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For Companies At a Glance
- Tasks: Lead and manage engineering compliance to ensure top-notch quality in life-saving medicines.
- Company: Join SERB, a fast-growing specialty pharmaceutical company making a global impact.
- Benefits: Competitive pay, great benefits, and a supportive team culture.
- Why this job: Make a real difference in healthcare while developing your career in a dynamic environment.
- Qualifications: Project management skills and excellent communication abilities are essential.
- Other info: Be part of a team that values integrity, accountability, and innovation.
The predicted salary is between 36000 - 60000 £ per year.
SERB is a fast-growing specialty pharmaceutical company that equips healthcare providers worldwide with life-saving medicines for patients facing rare conditions and emergencies. For over 30 years we have consistently provided emergency medicines, medical countermeasures, and the world’s leading portfolio of antidotes. Today SERB has over 500 employees in 18 countries and group revenue in excess of €400m. With a strong presence in the US, Europe, and the Middle East, along with a global network of trusted distribution partners, we make a broad range of essential medicines available in over 100 countries.
Having the right culture is as important to us as having the right portfolio. We are guided by our four values:
- We make patients our priority
- We act with accountability and integrity
- We work together as one team
- We look for better ways forward
By expanding our reach through selective acquisitions and entering new markets, we’re not just supplying medicine; we’re improving the standard of care for more patients around the world.
Broad Overview
The Compliance Engineering Manager will lead, manage and coordinate Quality related cGMP Engineering practices as aligned with our Quality Management System (QMS). To ensure that engineering expertise is provided to the site, maintaining Regulatory requirements and industry best practices at all times and ensure cGMP is consistently met. The Compliance Engineering Manager will further support our Asset Management system (Maximo), EHS, Calibration and SCADA systems. To play a key role in ensuring that our products meet the highest standards of quality and compliance.
Responsibilities
- Ensure Engineering QMS maintenance, in compliance with internal procedures and regulatory standards.
- Stay updated on industry trends and regulatory changes to ensure ongoing compliance and quality improvement within Engineering.
- Manage Engineering Quality compliance activities (Deviations, Change Controls, CAPA, RCA), ensuring timely execution of investigations, CAPAs, providing and gathering stakeholder input to support ongoing activities.
- Monthly reporting of quality performance metrics and planning of any corrective/preventative improvement opportunities.
- Carry out departmental periodic reviews and support document reviews, amendments, and creation.
- To ensure department SOPs are up-to-date and accurate with changes.
- Support the Engineering coordinator in the maintenance of the Maximo Asset Management system.
- Working with the Engineering Manager to support timely closure of unplanned maintenance requests.
- Support the operation and maintenance of the SCADA system.
- Ensure SCADA systems are properly integrated with production processes and quality control measures.
- Review SCADA data to identify trends, deviations, and areas for improvement.
- Lead initiatives in operational excellence to improve product quality and process efficiency.
- Collaborate with cross-functional teams to implement best practices and innovations in quality management.
- Responsible for Engineering cGMP Regulatory and EHS audit preparation and hosting.
Qualifications
- A dynamic goal-orientated professional.
- Project management aptitude.
- Excellent communicator at all levels.
- Must be able to work under pressure and co-ordinate several activities concurrently.
- Logical and numerate with an aptitude for detail.
- The ability to chair and present at meetings to ensure results are achieved.
- A keen strategic thinker who is willing to apply new concepts and ideas to take the business forward.
Serb Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.
Engineering Compliance Manager employer: Thyroxine SERB
Contact Detail:
Thyroxine SERB Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Engineering Compliance Manager
✨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 SERB and its values. Understand their mission and how your skills align with their goals. This will help you stand out as someone who truly gets what they’re about.
✨Tip Number 3
Practice your responses to common interview questions, especially those related to compliance and quality management. Being articulate and confident can make all the difference when it comes to landing that role.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re genuinely interested in being part of the SERB team.
We think you need these skills to ace Engineering Compliance Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Engineering Compliance Manager role. Highlight your relevant experience in cGMP practices and quality management systems, as this will show us you understand what we're looking for.
Craft a Compelling Cover Letter: Your cover letter should tell us why you're passionate about compliance engineering and how your values align with ours. Share specific examples of how you've improved quality or compliance in previous roles to grab our attention.
Showcase Your Communication Skills: As an Engineering Compliance Manager, you'll need to communicate effectively at all levels. Use your application to demonstrate your communication skills—whether it's through clear language in your CV or engaging storytelling in your cover letter.
Apply Through Our Website: We encourage you to apply directly through our website. This not only streamlines the process but also ensures that your application reaches us quickly. Plus, it shows us you're proactive and keen to join our team!
How to prepare for a job interview at Thyroxine SERB
✨Know Your Compliance Inside Out
Make sure you’re well-versed in cGMP regulations and the Quality Management System (QMS) relevant to the role. Brush up on recent industry trends and regulatory changes, as this will show your commitment to maintaining high standards of quality and compliance.
✨Showcase Your Project Management Skills
Prepare examples from your past experiences where you successfully managed multiple projects or compliance activities. Highlight your ability to coordinate several activities concurrently, as this is crucial for the Engineering Compliance Manager role.
✨Communicate Effectively
Practice articulating your thoughts clearly and confidently. Since excellent communication is key for this position, be ready to discuss how you’ve effectively communicated with cross-functional teams and stakeholders in previous roles.
✨Demonstrate Your Strategic Thinking
Think about how you can apply new concepts and ideas to improve processes. Be prepared to discuss specific initiatives you've led that resulted in operational excellence or enhanced product quality, as this aligns perfectly with what SERB is looking for.
