At a Glance
- Tasks: Ensure quality compliance and oversee operations across EU sites in the pharmaceutical industry.
- Company: Join a leading pharmaceutical company focused on quality and compliance.
- Benefits: Competitive salary, career growth opportunities, and a dynamic work environment.
- Other info: Collaborative team culture with opportunities for continuous improvement and learning.
- Why this job: Make a real impact on quality assurance in a fast-paced industry.
- Qualifications: Experience in Quality Assurance or Regulatory roles within the pharmaceutical sector.
The predicted salary is between 36000 - 60000 £ per year.
The Quality Specialist – EU Operations will support the PPS EU Quality Manager in overseeing the Quality Management Systems across the EU Leiden office, as well as managing interactions with the Morpeth and India sites. The role ensures that business and compliance objectives are achieved in line with monthly sales and revenue goals.
You will work closely with the Supply Chain team to ensure that the importation of finished products into the EU is conducted through registered sites and in compliance with all applicable Good Distribution Practice (GDP) regulations and other relevant laws.
Key responsibilities include:
- Management and maintenance of the Manufacturing/Importation Licence for Piramal Dutch BV.
- Adherence to EU Good Manufacturing Practices (GMP).
- Ensuring compliant batch disposition in collaboration with EU Qualified Persons (QPs).
- Proactive Quality oversight and effective stakeholder coordination.
- Continuous improvement to maintain compliance while driving operational efficiency.
- Support and ensure Quality oversight of the EU Leiden office and all associated interactions with Morpeth and India sites.
- Establish, track, and report on Key Performance Indicators (KPIs) for quality, safety, delivery, and cost.
- Ensure the Morpeth and India PTP QMS incorporates all EU office requirements.
- Travel to the EU office as needed to maintain effective Quality oversight and support all Piramal and customer quality needs.
- Coordinate with Morpeth and India teams to ensure timely vendor management, self-inspections, and other activities impacting the EU supply chain.
- Support all customer and regulatory audits of the PPS BV office.
- Oversee day-to-day operations between EU contract testing providers, storage/distribution depots, and Morpeth/India sites to ensure timely batch disposition.
- Provide relevant Quality metrics for business performance reporting.
- Work with QA Client Liaison Officers to ensure accurate and timely communication as per relevant Quality Technical Agreements (QTAs).
- Escalate any Quality issues to the PPS EU Manager as required.
- Support and lead continuous improvement initiatives to enhance both compliance and efficiency.
- Stay up to date with EU–UK regulatory changes and ensure these are adequately implemented within the QMS.
- Maintain current QTAs and QP-QP agreements affecting the EU office.
- Act as the primary point of contact between the EU office, Morpeth, and India sites in the absence of the PPS EU Manager.
- Monitor and evaluate the performance of EU contract testing facilities using KPI reviews and regular business meetings.
- Align activities with PPS business goals, ensuring EU operations support broader sales, financial, and customer service objectives.
- Support the PPS EU Manager in responding to new customer inquiries, contributing to business growth across all Piramal facilities requiring EU-based services.
Significant experience within the pharmaceutical industry in a Quality Assurance, Quality Control, or Regulatory role. Ability to apply regulatory requirements using a pragmatic, risk-based approach. Proven experience managing regulatory processes within EU quality operations.
Quality Auditor / QA / QC employer: Piramal Pharma Solutions
Piramal Dutch BV is an exceptional employer, offering a dynamic work environment in the heart of Leiden, where employees are empowered to drive quality and compliance in the pharmaceutical industry. With a strong focus on continuous improvement and professional development, team members benefit from collaborative interactions with global sites, ensuring meaningful contributions to business growth while adhering to the highest standards of Good Manufacturing Practices. The company fosters a culture of innovation and accountability, making it an ideal place for those seeking rewarding careers in Quality Assurance and Regulatory roles.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Auditor / QA / QC
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect with professionals on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with your own. This will help you tailor your responses and show that you're genuinely interested in the role.
✨Tip Number 3
Practice common interview questions and scenarios related to Quality Assurance and Compliance. Use the STAR method (Situation, Task, Action, Result) to structure your answers and demonstrate your problem-solving skills effectively.
✨Tip Number 4
Don’t forget to follow up after interviews! A simple thank-you email can leave a lasting impression and keep you on their radar. Plus, it shows your enthusiasm for the position and the company.
We think you need these skills to ace Quality Auditor / QA / QC
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Specialist role. Highlight your experience in Quality Assurance, Quality Control, or Regulatory roles within the pharmaceutical industry. We want to see how your skills align with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality management and how you can contribute to our team. Be sure to mention your proactive approach and any relevant achievements.
Showcase Your Regulatory Knowledge:Since this role involves compliance with Good Distribution Practice (GDP) and Good Manufacturing Practices (GMP), make sure to showcase your understanding of these regulations. We love candidates who can demonstrate their knowledge and practical application!
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at Piramal Pharma Solutions
✨Know Your Quality Standards
Familiarise yourself with the key quality standards relevant to the role, such as Good Distribution Practice (GDP) and Good Manufacturing Practices (GMP). Be ready to discuss how you've applied these in your previous roles, as this will show your understanding of the industry and its regulations.
✨Showcase Your Stakeholder Coordination Skills
Prepare examples that highlight your experience in coordinating with various stakeholders. This could include working with supply chain teams or managing vendor relationships. Demonstrating your ability to communicate effectively across different teams will be crucial for this role.
✨Be Ready to Discuss Continuous Improvement
Think of specific instances where you've led or contributed to continuous improvement initiatives. Be prepared to explain the impact of these initiatives on compliance and operational efficiency, as this aligns with the company's goals.
✨Stay Updated on Regulatory Changes
Research recent changes in EU-UK regulations that may affect the pharmaceutical industry. Being able to discuss these changes and their implications during your interview will show your proactive approach and commitment to staying informed in your field.
