QA Validation Associate is required for a Cork based Biopharmaceutical company. The site manufactures low volume bulk API for Phase III clinical trials, initial product launch and long term market support. The team on site grow, purify, formulate and bulk fill mammalian cell culture derived APIs for medicines intended for human use. The site is currently moving from commissioning into full scale commercial operations. This is an opportunity to work in a company that is innovative (ranked 10th most innovative by Forbes) and recognized globally as one of the fastest companies to get medicines to market.
This role offers you a chance to work in a state of the art facility, in an innovative Biotechnology company, with excellent career development opportunities and a clear and committed patient focus.
The QA Validation Associate will:
-Provide project management oversight for FUE activities related to the companys products and facilities, utilities, equipment (FUE).
-Developing validation plans for specific system implementation projects.
-Reviewing (project lifecycle documentation (URS, RA, Commissioning, Qualification Protocols)) validation activities related to the implementation of facilities, utilities, equipment changes while exercising judgment within broadly defined procedures and practices to establish approval criteria, and identify and implement solutions.
-Establish Site Validation Policies, through development, generation and implementation of validation master plans, guideline documents and SOP’s.
-Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured, validation techniques/approaches and systems utilized.
-Lead and represent Validation in multi-departmental meetings & project teams.
Qualifications and Experience:
-Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
-+5 years’ experience in a cGMP regulated manufacturing environment, with knowledge of equipment and utility validation, and laboratory systems / validation.
– Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
Call Mairead in LSC on 0214777 329 to discuss this QA Validation Associate role in more detail or apply directly via this advert