At a Glance
- Tasks: Manage quality systems, oversee supplier audits, and ensure compliance with GxP requirements.
- Company: Join Indivior, a leader in pharmaceutical innovation and quality assurance.
- Benefits: Competitive salary, diverse workplace, and opportunities for international travel.
- Other info: Dynamic role with excellent career growth and a commitment to diversity.
- Why this job: Make a real impact on quality in the pharmaceutical industry while growing your career.
- Qualifications: 5 years in a GxP environment; strong communication and multitasking skills required.
The predicted salary is between 40000 - 50000 £ per year.
Location: Hull
Position Summary
Embedded in the Quality Assurance team reporting to the Head of QA & QC, this hands-on role supports the management, maintenance and continuous improvement of the quality system at the Indivior Fine Chemical Plant (FCP). The role ensures FCP operations comply with Indivior Global Quality Policies, applicable GxP requirements and the organisation’s quality KPIs and metrics. It also oversees the vendor assurance programme and acts as a business partner to internal and external stakeholders.
Key Responsibilities
- Quality Management: Manage and maintain the QMS, including document control, deviations, CAPA, change control, complaints, OOS/OOT and APQRs. Act as eQMS super-user, support system administration, training, and report site quality KPIs. Identify & implement improvement initiatives, organise monthly quality meetings, support quarterly Quality Management Reviews, and participate in inspections and audits.
- Supplier and Customer Management: Onboard suppliers, maintain approved lists, develop and enforce technical agreements, schedule and conduct supplier audits, support CAPA closure, and manage supplier status communications.
- Good Distribution Practice: Ensure all GDP requirements are met, perform bona fide checks on suppliers and customers, and maintain compliance with GxP.
- Batch Record Review and Release: Review and approve batch records for intermediates and finished products, support training on correct record completion, and manage CoA generation and microbial testing contracts.
- Training: Create and maintain a training matrix for GMP-impacting processes, act as LMS super-user, and ensure training completion.
- Stability and Validation: Manage ongoing stability of APIs, generate protocols and data tables, coordinate analyses, and oversee validation and qualification processes, ensuring documentation is stored in the eDMS.
Minimum Qualifications
- Education: Bachelor of Science preferred but not essential.
- Field of Study: Chemistry, Biology, Pharmacy or similar.
- Experience: Minimum of 5 years in a GxP environment, ideally in API manufacturing.
- Travel: International and domestic travel required for audits, meetings, and conferences.
- Competencies: Highly motivated, flexible delivery of results; strong multi-tasking and prioritisation; excellent communication skills; proven ability to work under pressure; strong GxP knowledge; advanced computer skills (Microsoft platform); Veeva eQMS experience an advantage; experience with controlled drugs.
Preferred Qualifications
- Pharmaceutical/ISO Auditing Course.
Equal Employment Opportunity
Indivior is an Equal Opportunity Employer. We recognize the value of diversity and are committed to providing a workplace free from discrimination.
Quality Specialist- FCP employer: Indivior PLC
Indivior is an exceptional employer, offering a dynamic work environment at the Hull Fine Chemical Plant where quality and compliance are paramount. With a strong commitment to employee development, we provide opportunities for continuous learning and growth within the Quality Assurance team, fostering a culture of collaboration and innovation. Our focus on diversity and inclusion ensures that every voice is valued, making Indivior a rewarding place to build a meaningful career in the pharmaceutical industry.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Specialist- FCP
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We think you need these skills to ace Quality Specialist- FCP
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 Indivior PLC!
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 Indivior PLC 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 Indivior PLC!
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 Indivior PLC, 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 Indivior PLC
✨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 Indivior PLC 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 Indivior PLC’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.
