職位描述
Business Management Activities:
On-site supervision：
1. Supervise and inspect on-site operator’s operations conforming to SOP requirements, all behavior is consistent with the GMP requirements in production site, timely point out the non-conformance of production personnel and push them to improve.
2. Timely report abnormities / deviations of production process, lead production team for root cause analysis, develop and ensure the effective implementation of CAPA.
3. Check production records are true and complete.
4. Track and inspect all types of cleaning in production lines, and evaluate the cleaning effect.
5. Monitor the raw materials preparation process. Confirm and determine the quality problems of the raw materials in the production process, and timely feedback to QA department.
6. Handle quality problems happened in production process.
7. Audit production batch records and cleaning records.
8. Monitor GMP in production process, identify problems and timely propose and track improvements.
9. Track the execution of quality instructions, CAPA for abnormities, deviations and change, and confirm the effect.
Document control, training and quality statistics：
1. Assist supervisor to issue and update WI / SOP for cleaning and process quality control, train and audit the execution of WI and SOP.
2. Responsible for updating WI and form for A / B / C / D class cleaning.
3. Assist superiors to develop WI and record form for wet cleaning, train operators and assure successful completion of the wet cleaning project.
4. Develop the batch record form to constantly improve the process quality system.
5. Carefully audit the batch records and timely feedback to Production and Warehouse when problems found.
6. Assist to manage IPQA documents, ensure document’s validity and traceability.
7. Responsible for CAPA project in the effective implementation in Operations.
8. Assist the investigation of customer complaints, analysis the root causes and raise CAPA with Production and Maintenance, and track the implementation of CAPA.
9. Collect and statistically analysis various types of process quality data.
10. Organize to explore potential quality risk and take preventive measures.
11. Weekly summarize process quality and GMP audit result, and sum-up monthly.
12. Monthly statistics of Process RTFT%, and feed back to relevant personnel.
13. Responsible for the investigation of abnormities and deviations, monthly summarize and train three shifts of operators, and follow-up implementation of CAPA.
14. Continuously train, coach and improve the quality awareness of production operators in their daily job via GMP and SOP training.
15. Support to improve production efficiency, reduce production costs.
16. Update batch records / cleaning record / CCP record / production statistical track record, to ensure the effectiveness and feasibility, and compliance with SOP requirements; timely train production operators and make sure the daily execution compliance.
REQUIREMENTS
1. Educational Attainment Requirement Graduated from college above by subjects of Food and Nutrition Science / Biology / pharmacy, etc.
2. Professional background Experience: ? At least 3 years working experiences of process quality control in IMF industry
3. Expected Areas of Competence Technical know-how: ? Has manufacturing knowledge of food or pharmaceutical. ? With GMP and HACCP knowledge, problem analysis and solving skills. ? Good English writing skills and the ability to use office software. ? Good communication skills.
4. Managerial skills: ? Have a good cooperation, management and coordination skill.
5. Interpersonal skills: ? Easy to get along with people, good interpersonal.
