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- Tasks: Manage regulatory requirements and ensure compliance in pharmaceutical processes.
- Company: Leading organisation in the pharmaceutical industry with a focus on quality excellence.
- Benefits: 12-month contract with competitive pay and opportunities for professional growth.
- Other info: Join a diverse team committed to equal opportunities and innovation.
- Why this job: Make a real impact in the pharmaceutical sector while enhancing your regulatory expertise.
- Qualifications: Degree in a scientific or regulatory discipline and experience in regulatory intelligence.
The predicted salary is between 42000 - 60000 £ per year.
A leading organisation in the pharmaceutical industry is seeking a Senior Process Quality Excellence Specialist for a 12‑month contract based in the Berkshire area. As the Senior Process Quality Excellence Specialist, you will play a crucial role in managing Regulatory Intelligence requirements.
Key Duties And Responsibilities
- Act as the RIN coordinator, collaborating with Subject Matter Experts (SMEs) to ensure regulatory and guidance requirements are met in controlled documents.
- Review regulations and identify appropriate SMEs based on the topic, ensuring compliance with regulatory standards.
- Serve as a point of contact to confirm that Contract Research Organisations (CROs) have assessed regulatory and country‑specific regulations impacting their Standard Operating Procedures (SOPs) and company studies.
- Work with the Auditing team to host and coordinate internal Quality Audits, assisting SMEs in responding to audit queries, managing post‑audit responses, and implementing Corrective and Preventive Actions (CAPAs).
Role Requirements
- Relevant degree in a scientific or regulatory discipline.
- Proven industry experience in regulatory intelligence and quality management within the pharmaceutical sector.
- Working knowledge and practical experience with audit coordination and regulatory compliance.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements.
Seniority Level: Mid‑Senior level
Employment Type: Contract
Job Function: Management and Manufacturing
Industries: Biotechnology Research and Pharmaceutical Manufacturing
Senior Process Quality Excellence Specialist employer: Hyper Recruitment Solutions
Contact Detail:
Hyper Recruitment Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Process Quality Excellence Specialist
✨Tip Number 1
Network like a pro! Reach out to professionals in the pharmaceutical industry on LinkedIn or at local events. We can’t stress enough how valuable personal connections can be in landing that Senior Process Quality Excellence Specialist role.
✨Tip Number 2
Prepare for interviews by brushing up on your regulatory intelligence knowledge. We recommend creating a list of potential questions related to compliance and quality management, so you’re ready to impress when it’s your turn to shine!
✨Tip Number 3
Showcase your experience with audits and CAPAs during interviews. We want you to highlight specific examples where you’ve successfully managed these processes, as they’re crucial for the role you’re aiming for.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Senior Process Quality Excellence Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Process Quality Excellence Specialist role. Highlight your relevant experience in regulatory intelligence and quality management, and don’t forget to mention any specific projects that showcase your skills.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for this role. Mention your experience with audit coordination and how you’ve successfully managed compliance in previous positions.
Showcase Your Collaboration Skills: Since this role involves working with SMEs and CROs, make sure to highlight your teamwork and communication skills. Share examples of how you’ve collaborated effectively in past roles to meet regulatory requirements.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and ensure it gets the attention it deserves!
How to prepare for a job interview at Hyper Recruitment Solutions
✨Know Your Regulations
Familiarise yourself with the latest regulations in the pharmaceutical industry. Be prepared to discuss how you’ve navigated regulatory requirements in past roles, and think of specific examples where you ensured compliance.
✨Engage with SMEs
Since collaboration with Subject Matter Experts is key, come ready to discuss how you’ve worked with SMEs in the past. Highlight your communication skills and any strategies you used to ensure everyone was on the same page.
✨Audit Experience Matters
Be ready to share your experiences with audit coordination. Think about challenges you faced during audits and how you managed post-audit responses or implemented CAPAs. This will show your problem-solving skills and attention to detail.
✨Ask Insightful Questions
Prepare thoughtful questions about the company’s approach to regulatory intelligence and quality management. This shows your genuine interest in the role and helps you assess if the company aligns with your career goals.