and learn more about the company culture at StudySmarter.
✨Tip Number 3
Prepare to discuss your experience with database management and quality documentation during the interview. Highlight specific examples of how you've maintained or improved quality systems in previous roles to showcase your expertise.
✨Tip Number 4
Research StudySmarter's current projects and initiatives related to quality assurance. Being knowledgeable about our work will allow you to ask insightful questions during the interview, showing your genuine interest in the position and the company.
We think you need these skills to ace Quality Specialist - Pharmaceutical
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality assurance within the pharmaceutical industry. Emphasise any specific roles or responsibilities that align with the Quality Specialist position, such as batch release experience or knowledge of GMP.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality compliance and your understanding of the pharmaceutical sector. Mention how your background and skills make you a perfect fit for the role and the company's goals.
Highlight Relevant Skills: In your application, focus on key skills that are essential for the Quality Specialist role, such as database management, documentation writing, and customer complaint resolution. Use specific examples to demonstrate these skills in action.
Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. A polished application reflects your attention to detail, which is crucial in a quality-focused role.
How to prepare for a job interview at Alejandria S.A.
✨Know Your GMP
Make sure you have a solid understanding of Good Manufacturing Practice (GMP) and how it applies to the role. Be prepared to discuss specific examples from your past experience where you ensured compliance with GMP standards.
✨Familiarise Yourself with QMS
Since the role involves maintaining and enhancing the Quality Management System (QMS), brush up on your knowledge of QMS processes. Be ready to explain how you've contributed to similar systems in previous positions.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills, especially regarding quality issues like non-conformance or CAPA. Think of examples where you successfully resolved such issues and be ready to share them.
✨Show Your Team Spirit
This role requires collaboration with various teams. Highlight your experience working in diverse teams and how you’ve driven positive change. Share anecdotes that demonstrate your ability to work well with others in a complex environment.
