QSHE Advisor
Donnington, UNITED KINGDOM Accounting / Management control
Job description
Are you a QSHE expert with a passion for precision? Look no further! We’re thrilled to introduce a pivotal role where you’ll be utilising all your skills.
Your Role
Using your expertise to advise and assure QSHE compliance within the specialised contract areas of Pharma, Medical Devises & Gases and Dangerous goods. With a primary function of conducting QSHE Audits and Inspections as required to ensure compliance with regulations in these specialist areas.Your Responsibilities
- To assure all warehouse and compliance activity is conducted in accordance with specific procedures and processes for Pharma, Medical Gases and Medical Devices, in accordance with GDP and other relevant standards and regulations. Through audit and inspection programmes.
- Assure technical requirements such as temperature mapping, temperature monitoring, cleaning and hygiene, pest control and premises and equipment validations are correctly implemented and recorded.
- Assure Risk Assessments are in place for ensuring patient safety/product quality/date integrity risks are factored into all activities regarding Medical Gases, Medical Devices, and equipment.
- Provide information and support to ensure adherence to the requirements to the medial device quality standard ISO13485 and the Medical Device Regulations including EU regulation 2017/745.
- Support Dangerous Goods Safety Advisor in the assurance of adherence to Dangerous Goods Procedures and Regulations through audit and inspection.
Your Skills and Experiences
- Experience within the Medical/pharmaceutical industry including GDP – Desirable
- Experience with Dangerous Goods assurance - Desirable
- Willingness to attend GDP and Lead Auditors Course – Essential
- An understanding of the compliance requirements for the transport and storage of Controlled Substances and the associated Home Office Guidance - Desirable
- Ability to interpret guidance and legislative requirements.
- Be able to interrogate data and compile relevant statistics
Please be aware that by applying for this role, you are agreeing to participate in the employment screening process. This process will include criminal record checking and identity validation. This means that KN will ask successful applicants to provide certain information and documentation to enable these checks to be conducted.
Any appointment will then be strictly conditional upon, and subject to, the receipt of satisfactory results of these checks