Responsibilities
● Be responsible for coordinating department compliance, training, and document control for both GMP and non-GMP systems.
● Compliance tasks include: scheduling daily compliance meetings, following up on audit findings, leveraging best practices from other sites on audit procedures, achieving audit documentation, and conducting lessons learned, etc.
● Training coordination includes: tracking team members' training programs, setting up training modules for each SEM group in accordance with SOPs, scheduling regular training classes for the team, archiving training records, and coordinating with the QA training team on any issues.
● Participate in projects to develop training plans according to the operation readiness schedule.
● Manage general contractors and subcontractors regarding turnover package submission.
● Timely coordination with the SEM team and external teams to ensure all related work is completed on time.
● Act as the training coordinator to manage all SEM members' training records.
● Assist in drafting or updating SOPs, URS, or other necessary documents.
● Perform other tasks as assigned by leadership.
Requirements
● Diploma or higher qualification in human resource, public management, Pharmaceutical Engineering, or other related specialties; candidates with equivalent work experience is plus.
● Ability to quickly learn GMP related knowledge and all related calibration requirement and code.
● Possess good communication ability and comprehension ability.
● Display a good working attitude, strong work ethic, and willingness to follow leadership directives.
● Be open to accepting temporary work assignments, including overtime on weekends or weekdays, and other roles as required.
● Able to work independently with limited supervision in a fast-paced environment.
● Possess good multi-tasking and prioritization skills.
Career development
● Through complete systematic training, you will quickly grow to be a compliance/document control engineer and a subject matter expert of related work.
● A performance-oriented promotion system, diverse and comprehensive challenges in a cGMP manufacturing environment, and career advancement incentives will all contribute to your career development.
● Explore your management potential, grow with the team, and light up the growth plan of life.
