Senior QC Specialist

To provide technical support to the projects team for Quality Control (QC) related activities for the new projects introduced in GSK Tuas Vaccines. He/she represents Tuas QC unit and collaborates with global/Belgium QC as well as global Manufacturing Science and Technology (MSAT) in all areas of QC validation and operation. The QC Specialist / Senior QC Specialist ensures that all aspects of QC testing of the new projects, test method validation, analytical equipment qualification, analytical method transfer, laboratory and analytical capacity are successfully completed. For new analytical test methods introduced, the QC Specialist / Senior QC Specialist ensures that the local QC unit participates in the method development and validation. He/ She will also support the local QC unit to be ready to transit into lifecycle management.

Responsibilities

Project Management

• Leads method validation, development, verification, transfer and new equipment / technology introduction. Performs testing for project related activities as required.
• Provides expertise and consultation to projects team on technical QC matters to ensure compliance to applicable corporate, regulatory and external agency regulations.
• Ensures 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.
• Works 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) and training plan
• Collaborates closely with global QC departments on test method innovation/ evaluation to support the project team in facility design / modification specifically for QC operations.
• Writes/ reviews change controls, events/ deviations, CAPAs and GMP documents (e.g. SOP, protocols, reports).
• Ensures spendings are within project target budget.
• Perform testing when required to adhere to test release and project plan
• Respects all safety and security polices, laboratory policies and practices on site and ensures policies and SEHSS are deployed and respected.

QC Operation

• Anticipate, plan and execute the transition from a project mode to routine mode in terms of QC operations.
• Knowledge management on knowledge retention and effective training to ensure methods/ knowledge are effectively transferred to routine testing team.

Why You?

Basic Qualification

We are seeking professionals with the following required skills and qualifications to help us achieve our goals

• Bachelor’s degree in chemistry, biochemistry, microbiology, life sciences or a related discipline.
• Minimum 4 to 6 years’ experience in a QC or analytical laboratory, preferably in pharmaceutical or life sciences settings.
• Practical knowledge of GMP principles and laboratory quality systems.
• Hands-on experience with analytical methods and laboratory investigations.
• Experience coordinating method validation, verification or transfer activities.
• Good written and verbal communication skills in English.

Preferred Qualification

If you have the following characteristics, it would be a plus

• Advanced degree (MSc) in a relevant scientific discipline.
• Experience with chemistry, biochemistry, environmental monitoring and water system testing.
• Experience with stability testing and stability data review processes.
• Familiarity with laboratory equipment qualification, calibration programs and computerized systems.
• Experience supporting regulatory inspections as a subject matter expert.
• Experience leading or coaching small teams and driving continuous improvement.

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Skills

Data Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Lean Management, Problem Solving, Quality Assurance (QA), Quality Control (QC), Risk Awareness, Testing Operations

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. We embrace an agile working culture across our roles, so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities, contact ***email_hidden***. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.

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