Validation Manager
Pe Global
Kildare
Principal Responsibilities. Leading validation projects/activities such as media fills, process validation batches, re-qualification activities etc. Collaboration with Quality, Safety, Operations, Facilities and Engineering, Supply Chain and Regulatory Affairs. Process mapping and gap analysis. Project planning and execution including scheduling, task management, milestone planning and reporting. Delivering projects on time and on budget. Become Validation SME on site. Review of equipment specification/design/procurement/installation and validation. Generation, review and approval of project documentation (User Requirement Specifications, validation protocols, reports etc) and Standard Operating Procedures. Support validation activities for project activities including review of validation documentation. To facilitate and participate in meetings and workshops as part of Continuous Improvement activities. To approve plant SOPs and other documents as required, ensuring the acceptability of content and format. Working with the Validation Manager to define the validation approach associated with each piece of equipment, system, process and the requalification requirements including study requirements and frequency. Accountable for compliance via documentation completion, risk assessments, review of protocols and reports, closing out preventative and corrective action, participate in audits and inspections and proactively highlighting any issues around compliance. Supporting the execution of filter validation, polymeric contact material qualification, container closure integrity validation and Media Fills where required. Support and liaise with Technical Services in relation to the tech transfer of products into the facility. Supporting cleaning verification/validation and the execution of the cleaning verification and validation programs. Manage and perform data analysis and lead/support investigations as required and support the team to make informed decisions/recommendations around conclusions reached from data analysis, using appropriate methodologies as required. Responsible for authoring portions of regulatory submissions and defending the commissioning, design and qualification of GMP equipment to regulatory agency representatives during inspections. Work collaboratively to lead a safe and compliant culture. May be required to perform other duties as assigned. Qualifications. Commissioning, qualification and validation experience in Drug Substance/Fill Finish Manufacturing Facility (min 2 – 5 years. Experience in IMB/FDA environment advantageous. Strong technical writing and communication skills. Proven track record in RFT generation of validation/verification documentation. Problem solving and Project Management skills. Must be goal-oriented and able to prioritize and manage tasks. Education. Technical diploma or Degree in Engineering/Life Sciences or greater preferred. Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. This job originally appeared on RecruitIreland.com.
2023 days ago