Validation Specialist - Sterilisation

Location
Greater London
Salary
D.O.E.
Posted
08 May 2018
Closes
05 Jun 2018
Ref
J5379
Contact
Sariat Adeniji
Contract Type
Permanent
Hours
Full Time
We are currently looking for a Validation Specialist - Sterilisation to join a leading company based in the Hertfordshire area. As the Validation Specialist - Sterilisation you will be responsible for ensuring compliance with all applicable (EHS and GxP) regulatory and internal Quality standards and industry best practice. You will need to be committed to, and passionate about providing a reliable and compliant service to meet and exceed the customer's needs. This is a customer-facing role, and as such the ability to form relationships across the organisation is essential for success.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Validation Specialist - Sterilisation will be varied however the key duties and responsibilities are as follows:

1. You will ensure requirements of EN28 and its practical application when validating porous load sterilisers.

2. You will support the implementation validation strategies that allow the work to be executed by the most appropriate personnel (internal and external) whilst maintaining standards.

3. You will highlight risks to product quality, patient safety and/or data integrity throughout the validation lifecycle so that they are understood, transparent and can be managed through the application of a quality risk management approach.

4. You will be responsible for the ongoing compliance of all assets at the facility within your remit, ensuring that the equipment meets regulatory requirements at all times with a target of zero impact to routine operations.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Validation Specialist - Sterilisation we are looking to identify the following on your profile and past history:

1. Relevant degree in a science or engineering related discipline or similar related qualification.

2. Proven industry experience of validation within a bio-pharmaceutical or sterile manufacturing environment (API and/or fill/finish).

3. A working knowledge and practical experience with application of risk and science based tools to drive execution strategies and support issue resolution.

Key Words: Sterilisation | Validation | Manufacturing | Aseptic | Bio-Pharmaceutical | API | Depryogenation | IQ | OQ PQ | Documentation |

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.

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