- Entry level
- No Education
- Salary to negotiate
Responsible for the following:
Site Point of Contact (SPOC)/Business Process Owner for all QC Enterprise Systems that include LIMS, Empower, SoftmaxPro etc.
Project lead for QC Equipment and Computer Systems qualification/re-qualification, within schedule and according to the company policy.
Support or lead projects within QC functions, providing technical support with respect to QC equipment and Computer Systems.
Technical and Functional:
As part of the QC Support Operations Team to provide support for routine QC activities including:
Purchasing, qualification/re-qualification of laboratory equipment and computer systems
Perform Periodic Review of QC Equipment and Computer Systems
All other tactical support activities required to support the business needs
SPOC and Business Process Owner for LIMS, including Master data creation and changes
SPOC, coordinator and execution of any site upgrades for Global systems such as CDS and Softmax Pro.
Lead/execute projects which encompass QC equipment qualification, computer system validation and other QC systems related activities following cGMP requirements.
Perform data documentation and/or review for executed projects following cGMP procedures.
Ensure that data, documentation and laboratory processes are in a constant state of regulatory compliance and inspection readiness.
Timely resolution of issues, including raising discrepancies, investigations and implementation of CAPAs.
Support regulatory inspections and partner audits
Strong analytical skills to identify and remediate equipment qualification issues effectively and timely
Excellent knowledge of current 21 CFR Part 11 compliance and standards requirements
Conduct training on LIMS, CDS, CSV and LEQ related topics
Embody PT lean principles and methods while fostering a continuous improvement mindset throughout the organization by encouraging experimentation and learning.
Work co-operatively with the Snr QC Supervisor/Head of QC Support Operations to create an environment of strong team spirit, timely and effective communications.
Strive towards team’s objectives/goals, takes the initiative and proactively turn ideas into action – 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 colleagues in continued support of the QC Support operations.
Comply with all RSTO’s 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.
Other QC functions
Quality Engineering Validation
QC Network- GQC
Bachelor’s Degree (Chemistry, Microbiology, Biochemistry or any Life Science related is preferred
Experience (may vary depending on site size/scope):
2 to 5 years’ work experience in the pharmaceutical or related industry
Experience in validation of Lab computer systems (e.g. CDS, LIMS, etc.) and administrative roles is preferred
Knowledge on Lean Production System
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
Strong problem solving capability. Able to determine when to escalate issue.
Ability to organize and plan effectively. Effective resource management.
Demonstrate good verbal and written communication skills in English.
Appointment to this position will be on local Singapore salary and benefits package.
About the company
Roche is a Swiss global health-care company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange.
The company headquarters are located in Basel and the company has many pharmaceutical and diagnostic sites around the world – including: Tucson, AZ; Pleasanton, CA; Vacaville, California, Oceanside, California, Branchburg, NJ; Indianapolis, Indiana; Florence, South Carolina; and Ponce, Puerto Rico in the US; Welwyn Garden City and Burgess Hill in the UK; Clarecastle in Ireland; Mannheim and Penzberg in Germany; Mississauga and Laval in Canada; Shanghai in China; Mumbai & Hyderabad in India; São Paulo and Rio de Janeiro, Brazil; Segrate, Milan in Italy; Johannesburg in South Africa; Karachi, Islamabad and Lahore in Pakistan. There are 26 manufacturing sites worldwide.