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TSMS Specialist (Elanco)

TSMS Specialist (Elanco)

Primary Function
  • Owns the validation knowledge of formulation process validation (e.g. Blending & Packaging), make sure the formulation process are in continued state of validation and continuously improving.
  • Ensures new validation concepts introduction and be followed well to maintain the site validation standard meet global level.
  • Owns the process knowledge of the product(s) assigned throughout the commercial lifecycle, maintains the oversight on process capability, through data trending and statistical analysis of critical parameters.

Primary Accountabilities/Responsibilities
  • Process validation
  • Responsible for process monitoring of finished products
  • Responsible for process validation activities
  • Routine
  • Establish & update technical documentation such as PFD, product control strategy, CQA…
  • Responsible for technical service on formulation process including deviation and complaint investigation, new product transfer, and new pack launch
  • Responsible for Formulation equipment cleaning assessment.
  • Participate in equipment qualification activities (e.g. IQ, OQ, PQ etc.)
  • Collaborate with technical development, other sites and global TS/MS network to facilitate transfer of technical knowledge.
  • Responsible to perform technical feasibility trials related to process improvement and implementation of new manufacturing technologies.
  • Support the Product quality report (PQR) (Data analysis, process monitoring& evaluation and etc.)
  • Support complete product transfer or new product launch within TS/MS technical scope.
  • Others
  • Owns the knowledge of specific pharmaceutical, chemical manufacturing engineering technologies, locally, including any support for URS writing, participating in investment projects, equipment function risk assessment reviewing and equipment qualifications.
  • Assures that the necessary benchmark is done internally in Elanco, and externally in the scientific and academic environment, in order to stimulate and to extend the knowledge, increasing the know-how of the associates and expanding it to the rest of the organization.
  • Support formulation product registration with other department.
  • Responsible for product lab&pilot trial, and accomplish the report.
  • Maintain their work in inspection readiness level and provide the necessary support in any internal or external audit in addition to providing input to and review regulatory documentation.
  • Provide the necessary training and education on related technologies if needed.
  • Be a recognized scientific expert internally and externally by reporting and presenting scientific/technical work at internal/external meetings/conferences and publish in peer reviewed international scientific journals including patents.
  • Support HSE with WHRA, ISO14000&18000 and other Compliance work.
  • BSc. in Pharmacy, Pharmaceutical Technology, Chemistry Engineering, or equivalent scientific degree.
  • Fluent in English and Mandarin
  • Minimum 3 years’ experience in GMP manufacturing relevant to the specialist area of expertise.
  • Proven process understanding (Pharma, GMP, Regulatory aspects).