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- Tasks: Conduct audits globally to ensure compliance with GMP standards and manage audit programmes.
- Company: Join Norbrook, a leading pharmaceutical company committed to quality and innovation.
- Benefits: Enjoy 32 days annual leave, healthcare cash plan, and career development opportunities.
- Why this job: Make a real impact in the pharmaceutical industry while developing your auditing skills.
- Qualifications: Bachelor's degree and significant experience in GxP audits required.
- Other info: Dynamic team environment with ongoing training and support from experts.
The predicted salary is between 36000 - 60000 £ per year.
Norbrook are seeking to recruit a Senior GMP auditor to join the core auditing team within the Corporate Quality Assurance team.
Main Activities/Tasks
- Conducting On-Site, Virtual and paper based external audits/inspections of current and potential API suppliers, Packaging suppliers, sub-contractors and service providers across the globe, to assess the compliance of the organisations with their GMP obligations. This will include the planning and report writing associated with the audits.
- Manage the annual audit program of suppliers, sub-contractors and service providers as required and aligned with the other auditors within Norbrook Laboratories Limited.
- Review of all incoming audit reports from the Norbrook auditors and third party contractors to ensure consistency of approach and observation categorisation.
- Assessing the adequacy of CAPA responses from inspected organisations and assuring timely closure of same through regular review.
- Assist with the maintenance of the risk register established for all Norbrook's suppliers/manufacturers and third party contractors.
- Conducting internal audits/inspections of departments within Norbrook Laboratories Limited, both scheduled and ad hoc, to assess the compliance of departments with GMP requirements.
- When required, review the evidence of CAPA closures throughout the Norbrook facilities and support structure.
Essential criteria:
- Bachelor's degree (or equivalent).
- Significant experience in the pharmaceutical industry.
- A minimum of three years' experience conducting GxP audits.
- Extensive experience performing both internal and external audits.
- Strong knowledge of cGMP, quality system standards, and regulatory requirements such as 21 CFR, ICH, ISO, etc.
- Ability to evaluate suppliers against different quality system standards.
- Ability to communicate effectively and constructively across departmental and external functions.
- Strong written and interpersonal communication skills.
- Ability to travel approximately 35-40% of the working year.
- Ability to handle multiple responsibilities and job tasks, as needed.
Desirable criteria:
- Bachelor's degree in a physical science (Chemistry, Biology, etc.).
- Experience performing international audits.
- Experience in a vendor management role.
- Qualified Lead Auditor status, e.g., IRCA.
Additional Information:
- Applicants should be able to provide proof that they have a right to work in the UK at the time of their application. Applicants who are unable to provide this proof will not be considered.
- We regret that applications received after the closing date and time will not be accepted.
- We are unable to sponsor or take over sponsorship of a Visa at this time.
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.
- Employee recognition scheme.
- Career development opportunities.
Norbrook Laboratories Limited employs a workforce with members of all sections of the community and is committed to appointing people purely on the basis of merit. In accordance with our equal opportunities policy, we would particularly like to welcome applicants from the Protestant Community.
To Apply Please forward your CV via the APPLY Now button below.
Senior GMP Auditor in Newry employer: Norbrook
Contact Detail:
Norbrook Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior GMP Auditor in Newry
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who have experience with GMP audits. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of cGMP and quality system standards. We recommend creating a list of common interview questions related to auditing and practising your responses to show off your expertise.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you email to express your appreciation. It keeps you fresh in their minds and shows your enthusiasm for the role.
✨Tip Number 4
Apply through our website for the best chance at landing that Senior GMP Auditor role. We’re always on the lookout for passionate candidates, and applying directly helps us see your application first!
We think you need these skills to ace Senior GMP Auditor in Newry
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior GMP Auditor role. Highlight your relevant experience in GxP audits and any specific knowledge of cGMP and regulatory requirements. We want to see how your background aligns with what we're looking for!
Showcase Your Skills: Don’t just list your skills; demonstrate them! Use examples from your past experiences to show how you've effectively communicated across departments or managed multiple responsibilities. This will help us see you in action.
Be Clear and Concise: When writing your application, clarity is key. Keep your language straightforward and avoid jargon unless it's relevant. We appreciate a well-structured application that gets straight to the point!
Apply Through Our Website: We encourage you to apply through our website using the 'APPLY Now' button. This ensures your application goes directly to us and helps streamline the process. Plus, it’s super easy!
How to prepare for a job interview at Norbrook
✨Know Your GMP Inside Out
Make sure you brush up on your knowledge of current Good Manufacturing Practices (cGMP) and relevant regulatory requirements like 21 CFR and ISO standards. Being able to discuss these confidently will show that you're not just familiar with the concepts, but that you can apply them in real-world scenarios.
✨Prepare for Scenario-Based Questions
Expect questions that ask you to describe how you've handled specific situations in past audits. Think about examples where you assessed CAPA responses or managed audit programmes. Use the STAR method (Situation, Task, Action, Result) to structure your answers clearly.
✨Showcase Your Communication Skills
As a Senior GMP Auditor, you'll need to communicate effectively across various departments and with external suppliers. Prepare to demonstrate your interpersonal skills during the interview by discussing how you've successfully navigated challenging conversations or facilitated collaboration in previous roles.
✨Ask Insightful Questions
At the end of the interview, have a few thoughtful questions ready about Norbrook's auditing processes or their approach to supplier management. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.
