At a Glance
- Tasks: Ensure compliance and governance of Qualification and Validation activities while supporting continuous improvement.
- Company: Join Piramal Pharma Solutions, a global leader in drug development and manufacturing.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Dynamic work environment with excellent career advancement opportunities.
- Why this job: Make a real impact in the pharmaceutical industry with cutting-edge technologies.
- Qualifications: Technical or scientific qualification relevant to Q&V, plus strong communication skills.
The predicted salary is between 45000 - 60000 £ per year.
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider and experience with various technologies enables us to serve Innovator and Generic companies worldwide.
The role of the Senior Q&V Qualification and Validation Specialist is to ensure governance and compliance of Qualification and Validation (Q&V) and Periodic Review activities at Piramal Grangemouth. The position holder will have responsibility to coordinate, maintain and promote Q&V compliance, leading and supporting continuous improvement of related quality and operational systems. The role will support and ensure that the site and related functions are in compliance with GxP regulations and applicable quality guidelines, including, but not limited to UK/EU/US GMP/GDP, ICH, ISPE and other region specific guidance. The individual will have ownership for key Q&V quality system elements and will support and execute site quality and compliance improvements, working closely with relevant stakeholders on site.
Essential Qualifications: The holder will normally be expected to be qualified in a technical or scientific area which is relevant to the role. This may be through a formal educational/qualification route or via relevant experience and training obtained through practical application. It may also be a combination of both.
Essential Experience:
- Technical knowledge of qualification and validation systems for which the holder has responsibility.
- Relevant computer system skills.
- Communication skills – written (technical writing) and verbal.
- Presentation/training skills.
- Planning and prioritising.
- Client audit & Regulatory Agency Inspection experience.
- Teamwork.
Key Roles/Responsibilities:
- Provision of planning, support and guidance for validation projects. This includes:
- Ensuring continuous improvement of validation policies, procedures, templates and working practices.
- Oversight of project plans and milestones in conjunction with project teams in order to meet compliance and customer needs.
- Coordination, resource management and facilitation of validation projects.
- Provision of validation expertise, advice and guidance to the site, Q&V team and 3rd parties to ensure compliance with site policy and procedures.
- Establish validation documentation in conjunction with project teams and in compliance with relevant SOPs and good practice.
- Facilitation of the review and approval of validation documents.
- Practical support during protocol execution and reporting where required and appropriate.
- Oversight, metric reporting and provision of practical support to Periodic Review activities.
- Ensure management of the SVMP Inventory and SVMP Schedule with information provided by validation practitioners.
- Generation of training packages and delivery of training on validation related topics.
Maintain and develop knowledge of current regulatory expectations and industry best practices with respect to validation.
Competencies:
- Attention to detail.
- Thoroughness.
- Planning and Prioritisation.
- Good communication skills – written and verbal.
- Problem solving.
Senior Q&V Specialist in Grangemouth employer: Piramal Healthcare UK Limited
Piramal Healthcare UK Limited is an exceptional employer that fosters a dynamic and innovative work culture, ideal for professionals in the Pharmaceutical industry. With a strong emphasis on employee growth and development, we offer numerous opportunities for career advancement while providing a supportive environment that encourages collaboration and creativity. Located in a vibrant area, our team enjoys access to industry events and networking opportunities that enhance both personal and professional growth.
Contact Details:
Piramal Healthcare UK Limited Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Senior Q&V Specialist in Grangemouth
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Piramal Healthcare UK Limited. 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 Piramal Healthcare UK Limited.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Piramal Healthcare UK Limited. 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 Piramal Healthcare UK Limited is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Senior Q&V Specialist in Grangemouth
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 Piramal Healthcare UK Limited!
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 Piramal Healthcare UK Limited 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 Piramal Healthcare UK Limited!
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 Piramal Healthcare UK Limited, 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 Piramal Healthcare UK Limited
✨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 Piramal Healthcare UK Limited 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 Piramal Healthcare UK Limited’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.
