At a Glance
- Tasks: Manage customer-facing Quality activities and ensure compliance with GMP and regulatory requirements.
- Company: Join Catalent, a global leader in drug development and delivery.
- Benefits: Competitive salary, career growth opportunities, and a dynamic work environment.
- Other info: Be part of a team that values continuous improvement and meaningful work.
- Why this job: Make a real impact by supporting life-saving products and enhancing patient care.
- Qualifications: Experience in pharmaceutical GMP, strong communication skills, and a proactive mindset.
The predicted salary is between 35000 - 45000 £ per year.
The Senior QA Associate, Quality Commercial Operations, plays a key role in managing customer-facing Quality activities, acting as the main point of contact for assigned clients. The position ensures all Quality communications, commitments, and deliverables are handled in a timely, compliant, and professional manner. This role is integral to maintaining strong customer relationships, supporting batch release processes, and ensuring adherence to GMP and regulatory requirements, while driving continuous improvement across Quality systems and operations.
The Role:
- Act as the primary Quality contact for assigned customers, managing all Quality-related communications
- Ensure accurate, timely, and professional responses to customer queries and requests
- Lead and coordinate customer audits, meetings, and visits (onsite and remote)
- Manage deviation notifications, ensuring effective communication and timely closure of actions
- Maintain oversight of all customer-related activities, driving actions through to completion
- Support batch release activities, including pre-release review of batch documentation (EBRs and paper records)
- Assist in the preparation, review, and maintenance of Quality Agreements
- Collaborate with cross-functional teams (Operations, QC, QMS, etc.) to support customer requirements
- Support customer and regulatory inspections as a subject matter expert
- Review and approve QA documentation including SOPs, Change Controls, and PQRs
- Monitor and report on customer metrics, escalating risks or concerns as needed
- Build and maintain strong relationships with both internal stakeholders and customer representatives
- Ensure all activities are conducted in line with GMP, regulatory requirements, and company standards
- Contribute to continuous improvement initiatives, including deviation reduction and right-first-time performance
- Support EHS&S initiatives and promote a strong safety and compliance culture
The Candidate:
- Proven experience within a pharmaceutical GMP environment, with strong knowledge of Quality Assurance
- Demonstrated understanding of Quality Systems and Data Integrity requirements
- Experience managing customer interactions, audits, and Quality-related communications (desirable)
- Strong problem-solving and analytical skills with excellent attention to detail
- Experience reviewing and approving QA documentation (SOPs, Change Controls, PQRs, investigations)
- Experience supporting batch release activities and reviewing batch documentation
- Confident working cross-functionally with Operations, QC, and other departments
- Excellent communication and stakeholder management skills
- Proficient in Microsoft Office and Quality-related electronic systems
- Highly organised with the ability to manage multiple priorities and meet tight deadlines
- Proactive, self-motivated, and able to work independently
- Team player with the ability to influence and build effective working relationships
- Continuous improvement mindset with experience in RCA, CAPA, and lean methodologies
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability.
Senior QA Associate - Quality Commercial Operations in Swindon employer: Catalent
Catalent in Swindon is an exceptional employer, offering a dynamic work environment where safety, quality, and performance are paramount. With a strong focus on employee development and competitive benefits, including bonuses and career advancement opportunities, Catalent fosters a culture of excellence and teamwork that empowers its staff to thrive in their roles.
StudySmarter Expert Advice🤫
We think this is how you could land Senior QA Associate - Quality Commercial Operations in Swindon
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Catalent. 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 Catalent.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Catalent. 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 Catalent is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Senior QA Associate - Quality Commercial Operations in Swindon
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 Catalent!
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 Catalent 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 Catalent!
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 Catalent, 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 Catalent
✨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 Catalent 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 Catalent’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.
