Mô tả công việc
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 công việc
+ 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 6 months 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
Thông tin liên hệ
- Người liên hệ: b.braun vietnam company ltd.
- Địa chỉ: