QA Validation Supervisor/Giám Sát Chất Lượng – Thẩm Định
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Mô tả công việc
Purpose of Position/ Mục đích của công việc
- To be designated the back-up contact for QA manager to manage all validation matters relating to all ZPV’s operations and oversights including pharmaceutical, healthcare products, medical devices...
- Supervise and instruct validation specialist and train to others in charge of validation activities to ensure proper implementation of quality standards/regulation and compliance with company processes/ regional QA guidelines, local regulation and international standards
- Assure all validation plan and execution are in compliance with regional quality assurance and relevant guidelines. Lead quality validation tasks inclusive of planning, protocol, report writing and prepare validation procedures (GxP-related systems such as temperature-controlled systems and computerized systems).
A. Supervise validation Plan/Giám soát kế hoạch thẩm định:
- Ensure smooth coordination of QA/QC team and other teams (such as operations, IT) to prepare annual validation plan and send to QA manager for approval.
- Oversight validation planning and execution to ensure all needed validations are done timely and properly.
- Conduct orientation training/ annual training/ update training for relevant staffs to validation procedures.
- Prepare monthly report for validation status and trending.
- Timely and properly maintain the documents in designated Sharepoint/ Document/Validation
- Yearly compiling and analysis of validation for management’s review. Prepare the risk assessment relating to validation management and work with relevant departments to mitigate the risk/ improve performance.
B. Execute Validation Activities / Thực hiện hoạt động thẩm định:
- Work in collaboration with assigned QA/QC team to witness the validation execution, check the validation reports’ data and prepare validation protocol and final validation reports.
- Check the periodic reviews relating to temperature-controlled system as validation plan.
- Check the periodic reviews/ audit trails relating to computerized systems as validation plan.
C. Handling audits/Tham gia các cuộc đánh giá:
- Participate in internal audit/ external (Clients and supplier) audit in scope of validation/ qualification related to GxPs. Request and monitor relevant CAPA execution (if any)
D. Handling other tasks/Quản lý các nhiệm vụ khác:
- Take part in the quality program (QA Competencies Certificate Program, individual development plan, TOP projects …)
- Monthly reports of the implementation of projects
- Cooperate with local operational execellence team to monitor and ensure the proper implementation of TOP projects
- Monthly and yearly compiling and analysis of the implementation of projects and near miss data trending
Yêu cầu ứng viên
- Education & Qualification:
Bachelor degree with background in pharmacy or natural science/ technology.
- Working Experience
- Two (2) years experience in quality control or quality assurance
- Knowledge or experience in the pharmaceutical industry.
- General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Validate processes and how they relate to regulatory requirements and cGMP regulations/ 21 CFR 21 part 11.
- Good communication skills, solving problem skills.
- Good in work organizing skills.
- Ability to work under high pressure.
- English fluency.
- Computer skills, good at MS office.
- Other Specific Requirements
- Detail-oriented, accurate and trustworthy
- Persistent and industrious.
- Able to work in a fast-paced and deadline-driven environment
Quyền lợi được hưởng
Competitive salary package with annual salary review and performance bonus
Health insurance, social and unemployment insurances as defined by Law
Annual vacation and Teambuilding
Annual Health Care
Dynamic environment, many challenges and development opportunities
A clear career path and promotion opportunities.
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THÔNG TIN TUYỂN DỤNG
VIỆC LÀM LIÊN QUAN
Hotline CSKH: (024) 7107 9799
0862 69 19 29
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