QMS Manager

Manage and maintain the Quality Management System (QMS) in compliance with PIC/S GMP, ISO 14001, ISO 13485 and applicable regulatory requirements. Develop and implement quality strategies and plans aligned with the organization’s annual and long-term business objectives. Review and approve Batch Manufacturing Records (BMR), Batch Packaging Records (BPR) and quality-related procedures and documents. Oversee key quality systems including Deviation, CAPA, Change Control, Validation, Stability, PQR and Quality Complaints . Review and approve validation protocols/reports and quality-related changes that may impact product quality. Manage Vendor/Supplier Qualification , Approved Vendor List (AVL), Contract Manufacturers and GMP-related outsourced activities. Ensure effective management of Internal and External Audits , including follow-up and corrective actions. Ensure proper storage, handling and distribution of materials and products throughout their shelf life. Liaise with regulatory authorities, certification bodies, customers and suppliers on quality and compliance matters. Promote quality awareness and continuous improvement across all departments. Monitor and report QMS performance, quality risks and improvement opportunities to top management. Act as the Authorized Person responsible for the release of APIs and finished products for sale . Qualifications: Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, or other related fields . Minimum 8–10 years of experience in Quality Assurance, Quality Management, or a related role in the pharmaceutical industry . Strong knowledge and practical experience in GMP/PIC/S, Quality Management System (QMS), and applicable regulatory requirements . Experience in batch release, deviation, CAPA, change control, validation, stability study, PQR, quality complaints, and audit management . Experience in managing supplier/vendor qualification, contract manufacturers, and GMP-related outsourced activities . Good knowledge of relevant regulatory standards such as Thai FDA, PIC/S GMP, ISO 13485, ISO 14001 , and other applicable regulations. Experience in working with regulatory authorities and certification bodies , such as Thai FDA and TGA, would be an advantage. Strong leadership, problem-solving, analytical and decision-making skills. Excellent communication and interpersonal skills with the ability to work effectively with cross-functional teams. Good command of English , both written and spoken. Experience or qualification as an Authorized Person (AP) for product release would be highly advantageous. If you are looking for a career opportunity, come and join us. Please submit your CV in English, current & expected salary via "Apply Now" Siam Bioscience Co., Ltd. (Head Office) 44 Srijulsup Tower, 18th Floor, Rama I Road, Rongmuang, Pathumwan, Bangkok (Factory) 99 Moo 4 Banmai, Bangyai, Nonthaburi https://www.siambioscience.com/