Documentation Engineer

  • Mức lương: Thỏa thuận

  • Thời hạn: Đã hết hạn

Ứng tuyển qua APP

Strong Understanding of Validations-Documenatation. Write/review/approve of protocols : URS; DQ; IQ; OQ; PQ protocols (this requires gaining an in-depth knowledge of the product to be able to determine what the necessary output is and if it is meeting predefined criteria).

Địa điểm làm việc:

35 Đại lộ Tự Do, VSIP 1, Thị xã Thuận An, Bình Dương, Việt Nam - (Bình Dương)

Ngành nghề:

Yêu cầu về bằng cấp (tối thiểu):

Đại Học

Tính chất công việc:

Toàn thời gian

Yêu cầu kinh nghiệm:

2 - 3 năm

Mô tả công việc:

- Strong Understanding of Validations-Documenatation.
- Write/review/approve of protocols : URS; DQ; IQ; OQ; PQ protocols (this requires gaining an in-depth knowledge of the product to be able to determine what the necessary output is and if it is meeting predefined criteria).
- Reports and make recommendations for changes and/or improvements and maintains appropriate validation documentation and files.
- Functions as a liaison with project engineering, manufacturing and the customer regarding validation.
- Coordinate, direct and lead validation including: 
* Process.
- Computer System Validation (CSV) including Electronic Records & Electronic Signature Assessments, Risk Assessment, Supplier Assessment
- Equipment and Instrumentation Qualification. 
- Facility and Utility Qualification.
- Testing of equipment
- Experience in GMP; EHS compliance; EU compliance; FAT; SAT.
- Documenting and reporting the analysis of test results
- Other duties as assigned.: Safety/Environmental
- Where applicable, individual is pre-planning safety into work activities to improve performance.
- Proactively identifies safety concerns.
- Complies with Environmental Management System program SOP’s, Policy & Program elements and encourages responsible use of resources.
- Completion of one of the following:
- Submission of a continuous improvement idea.
- Active participation in event.
- Attending meetings, writing reports to managers.
- Working independently with the inspector.
- Should perform activities relating to validation such as thermal studies, cleaning, equipment and utility validation.
- In order to execute protocol, they should often interact with the manufacturing sciences and other engineering departments.

Yêu cầu công việc:

* Project Management, Methods and Procedures, Process Improvement, Technical Understanding, Documentation Skills, Safety Management, Supervision
- GEP
- GMP
- Strong and diverse validation skills
- Qualifications - Education & Experience
- Integrity - Job requires being honest and ethical.
- Monitoring - Monitoring/Assessing performance of yourself, other individuals, or
- Coordination - Adjusting actions in relation to others' actions.
- Qualifications - Skills & Competencies
- Time Management - Managing one's own time and the time of others.
- Organizations to take corrective action.
- Cooperation - Job requires being pleasant with others on the job and displaying a good cooperative.
- B.S. degree in engineering field with 2+ years of related experience
- Ability to manage multiple large-scale documentations.
- Demonstrated superior communication, teamwork and organizational skills
- Working independently with the inspector. Ability to effectively present information and respond to questions from group of Auditors, Managers.
- Strong communication (verbal and written), teamwork and organizational skills

Quyền lợi được hưởng:

- Having chances to get attractive company bonus every month/year

- Company trip once a year + Joining party

- Salary and position is reviewed 1 time a year

- Bonus by individual ability and company’s performance.

- Social insurance, health insurance, unemployment insurance and other benefits

- Dynamic and sociable working environment.      

Công ty TNHH Dược Phẩm Glomed

200-500 nhân viên

35 Đại lộ Tự Do, Khu Công Nghiệp VSIP 1, TX. Thuận An, Bình Dương

Từ một công ty phân phối thuốc cho các hãng dược phẩm lớn trong nước và quốc tế, sau quá trình tìm hiểu, thâm nhập thị trường và đánh giá xu hướng ngành dược Việt Nam, Ban giám đốc Glomed qu... Xem thêm

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