Validation Engineer (Quality Engineer)
Mức lương: Thỏa thuận
Đã hết hạn nộp hồ sơ - 237 lượt xem
Ngày cập nhật: 02/07/2019
Thông Tin Tuyển Dụng
Mô tả công việc
Job Description:
To plan, conduct and follow-up validation exercises in accordance to B.Braun Validation SOPs, such as Design Qualification, Installation Qualification, Operation Qualification, Performance Qualification and Releasing Final Validation Report for all products produced in assigned production facility.
This includes to:
+ Be responsible to prepare the annual validation/calibration program for production processes/equipment used for producing and quality controlling at the plants of BBV VN
+ Strictly follow the annual validation/calibration program, and be responsible to prepare the validation/calibration plan. Coordinate with relevant department to implement validation/ calibration and prepare the report.
+ Coordinate with relevant department to assess the quality impact when having deviation in periodical validation/calibration.
+ Follow up create/revision of SOPs of relevant departments to align with validation result.
+ Plan and execute prospective validation to new products, new processes, new equipment, and other as request
+Prepare and/or revise the SOPs of QM related to validation.
+ Co-ordinate with relevant departments to undertake quality engineering projects with guidance from the Superior and the Management. To ensure that the validation and calibration activities are undertaken objectively based on clear technical aspects.
+ Prepare validation document to support drug registration activities (if any).
+ Assist other QM personnel for performing GMP audit, follow up the progress of overcoming the audit findings.
+ Participate in any project/ plan which involves Risk Assessment for project, product and process where applicable.
+ Provide training to relevant persons on validation procedure
+ Assists superior on CAPA management process, Risk management, Complaint Handling, Change Control process and other quality issues whenever required.
To plan, conduct and follow-up validation exercises in accordance to B.Braun Validation SOPs, such as Design Qualification, Installation Qualification, Operation Qualification, Performance Qualification and Releasing Final Validation Report for all products produced in assigned production facility.
This includes to:
+ Be responsible to prepare the annual validation/calibration program for production processes/equipment used for producing and quality controlling at the plants of BBV VN
+ Strictly follow the annual validation/calibration program, and be responsible to prepare the validation/calibration plan. Coordinate with relevant department to implement validation/ calibration and prepare the report.
+ Coordinate with relevant department to assess the quality impact when having deviation in periodical validation/calibration.
+ Follow up create/revision of SOPs of relevant departments to align with validation result.
+ Plan and execute prospective validation to new products, new processes, new equipment, and other as request
+Prepare and/or revise the SOPs of QM related to validation.
+ Co-ordinate with relevant departments to undertake quality engineering projects with guidance from the Superior and the Management. To ensure that the validation and calibration activities are undertaken objectively based on clear technical aspects.
+ Prepare validation document to support drug registration activities (if any).
+ Assist other QM personnel for performing GMP audit, follow up the progress of overcoming the audit findings.
+ Participate in any project/ plan which involves Risk Assessment for project, product and process where applicable.
+ Provide training to relevant persons on validation procedure
+ Assists superior on CAPA management process, Risk management, Complaint Handling, Change Control process and other quality issues whenever required.
Yêu cầu ứng viên
+ Graduated from universities with technical engineering background (Pharmacy, Chemistry or Biotechnology can be referred)
+ Good command of English both in communicating & writing
+ Have at least 1 year working experience in validation, calibration or equivalent.
+ Have working experience in pharmaceutical/ medical device manufacturing is an advantage.
+ Have knowledge GMP , GLP, GSP & Pharmacopeias
+ Able to use Auto Cad, Photoshop or other relevant software is a plus
+ Good command of English both in communicating & writing
+ Have at least 1 year working experience in validation, calibration or equivalent.
+ Have working experience in pharmaceutical/ medical device manufacturing is an advantage.
+ Have knowledge GMP , GLP, GSP & Pharmacopeias
+ Able to use Auto Cad, Photoshop or other relevant software is a plus
Quyền lợi được hưởng
- Compulsory insurance with an adding special health insurance
- International working environment with varity of training opportunities
- Breakfast & lunch free services
- International working environment with varity of training opportunities
- Breakfast & lunch free services
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Giới thiệu về công ty
B.BRAUN VIETNAM COMPANY LTD.
170 La Thanh, O Cho Dua Streets, Ha Noi
Người liên hệ: HR Recruitment Team
170 La Thanh, O Cho Dua Streets, Ha Noi
Người liên hệ: HR Recruitment Team
B. Braun Vietnam is one of the country’s top healthcare companies. It was established in Vietnam in 1992 and backed up by more than 175 years of experience in continuous pioneering and innovative breakthroughs worldwide. Together with its mother company B. Braun Melsungen A.G. and 64 subsidiaries worldwide, B. Braun ...Chi tiết
B. Braun Vietnam is one of the country’s top healthcare companies. It was established in Vietnam in 1992 and backed up by more than 175 years of experience in continuous pioneering and innovative breakthroughs worldwide. Together with its mother company B. Braun Melsungen A.G. and 64 subsidiaries worldwide, B. Braun has been providing world-class products and services to health care professionals. In the year 1990 B. Braun sold its first products in Vietnam via a Singapore exporter. These products consisted of IV solutions and medical disposables. It established the first Representative office in Ho Chi Minh City in 1992, followed by a representative office in Hanoi in 1993, then in Da Nang and Hue in the years after. In 1996, the construction of the first IV solutions factory was started and it was inaugurated in 1997. The factory had the first extension in 1999 and received its first GMP certificate. In 2008, the construction of the first B. Braun IV sets manufacturing plant in Hanoi, Vietnam was started. The factory was inaugurated in 2011 with the total investment of 32.6 Mio. EUR in the new IV set production facilities, making it the largest medical technology complex in Vietnam. B. Braun affirmed its commitment to invest further in Vietnam through the expansion of the current medical plant in Thanh Oai. The expansion includes a 35.5 Mio. EUR medical equipment factory of 8,500sqm, which was completed in the first quarter of 2015, raising the total investment for this plant to 71 Mio. EUR. Further expansion of the factory is planned to be in the beginning of 2017 with the additional investment of USD 100 million. Today, B. Braun Vietnam with a strong and driven sales force and service team, is one of the leading healthcare companies offering and pioneering in quality and cutting-edge health care products such as infusion solutions and devices, IV cannula, sutures, surgical instruments, diabetes care, out patient market products, value added drugs, regional anesthesia and clinical nutrition. Ẩn chi tiết
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Tìm thêm việc làm
B.BRAUN VIETNAM COMPANY LTD.
Địa chỉ: 170 La Thanh, O Cho Dua Streets, Ha Noi
Quy mô: 1.000-4.999 nhân viên
Việc làm tương tự
Validation Engineer (Quality Engineer)
Mức lương: Thỏa thuận | Hạn nộp hồ sơ: Đã hết hạn nộp hồ sơ