Assist the department head in streamlining departmental workflows.
Lead on-site rectifications to ensure the building fully complies with GMP requirements.
Draft on-site operational SOPs, ensuring their executability.
Conduct regular internal sharing sessions, training, and summarization.
Coordinate resources to ensure that validations such as temperature and humidity distribution, cleanliness, and computerized systems are executed as planned.
Design the end-to-end process from supplier delivery to workshop dispensing, resolving cross-departmental collaboration issues.
Lead the collection of WMS master data, process testing, permission configuration, and user support.
Design inspection routes, organize audits, and follow up on rectifications.
Assist in determining the initial organizational structure, clarifying reporting relationships and job responsibilities.
Train and develop subordinate employees to improve work skills and efficiency, ensuring team sustainability and resilience.
Identify operational risks and production issues within the team, follow up and resolve them promptly.
Oversee and ensure 100% execution of company-level training plans on-site.
Identify team members strengths and potentials, placing the right people in the right positions to build a complementary team.
Assist the head in setting team annual goals and summarizing annual performance.
Competencies:
Over 6 years of experience in CDMO industry.
Strong awareness of quality and compliance, familiar with operational documentation systems, understanding GMP production systems and documentation requirements, and a deep understanding of GMP, GDP, and data integrity requirements.
Familiar with project management and lean warehouse management tools.
Excellent communication and coordination skills, capable of effectively integrating internal and external resources to advance projects.
Outstanding execution and problem-solving skills, efficiently driving projects and coordinating cross-departmental resources.
Proven team-building and leadership skills, successfully forming and leading teams.
Ability to break down complex plans into simple actions on the front line and drive completion.
Training ability, actively summarizing and forming standardized documents and training employees.
Strong adaptability, quickly adjusting to new environments, and respecting cultural diversity.
Strong learning ability, quickly understanding and applying new cultures, equipment, and technologies.
Ability to professionally and appropriately represent the company in communications with external organizations.
Ability to maintain team morale under pressure and inspire members sense of responsibility.
