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Closing Date: 17th July 2017
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Roche Singapore Technical Operations Pte Ltd
Head of Quality Technical Services

Purpose

  • Responsible for providing comprehensive technical support and QA oversight for Roche site Environmental Monitoring (EM) and Clean Utility Monitoring programs including data trending reports.
  • Ensure facility zoning concepts, EM monitoring locations, gowning programs and facility cleaning programs are performed in accordance with Roche site and global PQS requirements.
  • Ensure GMP area and equipment release programs in accordance with Roche site and PQS requirements.
  • Provide QA oversight of the Facilities department including FIT walk-throughs, calibration and preventative maintenance program and work order process oversight.
  • Responsible for Warehouse oversight, including product storage areas and cell bank storage areas, and QC oversight.
 
Key Responsibilities
 
Technical and Functional:
  • Ensure the EM and clean utility control strategies are robust and compliant in accordance with Roche site and PQS requirements.
  • Review and approval of site EM and clean utility trend reports.
  • Partner with Roche site cross-functional groups and global teams to drive improvements to the facility environment with a goal to reduce EM, clean utility and equipment excursions and adverse trends.
  • Own and manage facility and utility related DMS and lead EM and clean utility DMS RCA activities.
  • Provide QA oversight for QC labs, site media fill program and tank management program (as applicable by site).
  • Ensure programs/documents that Technical Services has oversight of supports a continuously compliant state at the assigned PT Site and a continual state of readiness for regulatory agency inspections.
  • Support regulatory inspections and partner audits.

Leadership and People Management:
  • Lead and manage all aspects of people processes - organization, staffing, talent management, performance management to meet strategic and operational objectives.  Direct staff in setting operational objectives and business goals for their respective areas of responsibility.
  • Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term.  Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.
  • As a leader within the Quality Assurance Operations team, drive network activities and alignment, cross-functional planning, and decision making.
  • Engage in proactive measures to promote a positive safety culture while ensuring all applicable Safety, Health and Environment requirements are fulfilled in alignment with corporate policy and local legal requirements.
  • Embody PT lean principles and methods while fostering a continuous improvement mindset throughout the organization by encouraging experimentation and learning.

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.

Qualifications

Education:
  • Bachelor's Degree (Pharmacy, Pharmaceutical, Bioengineering, Chemistry or other relevant area preferred. Depending on local law, in Europe: Pharmacist)
  • Graduate or higher-level Degree is preferred or as required by local regulations

Experience (may vary depending on site size/scope):
  • 7 or more years’ work experience in the pharmaceutical or related industry
  • 4 or more years’ people management experience
  • 3 or more years’ experience in licensed GMP facility

Knowledge/Skills/Competencies:
  • Expert knowledge of Quality System and QA principles, practices and standards for the pharmaceutical industry
  • Expert knowledge of cGMP relevant to the pharmaceutical industry
  • Strong knowledge of pharmaceutical, biotechnology or medical device related product operations including local and international quality regulations
  • Demonstrate excellent verbal and written communication skills in English
  • Employees with jobs that require access areas where product is stored must be able to pass Transportation Security Administration (TSA) and Security Threat Assessment (STA). (as applicable)

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





 
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