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- Tasks: Lead engineering compliance to ensure quality and regulatory standards in life-saving medicines.
- Company: Join SERB Pharmaceuticals, a fast-growing company dedicated to saving lives globally.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Why this job: Make a real impact in healthcare by ensuring the highest quality standards.
- Qualifications: Project management skills and excellent communication abilities are essential.
- Other info: Dynamic work environment with a focus on teamwork and innovation.
The predicted salary is between 36000 - 60000 £ 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. SERB has provided emergency medicines, medical countermeasures, and the world’s leading portfolio of antidotes for over 30 years. 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.
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.
Your responsibilities include:
- 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.
- Assist in the preparation of the engineering and project budgets, ensuring investment activities support ongoing regulatory compliance and include investment in improvements required to maintain compliance.
- Input into the Regulatory strategies and author the relevant sections of Regulatory dossiers and submissions.
- When required, responsibility over engineering day-to-day, standing in for the Engineering manager.
- Carry out other reasonable tasks as required by the Line Manager.
- Ensuring that all interactions and engagements are carried out in accordance with Company values.
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.
Engineering Compliance Manager - BTG Pharmaceuticals (now SERB Pharmaceuticals) employer: Jobster
Contact Detail:
Jobster Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Engineering Compliance Manager - BTG Pharmaceuticals (now SERB Pharmaceuticals)
✨Tip Number 1
Network like a pro! Reach out to current employees at SERB Pharmaceuticals on LinkedIn. Ask them about their experiences and any tips they might have for landing the Engineering Compliance Manager role. Personal connections can give you an edge!
✨Tip Number 2
Prepare for the interview by diving deep into SERB's values and mission. Think about how your experience aligns with making patients a priority and acting with integrity. We want to see that you’re not just a fit for the role, but also for our culture!
✨Tip Number 3
Showcase your project management skills! Be ready to discuss specific examples of how you've led compliance initiatives or improved quality processes in previous roles. We love hearing about real-life successes that demonstrate your capabilities.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining our team at SERB Pharmaceuticals.
We think you need these skills to ace Engineering Compliance Manager - BTG Pharmaceuticals (now SERB Pharmaceuticals)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Engineering Compliance Manager role. Highlight your experience with cGMP practices and quality management systems, as these are key for us at SERB Pharmaceuticals.
Craft a Compelling Cover Letter: Your cover letter should tell us why you’re passionate about compliance in the pharmaceutical industry. Share specific examples of how you've improved quality processes or managed compliance activities in the past.
Showcase Your Team Spirit: We value teamwork, so don’t forget to mention your collaborative experiences. Talk about how you’ve worked with cross-functional teams to implement best practices and drive operational excellence.
Apply Through Our Website: For the best chance of success, apply directly through our website. This way, we can easily track your application and ensure it reaches the right people in our team!
How to prepare for a job interview at Jobster
✨Know Your Compliance Inside Out
Make sure you brush up on the latest cGMP regulations and quality management systems. SERB Pharmaceuticals values accountability and integrity, so being able to discuss how you’ve ensured compliance in past roles will show you’re a great fit.
✨Showcase Your Project Management Skills
Prepare examples of how you've successfully managed multiple projects under pressure. Highlight your ability to coordinate activities and lead initiatives that improve product quality and process efficiency, as these are key aspects of the role.
✨Communicate Effectively
Practice articulating your thoughts clearly and confidently. Since the role requires excellent communication at all levels, be ready to demonstrate how you can chair meetings and present findings effectively to ensure results are achieved.
✨Emphasise Team Collaboration
SERB is all about working together as one team. Be prepared to discuss how you’ve collaborated with cross-functional teams in the past and share specific examples of how you’ve implemented best practices and innovations in quality management.
