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Lilly TSMS Specialist (Elanco) in 上海,

Job Category:

动物保健

Type of Employment:

全职员工

Responsibilities:

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.

Basic Qualificiations:

  • 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).

Additional Skills/Preferences:

Additional Information:

Company Overview:

Posted Date:

Keyword:

Region: 亚洲/太平洋地区

City: 上海

State: 上海市

Country: 中国

Location Details:

Req Id: 49809BR

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