Nơi làm việc:
Hồ Chí Minh
Địa chỉ: TNR Tower, Level 4 & 5, 180 - 192 Nguyen Cong Tru, District 1, HCMC
Mức lương: Thỏa thuận
Chức vụ: Trưởng Nhóm
Kinh nghiệm: Chưa có kinh nghiệm
Hình thức làm việc:
Yêu cầu bằng cấp: Không yêu cầu
Yêu cầu giới tính: Không yêu cầu
Hồ Chí Minh
Mô tả công việc
• Ensure QA/QC team in charge of quality operation coordinates with relevant stakeholders for
- Regulation compliance check of incoming goods and make sure right status of received products.
- Verification of returned goods to make sure product quality as requirement of processes and clients
- Verification of irregular goods, quarantined/suspended stock, recalled products
- Perform and supervise all transaction on quarantined/ rejected stock
- Archiving QA/QC records related to products
- Verify, approve for results from operation activities (i.e. storage condition monitoring, pest control, device calibration)
• Give disposition to release/quarantine/reject products and redressing materials as Quality Manager’s instruction, PRN’s approval and relevant SOPs.
• In coordination with warehouse for redressing plan, arrange QA/QC team to ensure redressing activities are carried out in line with processes, PRN’s instruction and make sure product quality and current regulation/standard compliance as well.
• Support validation activities (i.e. mapping) by process witness, materials checking, data verification if requested.
• Ensure documentation control (i.e. SOP/WI distribution, training records, batch records) is properly managed.
• Revise SOP/WI related to assigned tasks
• Ensure change control/deviation documents related to site activities are verified and well documented
• Participate in quality incident investigation and drive/guide relevant teams to get right root cause & appropriate CAPA
• Participate and support audits, follow up post-audit if requested
• Notify quality deviation in timely manner to QA/QC Manager and PRN for any activities in quality scope if detected
• Supervise and arrange QA/QC team to monthly verify finished products to ensure products release to market meet quality requirements.
• Make monthly reports related to tasks following line manage request
• Participate in quality projects, supplier audits and internal audits
• Manage third parties in connection with redressing activities and incoming goods issues
• Back-up for the team in case of their annual leave or as requested
Yêu cầu công việc
• Pharmacist degree or bachelor degree in Biology/Chemistry as minimum requirement
• At least 3-year experience as QA/QC Supervisor in pharmaceutical industry
• Prefer experience in manufacturing site or redressing
• Experience with SAP, GMP, GSDP, ISO 9001, ISO 13485
• Good manipulation with Excel
• Good written and reading in English.
• Planning and organizational skills are necessary
• Detail-oriented, accurate and trustworthy
• Able to work in a fast-paced and deadline-driven environment