Head of Validation

Just Life Sciences
Swansea (Abertawe)
£40-£60k Dependent on experience
16 Jun 2017
25 Jun 2017
Just Life Sciences are an Independent Life Sciences Consultancy based in Cardiff,and are seeking a Head of Validation for a Bio Pharma business based in South Wales. This is a unique opportunity to be able to shape your role and add real value to the business, if you are looking for a role which offers more autonomy and greater scope then this is it. You will be responsible for all Validation Activities for the site and will also support otherfunctions such as Development , Quality, Logistics and Manufacturing , the Validation Manager will play a key role in supporting the expansion of the business's GMP manufacturing capacity, including the implementation of new manufacturing processes in its current site and the establishment of a GMP production facility at a new site. Specific activities will include the design and qualification of new manufacturing cleanrooms as well as the qualification of new manufacturing equipment including centrifugal, ultrafiltration and chromatography purification technologies in support of new manufacturing processes that will also undergo qualification in compliance with GMP. Maintenance of existing equipment / process qualification status in compliance with GMP. - (1) Duties and Responsibilities - To prepare and maintain a Site Validation Master Plan for the validation and revalidation of equipment, processes assays and computerized system in accordance with regulatory requirements. - To assist in design specification for the purchase of new equipment. - To be involved in factory acceptance testing of new equipment. - To write protocols and reports for Design, Installation, Operational and Performance Qualifications of Equipment. - To ensure the temperature monitoring of product distribution is appropriately validated and supported by protocols. - To determine acceptance criteria for validation studies. - To ensure that Assay Development is performed in accordance with current ICH guidelines. - To ensure appropriate process validation is carried out in accordance with ICH guidelines. - (2) Qualifications & Experience Required - Educated to degree level in a Scientific discipline supported by a minimum of 3 years' experience in a similar role within the pharmaceutical or allied industry. - (3) Principal Relationships - Reports to the Director of Quality - Has one direct report - Validation Technician - Interacts with Managers at all levels throughout the Company. If you have the relevant experience are looking for a broad and instrumental role then this is it. Please email justyn withey at justlifesciences dot com