Job Purpose:

The role serves as a subject matter expert responsible for validating, optimizing and maintaining robust manufacturing and cleaning processes to ensure consistent production of safe, effective and cost efficient products. This role provides technical expertise to drive process efficiency, compliance with regulatory and quality standards, and timely technical transfers and validations, while supporting investigations, continuous improvement and site readiness. Through strong cross functional collaboration and execution excellence, the role directly contributes to site supply reliability, product quality and overall business performance.

Key Responsibilities:

• Provide subject matter expertise for process validation, verification and lifecycle maintenance activities for manufacturing and cleaning processes.
• Plan, execute and document process and cleaning validation activities to ensure manufacturing capability and prevent cross contamination.
• Support Continued Process and Cleaning Verification (CPV/CV) through monitoring of critical process parameters to maintain process control and reduce variability.
• Execute process confirmations and periodic product reviews to support the Product Control Strategy and ongoing compliance.
• Analyze process data and trends to identify improvement opportunities and support product and process optimization projects.
• Support technical transfers, equipment or IM qualification activities, and related assessments to enable successful new product introductions and changes.
• Lead or support root cause investigations and change impact assessments, ensuring effective corrective actions, appropriate technical rationale and compliant documentation. Collaborate with Operations, Quality, Engineering and other MSAT SMEs to balance compliance, cost and supply risk and to support audits and regulatory expectations.
• Author, review and maintain technical documents, protocols, reports and assessments required to support validated state and effective knowledge management.
• Ensure the provisions of the employer regarding Health, Safety and Environment regulations in their area of competence, in accordance with EHS&S Corporate Standards; in particular ensuring proper use of personal protection equipment and applying the proper escalation process in case of any unforeseen risk, for the appropriate actions to be taken.

*Future scope of job and working location will be determined by company.

Basic Qualification

Skill

• Knowledge of GMP/GDP and good documentation practices, with experience supporting internal/external audits.
• Cross-functional delivery and risk/project management: Proven ability to work effectively across functions to coordinate technical activities, manage priorities and mitigate risk in a GMP manufacturing environment.
• Technical communication and collaboration: Ability to influence through expertise, communicate complex technical information clearly, and work effectively with Operations, Quality, Engineering and other stakeholders.
• Results-oriented mindset and continuous improvement: Committed to achieving business and quality objectives through data-driven decision making, innovation, and a focus on continuous improvement.
• Problem-solving and critical thinking: Ability to analyze complex situations, identify practical solutions, and make informed decisions based on data and metrics.

Experience

• At least 5 years of experience in pharmaceutical industries. 

Education/certification/Language

• Education: bachelor’s degree or equivalent in Scientific field (e.g. Pharmaceutical Chemistry and Technologies, Chemistry, Biology)

Preferred Qualification

Skill・Experience

• Technical manufacturing expertise: e.g. technical aspects of the Product Lifecycle including Scale Up, Technology Transfers, Technical Risk Assessments, Product Control Strategies, Process Capability/Robustness, QbD, Process/Cleaning validation, Contamination Control and change control

Education/certification/Language

• Fluent spoken and written both Japanese and English.

*Legal right to work in Japan.

Skills

CMC Strategy, Data-Driven Decision Making, Data Integrity, Debate Moderation, Digital Fluency, GxP Regulations, Lean Management, Problem Solving, Process Optimization, Project Leadership, Risk Awareness, Scientific Writing, Technology Transfer

 

 

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 APACRecruitment.Adjustments@gsk.com. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.

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