At a Glance
- Tasks: Support pharmaceutical development with study design, reporting, and problem resolution.
- Company: Leading pharmaceutical company focused on innovation and compliance.
- Benefits: Generous annual leave, healthcare plan, pension scheme, and employee perks.
- Other info: Great career development opportunities and a supportive work culture.
- Why this job: Join a dynamic team and make a real impact in the pharmaceutical industry.
- Qualifications: Degree in a scientific discipline and experience in a cGMP environment.
The predicted salary is between 40000 - 50000 € per year.
Main Activities/Tasks
- Technical support to the pharmaceutical development team to aid in both study design/reporting and in problem resolution.
- Compile and review protocols, reports, SOPs and Master Plans ensuring that they comply with GMP and safe working practices.
- Collaborate with Process Development/Tech Service Team/H&S/Engineering to influence the design and implementation of a robust process control strategy, provide process risk assessments and associated documentation to support equipment qualification activities, PPQ studies and key technical strategies and to provide compliance with the current TT SOP.
- Review PCR's generated for use in the production facility and ensure in line with the proposed manufacturing process as defined by Formulations or Regulatory Submission.
- Ensure that Out of Specification and Out of Trend results are fully investigated in line with the company's SOP's and Quality Management System.
- Maintain an awareness of current guidelines in UK/Ireland, EU, US and ROW in relation to industry best practice for Process Validations activities.
- Provide technical support to the regulatory department, where required, on all matters concerning PV studies undertaken by the Pharmaceutical Development Team.
- Participate in due diligence initiatives by acting as the subject matter expert for technology evaluation and all types of validation and work with colleagues in relation to validation of Facilities and Computerized Systems.
- Provide technical support to Manufacturing Operations through provision of expertise for investigation and resolution of process deviations, CAPAs, review and approval of change controls associated with New product introduction.
- Provide technical input and evaluation for GMP Investigations from the manufacturing facility.
- Oversee with hands-on involvement in batch manufacturing for development, pre-approval, engineering and pre-market commercial scale batches.
- Ensure compliance with EHS policy, cGMP and other business regulations and participate in risk assessments, audits and incident investigations.
- Ongoing technical support of Manufacturing Operations by providing technical expertise for investigation and resolution of process deviations, CAPAs, review and approval of change controls.
Essential Criteria:
- A degree in a scientific discipline.
- Previous experience working in a cGMP environment.
- Working knowledge of VICH guidelines.
- Practical working knowledge of process validation.
- Experience in the compilation of protocols, reports and interpretation of raw data.
Desirable Criteria:
- A process / chemical engineering background.
- 2 years' experience in a cGMP environment.
- Previous relevant experience in Process Validation and scale-up within a pharmaceutical company.
- Previous practical experience of scale-up from development to routine manufacture.
- Experience in scale-up of various pharmaceutical dosage forms.
Benefits:
- Free life assurance.
- Company pension scheme.
- Healthcare cash plan.
- 32 days annual leave.
- Wedding leave.
- Company sick pay.
- Employee well-being initiatives.
- Employee assistance programme.
- On-site free parking.
- Subsidised canteen facilities.
- WeCare programme - supporting the local community.
- Employee perks scheme.
- Employee recognition scheme.
- Career development opportunities.
To Apply: Please forward your CV via the APPLY Now button below.
Study Director in Newry employer: Norbrook
As a Study Director at our Newry location, you will join a dynamic team dedicated to pharmaceutical development, where innovation meets compliance. We pride ourselves on fostering a supportive work culture that prioritises employee well-being and growth, offering comprehensive benefits such as a generous annual leave policy, healthcare cash plan, and career development opportunities. Our commitment to community support and employee recognition ensures that you will not only thrive professionally but also contribute meaningfully to the local area.
StudySmarter Expert Advice🤫
We think this is how you could land Study Director in Newry
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect 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 role thoroughly. Understand their values and how your skills align with their needs. This will help you stand out and show that you're genuinely interested.
✨Tip Number 3
Practice common interview questions and have your own questions ready. This shows you're engaged and gives you a chance to assess if the company is the right fit for you too!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Study Director in Newry
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Study Director role. Highlight your experience in cGMP environments and any relevant technical skills that match the job description. We want to see how your background aligns with what we’re looking for!
Showcase Your Experience:When writing your application, don’t just list your previous jobs. Instead, showcase specific projects or tasks where you’ve demonstrated your expertise in process validation or protocol compilation. This helps us see your practical knowledge in action!
Be Clear and Concise:Keep your application clear and to the point. Use bullet points for easy reading and make sure to avoid jargon unless it’s relevant to the role. We appreciate straightforward communication that gets right to the heart of your qualifications.
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way to ensure your application gets to us directly. Plus, it shows you’re keen on joining the StudySmarter team. We can’t wait to hear from you!
How to prepare for a job interview at Norbrook
✨Know Your Stuff
Make sure you brush up on your knowledge of cGMP environments and VICH guidelines. Familiarise yourself with the specifics of process validation and be ready to discuss your previous experiences in detail. This will show that you're not just a good fit on paper, but you really understand the role.
✨Prepare for Technical Questions
Expect to face some technical questions related to study design and problem resolution. Think about scenarios where you've had to investigate deviations or CAPAs and be prepared to explain your thought process. Use examples from your past work to illustrate your expertise.
✨Show Your Collaborative Spirit
This role involves a lot of teamwork, so be ready to talk about how you've collaborated with different departments in the past. Highlight any experiences where you influenced process control strategies or worked with regulatory teams. It’s all about showing you can work well with others!
✨Stay Updated on Industry Guidelines
Demonstrate your commitment to staying informed by discussing current guidelines in the UK/Ireland, EU, and US regarding process validations. Showing that you’re proactive about keeping up with industry best practices will impress your interviewers and show you’re serious about the role.
