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/