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.