At a Glance
- Tasks: Ensure quality assurance for life-changing medicines and support clinical trials.
- Company: Join Jazz Pharmaceuticals, a global leader in biopharma innovation.
- Benefits: Enjoy medical, dental, vision insurance, retirement plans, and flexible vacation.
- Other info: Remote position with opportunities for professional growth in a dynamic environment.
- Why this job: Make a real impact on patients' lives through innovative pharmaceutical development.
- Qualifications: Bachelor's degree in chemistry or biology; experience in quality assurance and vendor auditing.
The predicted salary is between 50000 - 65000 £ per year.
Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience.
This position is part of the PDQA group with the Drug Discovery and Pharmaceutical Development Quality team at Jazz Pharmaceuticals. The position supports the Pharmaceutical Development and Manufacturing Sciences Team (PDMS) in contract manufacturing operations and development of Investigational Medicinal Products (IMPs) and ensures that suitable IMP is provided to the Clinical Trials Supply Management (CTSM) Team for use in clinical trials.
Responsibilities:
- Represent PDQA on CMC matrix teams for Jazz development Projects
- Monitor the operations at the Contract Manufacturer of IMPs, perform batch review, review product complaints, deviations, change controls and product related investigations (OOS investigations, deviations and CAPAs).
- Act as lead auditor in third party vendor audits for IMPs, to include: GMP contract manufacturing, analytical testing and storage facilities when required to ensure compliance with Jazz requirements and country specific regulations.
- Managing the product stability programme for IMPs
- Develop and write SOPs & controlled documents as required.
- Generate and maintain Product Specification Files (PSFs)
- Review and approval of product labelling
- Build authentic relationships and participate in meetings, as required, with suppliers and contract manufacturers and maintain all product-related, Quality Technical Agreements (QTA’s), QP Agreements and QP Declarations.
- Operating supplier management process to include qualification, re-qualification and discontinuation of contractors.
- Participate in continuous improvement projects utilising Operational Excellence programs.
- Developing and maintaining Quality Systems and ensuring that all operations are fully in compliance with current international standards for cGMP.
- Support validation activities.
- Supporting CTSM with on time Quality review and approvals to ensure timely supply of clinical material to trial sites.
Other Responsibilities:
- Work directly with other key Jazz Pharmaceutical departments to ensure compliance and productive working relationships.
- Work closely with other members of Technical Operations organization to ensure delivery of key project objectives and timelines
- Contribute to management of the supplier approval program through audit participation and GxP compliance oversight
- Assist with troubleshooting quality issues at Partner’s or vendor’s site or associated with technology transfer, when required.
- Maintain appropriate Quality Technical Agreements with all GxP vendors
- Supporting regulatory submissions
Personal Competencies:
- Bachelor's degree in chemistry, biology or a related discipline
- Experience working in finished product pharmaceutical/ biologics, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas
- Experience with third party vendor auditing, complaint handling and change control
- Thorough understanding of quality systems and GMP/GDP
- Very good oral and written communication skills
- Interpersonal skills and professional skills to interact at all levels including senior executives, contractors, and colleagues
- Experience working with contract manufacturing
- Experience interfacing with regulatory bodies or supporting regulatory submissions
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation.
Senior QA Specialist, Pharmaceutical Development Quality Assurance (Maternity Leave Cover - Remote / Home Based) in Lisburn employer: Jazz Pharmaceuticals
Jazz Pharmaceuticals is an exceptional employer that prioritises innovation and patient care, offering a collaborative and inclusive work culture. Employees benefit from flexible remote working arrangements, comprehensive health insurance, and opportunities for professional growth within a global biopharma environment dedicated to developing life-changing medicines. With a commitment to employee well-being and continuous improvement, Jazz fosters a supportive atmosphere where every team member can thrive and contribute to meaningful advancements in healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Senior QA Specialist, Pharmaceutical Development Quality Assurance (Maternity Leave Cover - Remote / Home Based) in Lisburn
✨Get Familiar with Temporary Roles in Pharma
Temporary positions in the pharmaceutical industry often arise during specific periods, like product launches or seasonal hiring sprints. Keep an eye on timelines and be proactive in reaching out to companies, especially around these busy times!
✨Join Pharma Networking Events
Participate in local and virtual pharmaceutical networking events or job fairs. This is a fantastic way to get in front of hiring managers and learn more about temporary opportunities directly from those in the know.
✨Leverage Your University Career Services
If you’re a student or recent grad, tap into your university’s career services which often have specific connections to pharma companies looking to fill temporary roles. They might even have exclusive internship programmes that lead to temp jobs!
✨Be Visible Online and Offline
Utilise platforms like LinkedIn to share your interests in temporary roles and connect with industry professionals. Plus, consider writing about relevant pharmaceutical topics to showcase your knowledge and enthusiasm—this can help you stand out to hiring companies like Jazz Pharmaceuticals.
We think you need these skills to ace Senior QA Specialist, Pharmaceutical Development Quality Assurance (Maternity Leave Cover - Remote / Home Based) in Lisburn
Some tips for your application 🫡
Highlight Your Relevant Experience:In the pharmaceutical industry, it's crucial to showcase any relevant experience you have, whether it's internships, lab work, or coursework. Let’s emphasise your familiarity with drug development processes and any hands-on experience you've had with lab equipment or clinical trials in your CV.
Mention Certifications and Training:If you’ve got any certifications relevant to pharmaceuticals, like Good Clinical Practice (GCP) or a certification in pharmacovigilance, make sure to include them. These show your commitment to the field and can make a positive impact on your application for a temporary role at Jazz Pharmaceuticals.
Show Your Flexibility and Availability:Temporary positions often require immediate availability and flexibility in working hours. In your cover letter, make it clear when you can start and your ability to adapt to changing schedules, as this is key to a successful application.
Express Your Learning Goals:Since this is a temporary role, we suggest discussing what you hope to learn or gain from the experience at Jazz Pharmaceuticals. This not only shows your eagerness but also helps employers see you as someone who’s ready to make the most out of the opportunity.
How to prepare for a job interview at Jazz Pharmaceuticals
✨Know Your Regulations
In the pharmaceutical industry, it’s crucial to understand key regulations like GMP (Good Manufacturing Practices) or GCP (Good Clinical Practices). Brush up on these standards and be ready to discuss how they influence your work approach during your interview with Jazz Pharmaceuticals.
✨Emphasise Adaptability
Since this is a temporary role, show that you're ready to hit the ground running. Share examples from your past experiences that demonstrate your ability to adapt quickly to new environments or changes, especially in a fast-paced setting like pharmaceuticals.
✨Highlight Relevant Skills and Tools
Whether it’s laboratory techniques or software like LabWare or SAS, make sure you can confidently talk about your technical skills. If you have experience with any specific tools used in previous roles, relate that directly to how it can help Jazz Pharmaceuticals achieve its goals.
✨Prepare for Technical Questions
Be ready for technical questions related to drug development processes or quality assurance. We should expect scenarios where you might have to troubleshoot a problem or suggest improvements on a project—this shows your problem-solving capability in a temporary role.
