Sr Validation Specialist - Cold Chain

Careerwise Recruitment

Munster, Limerick

A Senior Validation Specialist (Cold Chain) is required by CareerWise Recruitment for our Limerick based multinational pharmaceutical client. A leading multinational with world-class opportunity currently has an opportunity to join their expanding team in Limerick. Our client has been consistently ranked a "Top Employer" amongst pharmaceutical companies worldwide. THE ROLE: Summary: Supervise a team of validations specialists in cold chain management whom are Responsible for the review and approval of Initial and Continuing validation and qualification documentation for QA Validation (Thermal mapping of CTU's/warehouse and shipping validation). Responsible for ensuring that systems and processes are qualified and/or validated in accordance with regulatory requirements and company manufacturing standards. Essential Duties and Responsibilities include, but are not limited to, the following: * Responsible for compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions. * Generates, executes and reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria. * May prepares equipment for qualification studies and executes qualification and validation studies according to approved protocols and SOPs. * Analyzes the results of testing and determines the acceptability of results against pre-determined criteria. * Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements. * Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions. * Reviews, edits and approves change control and SOPs. * Collaborates with functional departments to resolve issues. * May review, edit and approve HEPA certification reports, Automation performance evaluation reports, and other reports or documentation submitted to the department. * May train/advise less experienced Specialists and Technicians. * May supervise, provide direction and assign work to Validations Specialists and/or Technicians to meet goals and deadlines. * Assesses quality system documentation for completeness and accuracy, and dispositions documentation within SOPs. * Manages projects and prepares status reports. * Interacts with Automation/Process Engineering for managing changes during qualification window. * Strong communication/presentation skills during internal/external audits. REQUIREMENTS: * BS/BA in Engineering, Chemistry, or Life Sciences with 6 years of related experience within the field preferred; will substitute relevant experience for education. Please call Michael Hanrahan today for further information on 021-2019817 or email: mhanrahan@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent. This job originally appeared on RecruitIreland.com.

1964 days ago