Smart Recruit Online Ltd
Wales, Flintshire
£0.00 per annum
28 Nov 2016
13 Dec 2016
Smart Recruit Online
Contract Type
Full Time

We exist to improve the lives of the people we touch. In the areas of healthcare that we serve, we feel a deep and personal connection to our customers, many of whom rely on us to help them lead the life they want. Our vision is to be the most respected and successful MedTech company, worldwide. We drive for excellence in all we do - anticipating and addressing our customers' needs with advanced technologies and best-in-class products and services. Ours is a global business, well positioned for long term sustainable performance and culturally rooted in our core values of caring for people, continually driving innovation and excellence, and earning trust, every day and in everything we do.

We are currently recruiting for a Microbiologist based at our Advanced Wound Care Manufacturing site in Deeside, North Wales. The role is responsible for ensuring all laboratory practices meet regulatory and procedural requirements.

Specific Responsibilities:

  • Ensure facilities, processes, personnel and materials/products are microbiologically tested in line with cGMP and procedural requirements
  • Provide microbiological support for Operations
  • Utilise the SAP business system to facilitate product release
  • Responsible for the sterilisation validation programme to maintain compliance with ISO 11137, 11135 and 17765
  • Ensure compliance is maintained as directed by Notified Bodies regulations
  • Compliance with GMP requirements and uphold these standards
  • Compliance with EHS requirements and uphold these standards
  • Seek and deliver CI opportunities across the site
  • Perform method validations
  • Adhere to legal, corporate and site legislation

Biology | Microbiology | Science | Medicine | Healthcare |

Essential Criteria:

  • Educated to degree level, or equivalent, within a Microbiological discipline
  • Demonstrated experience within a microbiology laboratory
  • Experience of ISO11737, 11137,11135, 17665, Pharmacopeia's references
  • Understanding of GMP and Quality Systems in a regulated environment.
  • Successful participation in a quality system in a complex and regulated manufacturing environment.
  • Exposure to data management and interpretation of the data sets.
  • Excellent written skills which have been used to author both technical reports and quality documents (specification and procedural based).