QC Specialist / (Senior)

The Position

1) General

Department: Quality

Reports to: Head of QC Support Operations

2) Purpose

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.

3) Key Responsibilities

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.

Leadership:

• Work co-operatively with the QC Team Leader/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.

Safety, Health & Environment:

• 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.

• Observe all RSTO's 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

4) Qualifications

Education:

• Degree in Chemistry, Microbiology, Biochemistry, Life Science or equivalent

Experience (may vary depending on site size/scope):

• Minimum 5 years of related working experience for degree holders or equivalent holders with combination of education and relative work experience is preferred

• Related working experience in a biotech or pharmaceutical operating environment is preferred

• Experience in Lab computer systems e.g. CDS, LIMS will be advantageous

• Experience in Project Management

Knowledge/Skills/Competencies

• 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.

Who we are

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

Roche is an Equal Opportunity Employer.