諾佛葛生技顧問股份有限公司
Lab QA Manager（GLP/ISO17025）
9/18 Updated
Array
Full-time
Manager/Director
Partially Remote
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
Responsibilities:
1.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.
2.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.
3.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.
4.Monitor updates for regulatory legislations and/or guidelines.
5.Conduct review of documents, procedures, facilities… etc., to ensure compliance to the regulatory requirements.
6.Perform review and quality assurance for reports and documents to be submitted
to the regulatory departments.
7.Review the responses of the audit or inspection findings for appropriateness and completeness.
8.By following approved procedure and schedules, conducting audits either independently or collaboratively with other QA uditors.
9.Ensure timely completion of routine QA procedures.
10.Work collaboratively with each department head in the assessment of vendors' qualifications.
11.Assisting in project related or non-project related audits/inspections conducted by customer or regulatory authorities.
12.Write and issue audit reports or any non-conformances form in accordance with SOPs.
13.Ensure that audit findings are clearly made to the relevant project team members, department heads and upper management.
14.Participate in the investigation of non-compliance, problem reporting, or complaint issues. Follow through to verify corrective/preventive actions are appropriate and enforced as well as tracking and monitoring performances of the actions taken before case closed.
15.Perform housekeeping on documents generated as a result of QA activities.
Provide inputs to the development of departmental quality system process.
16.Manage SOPs according to company policy or regulatory agencies.
17.Conduct provisional tasks assigned by line manager.
18.Establish training plan for junior QA specialist and provide training to ensure compliance with company policy and regulatory requirements.
19.Perform the tasks assigned by line manager.
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
QA / QC Supervisor
台北市中山區
其他醫療保健服務業
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.
