sterilisation assurance scientist in blackpool

posted
job type
contract
salary
£ 45,000 per year
apply now

job details

posted
location
blackpool, north west
job category
pharmaceutical
job type
contract
working hours
Full-Time
salary
£ 45,000 per year
reference number
SASBPJ
apply now

job description

Are you an experienced Sterilisation Assurance Scientist? Are you looking to take on a new challenge with a leading Medical Devices Manufacturer? If so we are looking for individuals just like you!

We are looking for a Sterilisation Assurance Scientist to be our clients expert on the application and practice of microbial assurance as applied to the design, manufacture and sterilization of implants while ensuring that the company meets all Corporate, FDA, Department of Health & Medical Device Directive and European Standards requirements.

This opportunity is a contract role, initially for 6 months, working 37 hours per week Mon-Fri.

Responsibilities:



* To implement the microbial assurance aspects of the Quality System
* To carry out regular microbial monitoring of all clean room facilities and water systems, to analyse the results and recommend corrective action where appropriate
* To oversee/co-ordinate use of all microbial services
* To review and develop procedures for all microbial assurance activities
* To carry out regular internal auditing of all clean room facilities and other areas
* To implement the GMP training program for clean room and other appropriate staff
* To be a member of New Product Development teams and undertake cleaning, microbial, sterilisation validation as required
* To be responsible for the release of sterile products
* To regularly audit the sterilization subcontractors, contract laboratories and clean room clothing suppliers
* Support the Quality team in the preparation for and performance of all third party inspections and audits as appropriate
* To create, review and approve change controls identifying Microbial impact and necessary actions in line with worldwide and local procedures
* To adhere to the Company's procedures as detailed in the SOP manual
* Maintain a detailed knowledge of AAMI/ISO standards relevant to Sterilization and Environmental monitoring
* To support specific projects as allocated by the Microbiology Team Leader
* All employees are responsible for minimizing both the Environmental and Health & Safety effects of the work that they perform
* To represent the Sterilization Assurance Department at Monthly QSR, Quarterly Quality Management Review
* Meetings and Technical Review Board Meeting, as delegated by the ISA Manager
* To validate gamma, Gas Plasma, EO, alternate sterilization processes for existing and new products to EN standards
* To create, review and approve Validation documentation as the Subject matter expert in Microbiology for Cleanline, clean room and Sterilization Validations
* To keep abreast of alternative sterilization technologies for the facility that could be applied to our clients products

Experience/Qualifications Required:



* High Attention to Detail Pro-active approach to Work
* High Standards
* Flexible
* Excellent Communication Skills Influencing Skills
* Strong Written & Oral communication skills and a team player
* High level of Numeracy Highly Computer Literate
* Planning & Organisation

Essential:



* Degree level qualification in Microbiology or equivalent. Minimum 5 years post qualification experience ( 5 years with BSc, 3 years with MSc and 0-2 years with PhD) as a Microbiologist in a medical device, pharmaceutical, or similar regulated industry
* Familiarity with microbiological aspects of GMP regarding sterile medical devices. Experience of conducting GMP audits, internal and relevant external audits
* Must have the initiative and ability to investigate, plan and execute those actions required to constantly improve and develop the company's microbial assurance levels
* An organized and logical approach to training, documentation, and audit requirements is also essential
* A professional approach, when dealing with internal, corporate, regulatory or supplier representatives is also required

Desirable:



* ISO 9001 Lead Assessor qualification

If this role is of interest to yourself, and matches your skills sets and experience then please click apply below to submit your CV. Please ensure your up to date contact details are on your CV before applying. If your application is shortlisted, we will call you and discuss the role in further detail to ensure this role is what you are looking for and meets our clients needs.

Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.

Candidates must be eligible to live and work in the UK.

For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.