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For Companies At a Glance
- Tasks: Lead quality assurance initiatives and monitor performance across operational units.
- Company: Join Norbrook Laboratories, a leader in the pharmaceutical industry.
- Benefits: Attractive salary, career growth, and a commitment to diversity.
- Why this job: Make a real impact on quality standards in a dynamic environment.
- Qualifications: Five years in quality auditing or operations, with strong GMP knowledge.
- Other info: Opportunity to work with cross-functional teams and enhance your skills.
The predicted salary is between 36000 - 60000 £ per year.
We are currently recruiting for Site Corporate Quality Lead within our Corporate QA department. The purpose of the role is to set and monitor Key Performance Indicators for quality at operational business units. The candidate will also perform quality reviews of operational business units to cGMP and escalate identified excursions from expectations to senior site operational and quality management.
Key Skills
- Excellent knowledge of EU and US GMP
- Good communication skills; oral and written, e.g., interpersonal and technical report writing skills.
- Participate as part of a cross functional team
- Good planning and organisational skills with the ability to prioritise and work effectively on multiple tasks.
- Strong data interpretation and problem solving skills.
- Ability to lead projects where members are drawn cross-functionally
Main Activities/Tasks
- Based on a rotational basis at individual operational business units, monitor quality performance of the operational units to cGMP and escalate identified issues to site leadership (quality and operational) for further action.
- Ensure that plans are provided by the operational business unit owners to address all identified discrepancies from expected quality performance.
- Check effectiveness of corrective plans.
- Perform internal quality audits as assigned by Internal Audit management.
- Participate in manufacturer, supplier and sub-contractor audits as required.
- Identify key performance indicators for site operational quality performance and communicate these and monitor and report on the KPIs.
- Supply regular reports of KPI statistics and observations to the Senior Management.
- Manage any assigned market actions associated with the operational business units and ensure that site operational business unit leadership provide reports and CAPAs on a timely basis to meet the expected timeframes.
- Review and where appropriate approve or authorise SOPs or other GMP documents where appropriate.
- Participate in customer and competent authority audits of Norbrook as required.
- Undertake any ad hoc duties as required to sustain improvement and compliance of the quality system in Norbrook Laboratories Ltd.
Essential Criteria:
- Minimum five years' experience in a quality auditing or operations quality assurance role in the pharmaceutical industry.
- Third level qualification (a scientific or engineering discipline would be preferred but not essential)
- Excellent working knowledge of current Good Manufacturing Practices (cGMP) for both EU and US
- Experience identifying and investigating excursions from GMP and the implementation of corrective actions
- Experience of leading or participating in Quality Management System audits.
Desirable Criteria:
- Knowledge of sterile and non-sterile pharmaceutical product manufacturing, filling processes and analytical processes.
- Knowledge of validation activities/methodologies
- Experience leading a Quality Assurance function in an operational/production environment
- Experience of field market actions such as product defect reporting, batch/product recall activities.
Location: Newry, Co. Down
Remuneration: Salary Attractive
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.
Site Corporate Quality Lead in Newry employer: Norbrook
Contact Detail:
Norbrook Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Site Corporate Quality Lead in Newry
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who know about quality assurance roles. A friendly chat can lead to insider info or even a referral that could land you an interview.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of cGMP and quality management systems. We recommend creating a list of common interview questions related to quality assurance and practising your responses. Confidence is key!
✨Tip Number 3
Showcase your problem-solving skills during interviews. Think of specific examples where you've identified issues and implemented corrective actions. This will demonstrate your ability to handle the responsibilities of the Site Corporate Quality Lead role.
✨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 their job search.
We think you need these skills to ace Site Corporate Quality Lead in Newry
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Site Corporate Quality Lead role. Highlight your experience in quality auditing and operations quality assurance, especially in the pharmaceutical industry. We want to see how your skills match what we're looking for!
Show Off Your Skills: Don’t forget to showcase your excellent communication skills and your ability to lead cross-functional teams. Use specific examples from your past experiences to demonstrate how you've successfully managed multiple tasks and projects.
Be Clear and Concise: When writing your application, keep it clear and concise. We appreciate well-structured information that gets straight to the point. Avoid jargon unless it's relevant to the role, and make sure your technical report writing skills shine through!
Apply Through Our Website: Remember to apply through our website using the 'APPLY Now' button! It’s the best way for us to receive your application and ensures you’re considered for the role. We can’t wait to see what you bring to the table!
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) for both EU and US regulations. Be prepared to discuss specific examples of how you've applied these practices in your previous roles, as this will show your expertise and understanding of the industry.
✨Showcase Your Communication Skills
Since excellent communication is key for this role, practice articulating your thoughts clearly and concisely. Prepare to discuss how you've effectively communicated quality issues or solutions in past experiences, whether through reports or team discussions.
✨Demonstrate Problem-Solving Prowess
Think of specific instances where you've identified quality discrepancies and implemented corrective actions. Be ready to explain your thought process and the steps you took to resolve these issues, as this will highlight your strong data interpretation and problem-solving skills.
✨Prepare for Cross-Functional Collaboration
This role involves working with various teams, so be ready to share examples of how you've successfully collaborated across functions. Highlight any projects where you led or participated in cross-functional teams, showcasing your planning and organisational skills.
