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- Tasks: Lead and manage quality compliance in engineering to ensure life-saving medicines meet the highest standards.
- Company: Join SERB, a fast-growing pharmaceutical company dedicated to saving lives worldwide.
- Benefits: Competitive salary, benefits package, and a supportive team culture.
- Why this job: Make a real impact on patient care while working with innovative technologies.
- Qualifications: Project management skills and excellent communication abilities are essential.
- Other info: Dynamic environment with opportunities for professional growth and development.
The predicted salary is between 43200 - 72000 £ per year.
Come and Save Lives with Us! 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.
To be successful in this role
- 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 in London employer: BTG PLC
Contact Detail:
BTG PLC Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Engineering Compliance Manager in London
✨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 to save lives and think about how your skills align with their goals. This will help you stand out as a candidate who truly gets what they’re about.
✨Tip Number 3
Practice your answers to common interview questions, especially those related to compliance and quality management. Use the STAR method (Situation, Task, Action, Result) to structure your responses and showcase your achievements.
✨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 joining our team at SERB.
We think you need these skills to ace Engineering Compliance Manager in London
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 saving lives through quality compliance. Share specific examples of how you've improved processes or ensured compliance in previous roles to grab our attention.
Showcase Your Communication Skills: As an Engineering Compliance Manager, you'll need to communicate effectively with various teams. Use your application to demonstrate your communication skills—whether it's through clear language or structured formatting.
Apply Through Our Website: We encourage you to apply directly through our website. This way, your application goes straight to us, and we can review it promptly. Plus, it shows you're keen on joining our team!
How to prepare for a job interview at BTG PLC
✨Know Your Compliance Inside Out
Make sure you brush up on the latest cGMP regulations and quality management systems. SERB is all about maintaining high standards, so being able to discuss how you’ve ensured compliance in past roles will show you’re the right fit.
✨Showcase Your Project Management Skills
Prepare examples of how you've successfully managed multiple projects or compliance activities simultaneously. Highlight your ability to coordinate tasks under pressure, as this role requires juggling various responsibilities.
✨Communicate Clearly and Confidently
Practice articulating your thoughts clearly, especially when discussing technical topics. SERB values excellent communication, so be ready to explain complex ideas in a straightforward manner during your interview.
✨Demonstrate Your Strategic Thinking
Think about how you can contribute to operational excellence at SERB. Prepare to discuss innovative ideas or improvements you've implemented in previous roles that align with their goal of enhancing product quality and process efficiency.
