Shire Validation Site lead in Woodlands, Singapore
The position holder is responsible for oversight and management of the Validation function for the Singapore manufacturing site and driving continuous improvement and standardization for Validation activities in scope.Global Validation is responsible for Validation of Equipment, GMP computer systems, Facilities, critical Utilities, lab equipment (non-bench top), as well asMaterial Qualification, Validation of Sterilization, Cleaning and Manufacturing Processes (PPQ).The job duties related to the site include, but are not limited to, the following areas:
provide strategic direction and leadership to the Validation organization at site
assure aligned resource management within the Department while taking into account internal User Requirements as well as Quality and GxP guidelines, building a team of Validation experts and maintaining an appropriate pool of contractors to support variable project needs to achieve Shire’s vision
Support small, mid size and big Projects within the Plant
develop employees and potential leaders within the Department
assuring the ability to meet the Department goals in respect to Finance, Quality, Fulfillment, EHS
Providing technical direction and guidance to Shire’s Validation specialists who work at the Site
Providing validation assessments to determine scope of validation needed in case of changes
Running the appropriate validation maintenance programs to ensure operations remain in a validated state to maintain product supply
Setting strategy for, reviewing and approving the validation portion of regulatory submissions
Deploying and maintaining new processes and systems resulting from new/revised regulation and guidance
Managing the Validation budget
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
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.