Job Description
<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 cooperation with all relevant functions. The responsibility covers QA GMP activities: QA Infrastructure, Sterility Assurance, Quality Systems, and gives a release judgment. - 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. <Job Responsibilities> - Manage and supervise all activities related to product quality in the Company and ensure that these activities comply with WHO GMP and company GMP - Co-ordinate other managers to resolve problems that concern product quality. - Support to approve or reject intermediate products, the products are waiting for packaging and finished – product. - Review batch records, test records, and support to approve for release when ensuring that all product batches are manufactured in compliance with GMP regulations and meet the 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 - Organize or participate in annual GMP, GLP, and GSP self-inspections and prepare a corrective action plan - Manage Quality Assurance operation to achieve annual departmental target and budget. Prepare suitable objectives for QA staff and carry out annual performance appraisal - Take part in training GMP - Take part in assessing the suppliers - Hold quality meetings frequently
Job Requirement
<Necessary Skill / Experience > - Gender: Any - Age: 24 - 32 - Qualification: + Bachelor's Degree, major in Pharmacy + Must have the Pharmacist Practicing Certificate. - Experience: Have 2 years of working experience as a QA Staff in the Pharmaceutical field - Language: English - Business Level