Closing Date: 17th July 2017

Roche Singapore Technical Operations Pte Ltd
QA Specialist II

Key Responsibilities

  • Provide Quality Assurance (QA) oversight in Manufacturing operations to ensure that the manufacture of product and maintenance of the facilities are in compliance with SOPs, policies and cGMP / GDP guidelines
  • Review batch production records and associated documents to ensure compliance with SOPs and policies
  • Manage discrepancy management system to ensure that deviations are appropriately assessed and reviewed to ensure compliance with SOPs and policies
  • Participate in the assessment, review and approval of change controls and corrective / preventative actions
  • Participate in the development and / or review of related SOPs and policies to support batch production and product release
  • Train junior members of the team and ensure they are equipped to execute MQA tasks
  • Prepare training materials and conduct training on MQA-related procedures and processes as required
  • Perform assigned tasks while meeting timelines to achieve company goals and department objectives

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.

  • Seasoned professional who displays solid understanding of technical processes
  • Recognized as source of expertise with sound knowledge of operational quality processes and cGMP skills
  • Ability to make sound decisions on process events based on company’s policies and defined quality standards
  • Displays good level of conceptual thinking skills and applies simple concepts to look at situations from different angles
  • Ability to develop and support peers in building technical expertise in own / cross functional areas
  • Ability to prioritise, plan and manage deliverables effectively
  • A proactive team player with good demonstration of leadership skills
  • Bachelor’s degree in a relevant science discipline with minimum of 3 years of relevant experience in the pharmaceutical industry
  • Sound knowledge of cGMP guidelines or equivalent regulations
  • Meticulous, systematic and of an analytical mind
  • Able to make sound decisions and demonstrate ability in managing priorities
  • Strong communication skills demonstrated both in writing and verbally
  • Flexible in work hours to meet business objectives
  • Proven ability to work well under pressure

Appointment to this position will be on local Singapore salary and benefits package.

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