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.
Responsible for process monitoring of finished products
Responsible for process validation activities
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.
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).