At a Glance
- Tasks: Lead the Sterilisation and Aseptic Processing Validation team to ensure compliance with GMP standards.
- Company: Join a leading pharmaceutical company focused on quality and innovation.
- Benefits: Enjoy 32 days annual leave, healthcare cash plan, and career development opportunities.
- Other info: Free life assurance, subsidised canteen, and employee well-being initiatives.
- Why this job: Make a real impact in ensuring product safety and quality in a dynamic environment.
- Qualifications: Degree in relevant field or 5 years industry experience in sterile manufacturing.
The predicted salary is between 40500 - 49500 £ per year.
Reporting to the Head of Validations, the Validation Manager - Sterilisation leads the Sterilisation and Aseptic Processing Validation function, ensuring validation activities comply with GMP requirements, regulatory expectations, and company quality standards. You will provide technical leadership for sterilisation, aseptic processing, and contamination control validation, maintaining the validated state through lifecycle management, change control, periodic review, continuous improvement, and inspection readiness.
Main Activities/Tasks:
- Provide leadership, guidance, and performance management to the Sterilisation and Aseptic Process Validation team.
- Drive timely completion of deviations, change controls, risk assessments, OOS investigations, and CAPAs related to validation activities.
- Ensure validation protocols, reports, SOPs, Validation Master Plans, and technical documentation are prepared, reviewed, and approved in line with GMP and regulatory requirements.
- Communicate validation project status to support effective cross-functional collaboration and integration of validation requirements into business projects.
- Identify training needs and maintain team competency in GMP, sterilisation technologies, and regulatory expectations.
- Support the introduction of new equipment, facilities, and products requiring sterilisation or aseptic validation.
- Attend organisational and project meetings to promote validation requirements and timelines.
- Provide technical support and participate in internal, external, and regulatory audits and inspections.
Essential Criteria:
- Degree in Pharmaceutical Sciences, Engineering, Microbiology, Biotechnology, Chemistry or a related discipline, OR at least 5 years relevant industry experience.
- Proven experience and knowledge of sterile manufacturing, including sterilisation and aseptic processing.
- Comprehensive knowledge of GMP, specifically in relation to sterile manufacturing and sterilisation processes.
- Excellent organisational and planning skills, with the ability to communicate effectively across all organisational levels.
- Understanding of criteria to achieve successful porous load sterilisation, fluid load sterilisation, dry heat sterilisation, depyrogenation and sterilisation by radiation.
- Previous experience in achieving on-time-in-full validation schedule compliance.
Benefits:
- Free life assurance
- Pension salary sacrifice scheme with 5% employer contribution
- Healthcare cash plan
- 32 days annual leave (increasing with length of service)
- Wedding leave
- Enhanced Maternity / Paternity Pay
- Company Sick Pay
- Subsidised Canteen Facilities
- FREE On-site parking
- Cycle to Work Scheme
- Tech Purchase Scheme
- Free Will-Writing Service
- Employee perks/discounts scheme
- Employee Assistance Programme (EAP)
- Employee well-being initiatives
- Employee recognition scheme
- Career development opportunities
To Apply, please forward your CV via the APPLY Now button below.
Validation Manager (Permanent) in Newry employer: Norbrook
Norbrook Laboratories Limited is an exceptional employer located in Newry, offering a supportive work culture that prioritises employee well-being and development. With benefits such as a generous annual leave policy, enhanced maternity/paternity pay, and career growth opportunities, employees are encouraged to thrive both personally and professionally. The company also fosters a sense of community through initiatives like the Employee Assistance Programme and various employee recognition schemes, making it a rewarding place to work.
StudySmarter Expert Advice🤫
We think this is how you could land Validation Manager (Permanent) in Newry
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We think you need these skills to ace Validation Manager (Permanent) in Newry
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 Norbrook!
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 Norbrook 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 Norbrook!
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 Norbrook, 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 Norbrook
✨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 Norbrook 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 Norbrook’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.
