106110 - QA Manager - Pharmaceuticals

Mô tả Công việc
- Location Address: Bien Hoa City, Dong Nai Province
- Monthly Salary: 40M-45M VND
Position Objective/Expectation:
- Drive a continuous Quality Assurance and Compliance improvement mindset 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, ...
- Lead the quality-related activities at the site to ensure safe, efficacious, and quality products can be supplied in accordance with regulatory and business requirements.
- Responsible for leadership and operational quality management.
Job Responsibilities
- Manage and supervise all activities related to product quality in the Company and ensure that these activities comply with WHO GMP, Com. GMP and regulation of the Ministry of Health of Vietnam.
- Coordinate with other managers to resolve problems that concern product quality.
- Co-ordinate the work of the Quality Assurance Department.
- Approve or reject intermediate products, the products are waiting for packaging and finished - product according to the Company's Policy.
- Review batch records and approve for release when ensuring that all product batches are manufactured in compliance with GMP regulations and meet the requirements of registration according to the Company's Policy.
- Review the Validation Master Plan and ensure implementation of validation/calibration, training, and self-inspection program.
- Organize or participate in annual GMP, GLP, and GSP self-inspections and prepare corrective action plans.
- Manage Quality Assurance operations to achieve annual departmental targets and budget. Prepare suitable objectives for QA staff and carry out annual performance appraisals.
- Take part in training GMP, Quality Management System.
- Take part in assessing the suppliers.
- Hold quality meetings frequently.
- Co-ordinate with RA Department to prepare registration documents according to RA's requirements.