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Shire Process Validation Specialist in Lessines, Belgium
The Process Validation Specialist manages medium to big projects for Process and Cleaning Validation. He/She prepares and implements the validation documentation required to assure the proper development of a project and support regulatory submissions. He manages deviations and changes in order to guarantee that these are well documented and that corrective actions are taken and followed-up upon.
Contributing to continuous improvement and International standardization for topics related to process and cleaning validation,
Supporting small, mid size and big projects within the plant,
Assuring the ability to meet the Department goals in respect to Quality, Fullfilment and EHS
Take part in internal/external audits.
Coordinate activities of junior validation engineers and contractors
BS Degree or equivalent in Engineering, Chemistry, Life Science, or other job related discipline
Minimum 2 years in Validation/Quality Systems in a pharmaceutical industry
Project management experience
Excellent communication skills, fluent in English and French (written and spoken)
Familiar with Quality Management and GxP Regulations
Knowledge of Validation Methodologies
Knowledge of Quality Systems, European and FDA regulations, cGMP, GDP
Knowledge of the manufacturing processes
Requires excellent analytical skills with systematic approaches to problem solving.Must be able to break down complex problems and tasks into activities capable of being performed by personnel.
Sound industry knowledge, project proficiency, and autonomy expected. May be considered a Subject Matter Expert (SME) in various disciplines.
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, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda 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, a wholly-owned subsidiary of Takeda 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.
Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.