Senior Lab COE Specialist Job

Date: Jun 7, 2018

Location: Singapore, SG

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Requisition ID: QUA006434

Laboratory Center of Excellence (CoE) is a team of dedicated, energetic individuals who are committed to support the laboratory operation and drive optimization of productivity and efficiency within the Laboratories in our Manufacturing Division in Singapore. The team is responsible for driving continuous improvement and process harmonization and simplification within the laboratory. In addition, Laboratory CoE is also responsible for providing leadership in managing several key functional areas within the Quality Laboratory organization: Laboratory System including Data Integrity Program, Analytical Change Control, Supplier Qualification, Stability Program and Talent & Capability Development.




Reporting to Lab CoE Lead (Assoc. Director), this role has responsibility for supporting the laboratory system management, including system validation, System Development Life Cycle (SDLC) management, data integrity program and initiative deployment. The successful candidate will also be assigned to lead the Quality System Improvement Project (QSIP) to build and/or improve the site-wide Laboratory Data Integrity Management programs in accordance with initiatives driven by the Divisional QSIP. Work is primarily achieved through project teams and partnership with site sub-system owners (SSOs) and site subject matter experts. This role will require working cross functionally with Operations, Technology, and Quality.




Primary responsibilities may include, but not limited to:



  • Lead and drive Laboratory system validation in accordance to MSD SDLC requirements. Specific activities may include change control preparation, validation documentation, protocol execution and summary report.

  • Work together with and provide coaching to Junior Specialist to ensure system validation is completed in timely manner to meet business need.

  • Manage the life cycle of the lab system and instrumentation, including calibration and maintenance program.

  • Build and develop site laboratory Data Integrity (DI) program in alignment with Divisional Guidelines. Specific activities may include gap analysis, SOP development, Data Integrity program deployment and maintenance, and training.

  • Develop technical and innovative solution to mitigate and/or remediate any DI gaps identified.

  • Ensure inspection readiness within the lab in the aspect of lab system status and DI compliance. 

Qualifications


  • Education: A minimum of Bachelor Degree is required.

  • A minimum of 3 years in GMP Laboratory environment, Bio/Pharmaceutical Quality or Technical function supporting manufacturing/ laboratory operation.

  • In-depth knowledge and experience in system validation and Data Integrity compliance requirements are highly preferred.

  • Experience in project management and Quality improvement project is preferred.

  • Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment.



Job: Quality Lab Related
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 2
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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