# Subject Matter Expert, Manufacturing and Cleaning Processes

**Company**: GSK
**Experience**: senior
**Job type**: full-time
**Category**: Manufacturing
**Industry**: Healthcare

**Apply**: https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/Japan---Tochigi---Imaichi/XMLNAME----MSAT-Execution-_447912-5?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_7299dc7c-c52

## Description

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.

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.

- 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.

Basic Qualification:

- 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.

- At least 5 years of experience in pharmaceutical industries.

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

Preferred Qualification:

- 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

- Fluent spoken and written both Japanese and English.

*Legal right to work in Japan.

## Skills

### Required
- GMP/GDP
- good documentation practices
- cross-functional delivery
- risk/project management
- technical communication
- collaboration
- problem-solving
- critical thinking
- Japanese

### Nice to have
- technical manufacturing expertise
- English

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Source: [Apply at gsk.wd5.myworkdayjobs.com](https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/Japan---Tochigi---Imaichi/XMLNAME----MSAT-Execution-_447912-5?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)