[Pharma] QA Manager _ KCN Amata

JOB PURPOSE: • 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 the 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 • Co-ordinate other managers to resolve problems that concern product quality • Co-ordinate the work of 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 requirements of registration according to the Company’s Policy • Review Validation Master Plan and ensure implementation of validation/calibration, training, and self-inspection program • Organize or participate in annual GMP, GLP, GSP self-inspections and prepare a corrective action plan • Manage Quality Assurance operations to achieve annual departmental targets and budget. Prepare suitable objectives for QA staffs and carry annual performance appraisal • Take part in training GMP, Quality Management System • Take part in assessing the suppliers • Hold quality meetings frequently • Co-ordinate with Regulatory Affairs Department to prepare registration documents according to RA’s requirements

KNOWLEDGE, SKILLS, AND EXPERIENCE: • Graduated in Pharmacy or relevant major • At least 05 years in the same position in Pharmaceutical Companies and suitable certificates • Good in English or Japan • Detailed knowledge and comprehensive understanding of relevant regulations, guidelines, and processes • Leadership experience with proven ability to influence and build relations • Comprehensive understanding of a wide range of Pharmaceutical Manufacturing and Quality Assurance Requirements • Have good management and leadership skill • Honestly • Have good time management • Could keep a team motivated • Critical thinking, decision making and problem-solving skills • Priority a candidate in Bien Hoa City