Job Description

The Position

Purpose:

Supports the Department in the following:

Performance of testing to meet quality timelines and necessary trending analysis.

Performance of testing in accordance with cGMP regulations and Roche/Genentech standards.

Continuous improvement of processes and technology to drive right first time and efficiencies.

Ensuring test methods and data are generated in a compliant manner following cGMPs.

Key Responsibilities:

Technical and Functional:

Testing and review of routine and non-routine environmental, raw material, product related samples in accordance to the Standard Operating Procedures (SOP) and Test Methods (TM).

Testing, documentation and review of results in accordance with current Good Manufacturing Practices (cGMP) and Procedures.

Ensure timely completion of testing and reporting of test results in support of manufacturing operations.

General lab support including housekeeping, equipment maintenance, maintaining inventory of lab supplies.

Author and/or update existing SOP and TM as needed.

Train other analysts on methods and/or SOP.

Lead/ support in QC or cross functional projects: equipment qualification, method validation, method transfer, process improvement projects.

Lead/ support investigation and studies.

Problem solving of testing related issues as well as troubleshooting of equipment.

Initiator and/or lead for discrepancy and investigation record.

Perform assessment for lab related discrepancies and identify corrective actions where necessary.

Work closely with network SME and actively participate in cross functional meetings as and when required.

Responsible for ensuring that all training required to support/ perform GMP activities are completed timely.

Coaching of QC Specialists/ Technicians in the technical aspects of testing and cross functional projects.

Leadership:

Work co-operatively with the direct line supervisor to create an environment of strong team spirit, timely and effective communications. Strive towards team\xe2\x80\x99s objectives/goals, takes the initiative and proactively turn ideas into action \xe2\x80\x93 to make things happen.

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 behaviors, lean principles and methods while fostering a continuous improvement mindset throughout the organization by encouraging experimentation and learning.

A team player and the willingness to cover other shift colleagues in continued support of the In-Process Control operations.

Safety, Health & Environment:

Comply with all RSTO\xe2\x80\x99s Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.

Observe all RSTO\xe2\x80\x99s site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.

Lean Production System:

Embody PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviors through the use and application of LPS tools for continuous improvement initiatives.

Key Interfaces

Other QC functions

Manufacturing, Local MSAT

Quality Functions (e.g. QA Operations)

Other Site QC laboratories

Qualifications

Education:

Degree/ Diploma (biology, microbiology, biochemistry, chemistry or other relevant discipline is preferred.

5-7 or more years of relevant work experience preferably with laboratory hands-on experience in the pharmaceutical or related.

Knowledge/Skills/Competencies:

Strong knowledge of analytical, biochemistry and/or microbiology laboratory operations in support of commercial manufacturing.

Knowledge of cGMP relevant to the pharmaceutical industry.

Knowledge of laboratory safety procedures.

Knowledge of Quality System principles, practices and standards for the pharmaceutical industry.

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

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we\xe2\x80\x99ve become one of the world\xe2\x80\x99s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.

Roche