- Puchong Selangor Malaysia
Working Location
Job Description
Responsibilities
1) Overall responsibility of fulfilling, assisting, managing production activities in meeting quality, productivity, targets, yield, cost and customer’s satisfaction.
2) Responsible for GMP issues on premise, cleanliness, quality of product and equipment.
3) To review all SOPs, Logbooks, Forms, Batch Manufacturing Record (BMR), Batch Packaging Record (BPR) are properly filled out on time in accordance to cGMP and GDP.
4) To assist with planning and coordination of production schedule and carry out training for production staff.
5) To raise and close deviation and change control when necessary.
6) To close audit findings closure in a timely manner.
7) To be responsible for data key in on SAP, TrackWise and Overall Equipment Efficiency (OEE) data key-in into the system on time.
8) To ensure the satisfactory level of compliance is maintained throughout critical sterile manufacturing processes and activities in accordance to cGMP standards.
9) To complete and evaluate the production records and ensure that they are signed by an authorised person before they are sent to the Quality Department.
10) To perform the necessary monitoring and control of the manufacturing environment, including Data collections, and data entries for trend studies.
11) Assist with coordination for any process validation, qualifications, calibrations, Aseptic Process Simulation on timely manner
12) To assist in preparing standard operating procedures and work instruction of manufacturing facility to ensure they meet current practices and policies
13) To assist in core support role and ensure all critical equipment in Production areas are well-maintained.
14) To enforce safety working practices to all staff and external visitors working in all areas of Production
15) To assist in equipment calibration master list for manufacturing facility
16) To ensure strict implementation of aseptic behaviors in clean room and overall workplace behavior in production at all times.
17) Responsible in ensuring the good level of compliance with documentation and maintain relevant records.
Job Type: Permanent
Pay: RM3,600.00 - RM7,200.00 per month
Benefits:
Application Question(s):
Education:
Experience:
Work Location: In person
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