Sr. Validation Specialist
Company: Shire plc
Location: Georgia, United States
Posted: November 07, 2017
Reference ID: R0015486
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
Ensure validation master plans comply with Shire and regulatory agency requirements.
Develop process validation strategies and protocols for process changes.
Provide project management for process validation execution.
Support development of best demonstrated validation practices within the Engineering Validation Department, based on current industry practices and guidelines.
Support continuous improvement within the Engineering Validation Department.
Support regulatory submissions and regulatory agency inspections as required.
Represent Shire Engineering Validation Department to industry as required.
Serve on divisional teams as required.
Assist with preparation of regulatory filings, with answering questions from health authorities, and with presentations of materials during regulatory inspections/partner audits, as applicable and as related to the assigned programs.
Development and implementation of SOPs/Guideline documents with systemic procedural improvements related to process validation and associated activities. Determine methods and procedures on new assignments with oversight from project leadership team.
Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by Shire, validation techniques/approaches and systems utilized at Shire.
Identifies and implements improvements to the Engineering Validation systems (department level impact).