Company Name: PT. BIOTEK FARMASI INDONESIA
Location: Jakarta Raya
Posted Date: 09/10/2024 13:25
Salary:
Job Description
- Responsible for implementation of CPOTB requirement or other applicable requirement in day to day operations.
- Coordinates internal audit activities related with CPOTB including ensures availability and traceability documentation related with internal audit
- Ensure external audit preparation readiness related with CPOTB which conducted toward PT. Biotek Farmasi Indonesia including ensures availability and traceability documentation related with external audit
- Coordinates vendor audit activities
- Review technical and regulatory aspects of Master Batch Manufacturing Record (MBMR) and Master Batch Packaging Record (MBPR)
- Responsible to review total process as documented in both processing and packaging operation records, lab results, the environment record prior to release of the product, including for rework of the batch if any.
- Responsible to release finished product
- Review and approve related document for manufacturing, packaging, testing of product/material.
- Determine the disposition of any return goods which has been determined by policy to be a candidate for repacking and/or redistribution to market place.
- Responsible for compliance to all applicable regulations with regard to traditional medicine.
- Lead validation program
- Lead investigation for any deviation.
- Responsible for training and monitoring of CPOTB implementation