Share this Job
Email similar jobs to meEmail similar jobs to me

Senior Lab COE Specialist Job

Date: Nov 16, 2017

Location: Singapore, SG

Company: MSD

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 Merck Manufacturing
Division (MMD) 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:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Laboratory, Pharmaceutical, Instrumentation, Editor, Project Manager, Science, Engineering, Publishing, Technology