Job Details
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Job Description
Description:
- Shall be overall in charge of QA, Regulatory Affairs and shall report to Plant manager. ·
- Shall review QA functions regularly and take necessary steps for improving the quality of the products, techniques and the implementations of cGMP for effective quality management.
- Is responsible for improving and strengthening the quality system and documentation requirements for cGMP.
- Responsible for monitoring all document controls including SOPs, annual product review, change control, deviation reports, investigation reports and CAPA
- Responsible for coordinating with production, QC and Maintenance for carrying out revision and approval of validation studies (e.g Process, cleaning), and equipment qualification.
- Responsible to prepare Site Master File (SMF) and quality manual.
- Responsible for issuing Batch Manufacturing Record and Batch Packaging Record.
- Responsible for monitoring and revision the IPC activity
- Responsible for all document controls including SOPs, change control, deviation reports, investigation reports and Regulatory Affairs
- Revision and Artwork verification on regulatory requirements
- Responsible for planning , carry out and supervision of internal audits or self-inspections
- Responsible for regulating, attending frequent visit of MOH inspectors
- Responsible for preparing, distributing BOM according to production plan
Job Requirements
Responsibilities:
- Excellent communication /expression and co- ordination skills to lead a team, to propose, suggest and to improve the Quality of the product and other techniques as per the expectation of management.
