Compliance Engineer

Norgine

  • Hengoed, Caerphilly
  • Permanent
  • Full-time
  • 14 days ago
Job Description:Want a 3D Career? Join Norgine.At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.Bring everything about yourself that you're proud of, whether that's your passion for making a difference, focus on others' well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community.In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people's wellness as much as you do.Because at Norgine, we transform lives with innovative healthcare solutions.We have an exciting opportunity for a Compliance Engineer to join Norgine.Core ResponsibilitiesThis role is to ensure that products, systems, and processes adhere to applicable safety, quality, and regulatory standards. To conduct inspections, perform tests, and analyse data to identify areas of non-compliance and implement corrective actions.To ensure compliance of the site Calibration process, control the Engineering Maintenance Management Systems (EMMS) to ensure all planned, unplanned and reactive maintenance events are compliant and deputise for Compliance Team Leader where required.Requirements:Compliance
  • carry out calibration works across all relevant machines and processes, investigating any issues and correcting the problem,
  • Hands on fault finding, documenting and reporting root cause analysis, countermeasures in line with QMS procedures,
  • Manage EMMS system, by reviewing, approving and filing of Engineering Works Orders in line with approved SOP`s,
  • Supervision of administration support for issuing of Engineering Works Orders to schedule,
  • Manage, Engineering Task List (ETL) process, ensuring ETLs are compliant at all times,
  • Review current SOP`s and Develop suite of SOP`s to detail the site engineering maintenance strategy in line with EMMS and ISPE guides,
  • To support QA and Engineering department (Site Services & Maintenance Sections) on QMS investigations and countermeasures where required,
  • Support QA internal audit schedule, by performing internal audits as required,
  • Pro-active analysis of calibration and maintenance procedures and practices, regular reviews and updates in line with relevant good practice guides and improvement opportunities,
  • Develop and introduce risk analysis of current maintenance and calibration methods to reduce / increase tasks to ensure an efficient and compliant maintenance and calibration system,
  • To support QA and Engineering department (Site Services & Maintenance Sections) on other activities as directed when required,
OEE, H&S, and GMP
  • Maintaining tools and equipment, so that they are in a safe working condition; as well as making sure that the workshop and plant rooms are safe environments at all times,
  • Always adhere to technical procedures and good manufacturing processes (GMP),
  • Work in a clean and orderly manner in compliance with the company's hygiene code of practice,
  • Ensure all health and safety standards are met and that all equipment complies with company and legal standards.
Miscellaneous
  • Ensure work orders are completed on time,
  • Liaise effectively with external contractors,
  • Willing to learn new skills (on and off the job) and train others if and when required,
  • Represent the Engineering Department in Production Meetings and contribute to effective communication within the Engineering Team,
  • Make sure that there is good reporting and communication channels in place between production, the engineering team, and engineering management,
  • Develop and maintain good working relationship with production managers,
  • Present a good image of the engineering department, act in a professional and positive manner at all times,
  • Supports the company vision, goal and agreed targets,
  • Communicates effectively,
  • Builds and maintains relationships,
  • Acts decisively,
  • Demonstrates resilience flexibility,
  • Attention to detail,
  • Driver of change,
  • Works on own initiative,
  • Thinks systematically and inspires change,
  • Contributes own views
KEY RESPONSIBILITIES & ACCOUNTABILITIES:
  • Ensuring Health and Safety, Quality and Compliance are maintained to a high standard at all times,
  • Responding promptly to emergencies and addressing any disruptions,
  • Monitoring performance metrics, detecting issues, diagnosing faults, and implementing corrective actions,
  • Support QA and Engineering Department (Site Services & Maintenance Section) in compliance activities to meet FDA, MHRA & ISO 134845 - Medical Device requirements,
  • Meet the expectations of GxP, QMS and site Quality Standards,
  • Oversee and manage all systems involving Calibrations, Maintenance and Document Review.
SKILLS & KNOWLEDGE:
  • Have a proactive approach to fault finding, a commitment to continuous improvement, and personal development,
  • Must have the knowledge, discipline and initiative to work alone,
  • Practical attitude,
  • Applies a team approach to engineering issues,
  • Ability to work under pressure and to tight deadlines,
  • Must have effective communication skills (written and verbal),
  • Computer literate and a working knowledge of MS Office and a PPM system,
  • Ability to understand electrical and mechanical drawings/manuals
  • A logical and flexible approach to working,
  • Demonstrate a sense of urgency and should be proactive in driving through continuous improvement initiatives,
  • Possess excellent decision making skills.
Benefits:Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.Sound good? Find out more about the career you'll have with Norgine, then apply here.#LI-PP1

Norgine