At a Glance
- Tasks: Join our Quality Assurance team to ensure top-notch quality in pharmaceutical production.
- Company: Indivior, a global leader in opioid use disorder treatment.
- Benefits: Competitive salary, career growth, and a chance to make a real difference.
- Other info: Dynamic role with opportunities for international travel and professional development.
- Why this job: Be part of a mission-driven company transforming lives through innovative treatments.
- Qualifications: Experience in GxP environments and strong communication skills required.
The predicted salary is between 40000 - 50000 £ per year.
Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of OUD. Indivior is dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease.
POSITION SUMMARY: Embedded in the Quality Assurance team reporting to the Head of QA and QC, this position is a hands-on role tasked with supporting management, maintenance and continuous improvement of the quality system at the Indivior Fine Chemical Plant (FCP). This role has responsibilities in assuring FCP operations are in compliance with Indivior Global Quality Policies, applicable GxP requirements and the organisation’s expectations with respect to Quality owned KPIs and metrics.
ESSENTIAL FUNCTIONS: The responsibilities of this job include, but are not limited to, the following:
- Quality Management: Manage and maintain the QMS to assure document control activities, deviations, CAPA, change control, complaints, OOS/OOT and APQRs are completed in an effective and timely manner to support consistent compliance to KPI targets, GxP requirements and Indivior policies and procedures.
- Supplier and Customer Management: Onboard FCP suppliers and service providers in accordance with Indivior policies and procedures. Maintain the FCP Approved Suppliers lists. Implement and maintain Technical Agreements with suppliers and service providers, where required.
- Good Distribution Practice: Ensure that all GDP requirements are met according to Indivior policies and procedures and applicable GxP requirements.
- Batch Record Review and Release: Review and approve production batch records for intermediates and finished product to assure manufacturing schedules are maintained and supported.
- Training: Generate and maintain training matrix for GMP impacting processes and procedures, support creation and maintenance of role specific curricula in the LMS.
- Validation and Qualification: Manage the validation and qualification process (including cleaning) at FCP, ensuring producers and templates are maintained in the eDMS.
MINIMUM QUALIFICATIONS: Education: Bachelor of Science degree is preferred but not essential. Experience: Minimum of 5 years in a GxP environment, ideally but not necessarily in the API manufacturing area. Travel: International and domestic travel will be required for audit, meetings, conferences etc.
COMPETENCIES/CONDUCT: In addition to the minimum qualifications, the employee will demonstrate: Highly motivated and flexible approach to results delivery. Solid competencies to manage multiple tasks and priorities within a fast-paced, entrepreneurial environment. Excellent communication skills - presentation, written and oral. Proven ability to work under pressure without compromising deliverables. Strong GxP knowledge predominantly in GMP environments. Strong computer skills including Microsoft platform. Knowledge of Veeva eQMS an advantage.
PREFERRED QUALIFICATIONS: Pharmaceutical/ISO Auditing Course.
GUIDING PRINCIPLES: Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.
EQUAL EMPLOYMENT OPPORTUNITY: EOE/Minorities/Females/Vet/Disabled.
Quality Specialist- FCP employer: Indivior
Indivior is an exceptional employer, offering a dynamic work environment in Hull that fosters innovation and collaboration in the pharmaceutical industry. With a strong commitment to employee growth, Indivior provides comprehensive training and development opportunities, ensuring that team members can thrive while contributing to meaningful work that transforms lives. The inclusive culture and focus on quality assurance make it an ideal place for professionals seeking to make a real impact in the fight against opioid use disorder.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Specialist- FCP
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Indivior. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
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 Indivior.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Indivior. 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 Indivior is looking for. A tailored application can really make you stand out!
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!
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 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!
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, 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
✨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 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’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.
