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Closing Date: 4th August 2017
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Roche Singapore Technical Operations Pte Ltd
Senior QC Specialist I

Key Responsibilities:

Drug Substance Release:
  • Perform Assay History Review (AHR) function for in-process and finished drug substances to ensure compliance with Roche SOPs and policies; assume the responsibility of the COA Approver and ensure timely lot disposition of the drug substances.

QC Operations Support:
  • Establish and maintain control limits for CQA and perform intra / inter-batch monitoring of CQA test results.
  • Participate in the preparation of the Annual Product Quality Review (APQR) QC sections.
  • Support the stability studies as a Stability Manager and /or site Quality Unit.
  • Ensure that the management of reference standards on site adhered to the global standard policy.  Support the qualification and retest date extension of reference standards where applicable. 
  • Participate in the development and execution of method monitoring assessment plans, which may also include the collections of monitored attribute data and retest information.

Discrepancy Management:
  • Proficient in the global standard policy on handling of non-compliance lab test results and able to provide guidance to the QC department on complying to these requirements.

Quality Oversight:
  • Provide Quality oversight of QC generated documents (e.g. SOP) and test data.

Compliance:
  • Provide technical assessments for Change Control.
  • Able to perform gap assessments and Local Impact Assessment for GSP implementations.
  • Participate in regulatory inspections as required.
  • Prepare training materials and conduct training where applicable.

Project Management:
  • Identify opportunities for continuous improvements.
  • Provide technical and project leadership over Analytical Method Transfer.

Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

Requirements:

  • Degree in a relevant Science field or equivalent.
  • 6 to 8 years of relevant work experience, preferably QC Laboratory / Quality Assurance, in a biotech or pharmaceutical industry.
  • Knowledgeable in GMP regulations.
  • Experience with statistical software tools such as Minitab, JMP desirable.
  • Demonstrate strong planning, organizational and technical analysis skills.
  • Possess an analytical mind and displays good level of problem solving ability.
  • Meticulous and attention to details.
  • Excellent written and oral communication skills.
  • Ability to work effectively with multi-function or multi-site teams and is a strong team player.
  • Capable of working independently. Able to multi task and resolve complex issues with minimal supervision.
  • Strong leadership and results driven.
Appointment to this position will be on local Singapore salary and benefits package.





 
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