QA Supervisor [ Biên Hòa - Đồng Nai ]

Mô Tả Công Việc
- Drive a continuous Quality Assurance and Compliance improvement mind-set within the Operations.
- Provide QA strategic leadership and project management of Quality Assurance ensuring compliance to applicable regulatory requirements and in co-operation with all relevant functions. The responsibility covers QA GMP activities: QA Infrastructure, Sterility Assurance, Quality Systems and give a release judgment.
- Lead the quality related activities at the site to ensure safe, efficacious and quality product can be supplied in accordance to regulatory and business requirements.
- Responsible for the leadership and operational quality management Manage and supervise all activities related to product quality in the Company and ensure that these activities comply with WHO GMP, OTSUKA GMP and regulation of the Ministry of Health of Vietnam.
- Approve or reject intermediate product, the products are waiting packaging and finished - product.
- Co-ordinate others manager to resolve problems that concern with product quality.
- Review batch records and approve for release when ensuring that all product batches are manufactured in compliance with GMP regulations and meet requirements of registered.
- Final review and approval of SOP for compliance with current GMPs.
- Review Validation Master Plan and ensure implementation of validation / calibration, training and self-inspection program.
- Manage Quality Assurance operation to achieve annual departmental target and budget. Prepare suitable objectives for QA staffs and carry annual performance appraisal.
- Organize or participate annual GMP, GLP, GSP self-inspections and prepare corrective action plan.
- Take part in training GMP.
- Hold quality meeting frequently.
- Take part in assessing the suppliers.