- Reference: JLS VM1
- Location: West Wales
- Salary: £45000 Negotiable
- Type: Full time
- Start: ASAP
Just Life Sciences, are the, specialist Life Sciences Recruitment Consultancy based in Cardiff, and are seeking a Validation Manager for their Pharma client, being a company which is saving lives Globally we are looking for two members of staff one is for a Permanent and the other is for a 12 month contractor, if you are looking for either and have the skills below then please get in touch.
Qualifications, Skills and Experience
- Just Life Sciences, are the, specialist Life Sciences Recruitment Consultancy based in Cardiff, and are seeking a Validation Manager for their Pharma client, being a company which is saving lives Globally we are looking for two members of staff one is for a Permanent and the other is for a 12 month contractor, if you are looking for either and have the skills below then please get in touch.
- Responsible for two members of staff,
- In addition to day-to-day validation activities to support all functions such as Development , Quality, Logistics and Manufacturing , the Validation Manager will play a key role in supporting the expansion of the GMP manufacturing capacity.
- The role will also be responsible for the implementation of a new manufacturing processes and managing the the establishment of the GMP production facility.
- 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.
- Reports to the Director of Quality
Has two direct report – Validation Technicians
Interacts with Managers at all levels throughout the Company.
- Have a sound knowledge of, and promote the Company’s Quality System.
A tremendous opportunity to be part of a Pharmaceutical business which is saving lives Globally
If you have the relevant experience and are seeking a new challenge within the Life Sciences Sector then please email your details to justyn withey at justlifesciences dot com
Just Life Sciences
< Back to jobs list