At a Glance
- Tasks: Support pharmaceutical development with study design, reporting, and problem resolution.
- Company: Join a leading pharmaceutical company focused on innovation and compliance.
- Benefits: Enjoy 32 days annual leave, healthcare cash plan, and career development opportunities.
- Other info: Dynamic role with hands-on involvement in batch manufacturing and process validation.
- Why this job: Make a real impact in the pharmaceutical industry while growing your expertise.
- 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 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 professional growth, offering comprehensive benefits such as a generous annual leave policy, healthcare cash plan, and career development opportunities. With a commitment to excellence and community support through our WeCare programme, we provide an environment where your contributions are valued and recognised.
StudySmarter Expert Advice🤫
We think this is how you could land Study Director
✨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 recent projects, so you can tailor your answers and show them you're genuinely interested in being part of their team.
✨Tip Number 3
Practice makes perfect! Do mock interviews with friends or family to get comfortable with common questions. This will help you articulate your experience and skills confidently when it counts.
✨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 are proactive about joining our team!
We think you need these skills to ace Study Director
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 for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy – just hit that APPLY Now button and you’re good to go!
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 from your past work where you had to troubleshoot or provide technical support. Be ready to explain your thought process and how you approached those challenges.
✨Show Your Collaborative Spirit
This role involves a lot of teamwork, so be prepared to talk about how you've collaborated with different departments in the past. Share examples of how you influenced design or implemented strategies in a team setting. Highlighting your ability to work well with others will set you apart.
✨Stay Updated on Industry Guidelines
Demonstrate your awareness of current guidelines in the UK/Ireland, EU, US, and ROW regarding industry best practices. Mention any recent changes or trends you've noticed and how they might impact the role. This shows that you're proactive and committed to staying informed in your field.
