QA Specialist II

Roche Singapore Technical Operations Pte Ltd

Closing Date Closing Date: 17th July 2017

Roche Singapore Technical Operations Pte Ltd


Roche Singapore Technical Operations

Roche Singapore Technical Operations is Roche’s first biologics manufacturing site within Asia region, and the first company in Singapore to produce US FDA licensed bio therapeutics using recombinant DNA technologies. 

Our Vision and Mission


We will be the most admired biotechnology production operation, respected for our world class innovation, engrained quality inspired people and operational excellence.
Quality is every patient’s right and every employee’s responsibility. Quality provides a competitive advantage and is engrained in everything we do, from concept through continuous improvement. Because Roche’s products touch human lives, quality is the true measure of our success.
The Business of Improving Human Lives

With over 500 employees, two state-of-the-art facilities, using two different production technology platforms to manufacture bacterial and mammalian cell-based products – all within a 12.6 hectare biomedical space. Here is where we produce the biologic medicines that target a wide spectrum of patients and conditions.  Our facilities are designed for multi-product drug substance manufacturing based on CHO and E.Coli platforms. The 26,000 m² CHO facility manufactures Avastin, an anti-angiogenesis therapy for colorectal, lung, kidney, breast and brain cancer patients; and Herceptin, a therapeutic antibody for metastatic breast cancer.  The 3,084 m2 E.Coli facility, on the other hand, yields Lucentis, a treatment for patients with wet age-related macular degeneration, a leading cause of blindness in people over 55. The entire operation is supported by external infrastructure which includes a power substation, waste neutralization, industrial gases and water storage.
 

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.

Competencies:
  • 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
Requirements:
  • 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.