諾佛葛生技顧問股份有限公司
Lab Manager/Associate Director/Director_Large Molecule
10/11 Updated
Array
Full-time
Manager/Director
Partially Remote
0 ~ 5 applicants

Salary & Location

Salary negotiable
(Regular monthly salary of NT$40,000 or above)
台北市南港區

Required

Language Requirements
English
聽/精通、說/精通、讀/精通、寫/精通
Chinese
聽/精通、說/精通、讀/精通、寫/精通
Work Experience
5年以上

Job Description

Please do submit English resume to our company website.
https://fa-euzi-saasfaprod1.fa.ocs.oraclecloud.com:443/hcmUI/CandidateExperience/en/job/1488?utm_medium=jobboard
General Responsibilities:
Manage staff in accordance with organization's policies and applicable regulations, including without limitation: planning, assigning, and directing work; managing performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems; acting as a coach and mentor for subordinates as they develop in their role.
Participate in the selection and onboarding process for new staff by conducting candidate review and participating in the interviewing process. Conduct onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs.
Ensure that staff have the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable.
Maintain lab daily operation.
Ensure the quality and timely of lab deliverable.
Perform the tasks assigned by line manager.
Refer to additional GLP/GCP Regulation Required Responsibilities while involved in GLP organization.
As the member of test facility/site management.
Delegated /assigned as the system owner for computerized system, do the corresponding work for system, such as validation test, periodic review, report, etc.
GLP/GCP Regulations Required Responsibilities (if needed):
Lab Manager
Maintain an internal responsibility chart which identifies the individual(s) within a test facility who fulfil the responsibilities of management as defined by the Principles of Good Laboratory Practice.
Ensure that a sufficient number of qualified personnel, appropriate facilities, equipment, and materials are available for the timely and proper conduct of the study.
Ensure the maintenance of a record of the qualifications, training, experience and job description for each professional and technical individual.
Ensure that personnel clearly understand the functions they are to perform and, where necessary, provide training for these functions.
Ensure that for each study an individual with the appropriate qualifications, training, and experience is designated by the management as the Study Director before the study is initiated. Replacement of a Study Director should be done according to established procedures, and should be documented.
Ensure, in the event of a multi-site study, that, if needed, a Principal Investigator is designated, who is appropriately trained, qualified and experienced to supervise the delegated phase(s) of the study. Replacement of a Principal Investigator should be done according to established procedures, and should be documented.
Ensure documented approval of the study plan by the Study Director.
Ensure that the Study Director has made the approved study plan available to the Quality Assurance personnel.
Ensure the maintenance of a master schedule.
Ensure that test facility supplies meet requirements appropriate to their use in a study.
Ensure for a multi-site study that clear lines of communication exist between the Study Director, Principal Investigator(s), the Quality Assurance Programme(s) and study personnel.
Ensure that test and reference items are appropriately characterized.
Ensure that appropriate and technically valid Standard Operating Procedures are established and followed, and approve all original and revised Standard Operating Procedures.
If necessary, function as Study Director for specific study, in this case, he/she must not have the responsibility of test facility/site management role in the study.
Number of Openings
1~1人
Educational Requirements
大學(學院)以上
Work Schedule
日班
Leave Policy
依公司規定
Job Category
Other Health Professionals
Biotechnology Research and Development Staff
Novotech is internationally recognized as the leading regional full-service contract research organization (CRO) in Asia-Pacific providing clinical development services across all clinical trial phases and therapeutic areas, including an in-house and integrated global product development and regulatory affairs consultancy, BioDesk. Working in a fast paced and adaptable environment, we set a high benchmark for clinical trial operations by listening carefully, allocating Asia Pacific’s best people and talent, and leveraging best in class platforms, technology, systems and processes to meet our client’s clinical program goals and ultimately improve patient lives. Our people are critical in meeting organisational and client’s objectives and we place a strong emphasis on creating an inclusive, collaborative, transparent and collegiate work environment where everyone is supported to be the best they can be. We support our employees with financial assistance to enable flexible working arrangements, paid parental leave for primary and secondary carers, and regular training, learning, and international knowledge-sharing opportunities.
0 ~ 5 applicants