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The Position

Primary Purpose of Job (Job Summary)

Ensure quality & regulatory compliance of products manufactured in SRPL by effective management of Quality Control system functions in meeting business goal of company. Provide leadership for best practice such as GMP and GLP in Labs to compliance the current global standards.

General:

• Performance of microbiological testing of product stream samples (excipients bulk packaging materials and finished products) to meet product release timelines.
• Performance of environmental and critical utility testing in accordance with Chinese GMP EU GMP and cGMP regulations and Roche/Genentech standards.
• Performance of microbiological testing of stability samples to meet stability program requirements.
• Supporting manufacturing operations by timely completion of direct material sampling and ID testing.
• Continuous improvement of testing processes and technology in collaboration with ASAT to drive right first time and efficiencies.
• Qualification and validation of microbiological test methods.
• Supporting continuous improvement of manufacturing processes and technology in collaboration with MSAT by process validation and cleaning validation.
• Supporting investigations of microbial contamination in production processes classified environments and critical utility systems.

Principle Roles & Responsibilities / Accountabilities

Implement GMP compliance with global GMP standards and China GMP requirement

• Provide lab staff with technical guidance on test methods and relevant procedures.
  Ensure timely generation and reporting of test results in support of manufacturing operations.
• Ensure that data documentation and laboratory processes are in a constant state of regulatory compliance and inspection readiness.
• Ensure system computer change control and analytical data is reviewed evaluated and approved against established criteria.
• Ensure all laboratory operations including test execution review and data documentation follow cGMP procedures.
• Collaborate with Lab Support to ensure calibration and maintenance of laboratory equipment and systems.
• Collaborate with ASAT to ensure microbiological testing methods and specifications are in compliance with related pharmacopeias and regulations.
• Direct lab Staff in the timely resolution of issues including discrepancies investigations and implementation of CAPAs.
• Escalate any potential quality issues revealed during testing or processing of products especially quality or regulatory issues with the potential to affect product quality or regulatory compliance.
• Support regulatory inspections and partner audits.
• Provide QC technical support and oversight to CMO activities

• Approve protocols and reports (e.g. third-party QC labs MSAT or QC studies etc.).
• Build the collaboration with local government labs (xIFDC) and local health authorities to support Roche business in China
• Interface with Roche network in Microbiology (e.g. other sites global expert teams)
• Maintain the BSL-2 certificate and ensure lab operations and staff behaviors are in compliance with BSL-2 requirements.
• Manage the lab operation cost to meet the annual department budget

Leadership and People Management

• Lead and manage all aspects of people processes - organization staffing and 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 Control 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.

Qualification and Experience

Education/Qualifications

• Bachelors Degree((biology microbiology biochemistry chemistry or other relevant discipline is preferred)

• Graduate or higher-level Degree is preferred

Leadership Competencies

• 7 or more years work experience in the pharmaceutical or related industry

• 4 or more years people management experience

• 3 or more years quality compliance or other relevant experience in the pharmaceutical industry

Job Required Competencies

• Strong knowledge of analytical laboratory operations in support of commercial manufacturing.

• Expert knowledge of cGMP relevant to the pharmaceutical industry

• Expert knowledge of laboratory safety procedures

• Expert knowledge of Quality System principles practices and standards for the pharmaceutical industry

• Expert Knowledge in Pharmaceutical Microbiology

• Demonstrate excellent verbal and written communication skills in English

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.