Job Description

Purpose

To provide technical support to the project team for Quality Control (QC) related activities for the new products introduced in GSK Tuas Vaccines in the area of method development/ qualification/ validation/ verification/transfer and equipment qualification.

Key Responsibilities Area

Project Management

Leads method validation, development, verification, transfer and new equipment / technology introduction.

Provides expertise and consultation to project team on technical QC matters to ensure compliance to applicable corporate, regulatory and external agency regulations.

Ensure timely implementation of the projects with full compliance to corporate, regulatory and external agency regulations if applicable.

Keeps up-to-date on regulations/ development of biopharmaceutical QC method/ technology to ensure the project maximizes the use of digitalization, automation and robotics.

Work closely with global/local QC stakeholders to develop and endorse the following:

Analytical transfer plan and Validation master plan

Cost management (eg. facility, analytical equipment)

Training plan

Laboratory expansion plan

Collaborates closely with global and Belgium QC departments on test method innovation/ evaluation to support the project team in facility design / laboratory expansion, specifically for QC operations.

Writes/ reviews change controls, events/ deviations, CAPAs and GMP documents (e.g. SOP, protocols, reports).

Identifies risks and challenges on QC matters for escalation and resolution.

Manage investigation of non-conformities (deviations and exceptions) and to review / approve SOPs / protocols / deviations / investigations / technical reports.

Ensure spendings are within project target budget.

QC Operations

Anticipate, plan and execute the transition from a project mode to routine mode in terms of QC operations.

Identifies the need for and scope of subsequent local QC representatives and supports their onboarding.

Support local QC management in areas of knowledge management and training for the new processes and testing requirements.

Skills, Knowledge & Experience

University degree in a relevant science discipline with at least 5 years of relevant working experience

Or diploma with at least 8 years of relevant working experience

Preferably with laboratory experience in pharmaceutical industry

Experience in leading QC method validation, development, verification, transfer

Laboratory equipment qualification and new technology introduction

Computer system validation for analytical equipment

Experience in QC testing (either QC Chem or Bio or both) for in process testing and product release (advantage)

Knowledge of cGLP & cGMP

Knowledge of compendium testing

Knowledge of statistics (advantage)

Effective report writing skills

Planning and organization skills

Good interpersonal and communication skills

Effective team player

Leadership skills

Analytical skills with logical thinking

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