Job Summary:
Supervisor of Technical Services Department, responsible for supporting new project evaluation, product transfering, production process validation, the operation and maintenance of process and improvement of manufacturing process.
Responsibilities:
- Coordinate and ensure timely execution of Validation Master Plan activities, including process performance qualification, aseptic process simulation, and related validation tasks, while maintaining compliance with regulatory requirements.
- Assist in client communication, technology transfer documents preparation, batch execution and project tracking activities to meet project milestones and address real-time changes.
- Support the development and implementation of effective site procedures for qualification, validation, technology transfer, and process improvements in alignment with industry standards and company policies.
- Set performance metrics for the technical service team, monitor progress against objectives, and report updates to management.
- Collaborate with the technical team to identify and implement solutions for technical issues and recommend process improvements based on experimental results, regulatory standards, and business goals.
- Conduct investigations into deviations or technical issues in commercial production and provide technical guidance to resolve root causes effectively.
- Organize and deliver formal and informal training sessions for team members to ensure continuous development and compliance with regulatory expectations.
- Assist in preparing budgets and resource plans for technical service activities and ensure alignment with department goals.
Qualifications:
- Bachelor's degree in Pharmacy, Chemical Engineering, Biotechnology or related science discipline and over 3 years of related experience.
- Technical writing skills of GMP documents.
- Proven track record of process development, process optimization, and technology transfer experience.
- Ability to work with cross functional teams and meet performance commitments.
- Speaking and writing skills in both English and Mandarin.
