Quality Assurance (pharmacist)
SIAM BIOSCIENCE CO., LTD
Thailand | Nonthaburi
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Last updated 1 month ago
SIAM BIOSCIENCE CO., LTD
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Quality Assurance (pharmacist)
SIAM BIOSCIENCE CO., LTD (Bang Yai)
Nonthaburi,
Thailand
Siam Bioscience focuses on research, development and manufacturing of biopharmaceuticals, pharmaceuticals, medical devices, and related healthcare products. The company conducts comprehensive R&D and manufacturing starting from active pharmaceutical ingredients and biological active substances to final dosage forms and finished products.
• Apexcela focuses on sales, marketing, and distribution of Siam Bioscience products, including business development aiming to build partnerships both in Thailand and worldwide.
Our main objective is to manufacture biopharmaceuticals using state-of-the-art and efficient technology. Biopharmaceuticals can treat many diseases effectively with low side effects. Our companies have started producing and commercializing biopharmaceuticals since 2016, launching erythropoietin for anemia and filgrastim for neutropenia. Our plant achieved PIC/s GMP, and ISO17025:2016. Our products are available through all reimbursement schemes in Thailand
Our world-class quality standards and comprehensive R&D coupled with business development capabilities have led us to be awarded contract development and manufacturing agreements of medicines and medical devices for various organizations, both in Thailand and worldwide.
In 2017, Siam Bioscience Group expanded business further by establishing 2 subsidiaries.
• Abinis Co., Ltd. is the joint venture company with CIMAB (Cuba) for R&D, manufacturing, and commercialization of mammalian cell culture derived biopharmaceuticals for treatment of various diseases such as cancer, autoimmune diseases, and anemia with focus on exportation.
• Inno Biocosmed Co., Ltd. is a wholly-owned subsidiary of Siam Bioscience for commercialization of biocosmeceuticals which are developed and manufactured by Siam Bioscience Group.
About this position
Responsibilities
• Maintain effective material and supplier qualification system in accordance with the GMP requirements.
• Establish, implement, maintain, and improve the material and supplier qualification system in accordance with the GMP requirements.
• Supplier audit
• Review and release batch manufacturing records, Batch packing records and QC results of company’s product.
• Review and evaluate environment monitoring data
• Prepare data for annual product quality review
• Execute according to procedure of Complaint, Recall and returned product.
• Effectively maintain QA procedures in compliance with GMP guideline, Customer and regulatory requirements.
• Co-ordinate with the responsible team to effectively implement quality management system.
• Co-ordinate with the system owner to assure that the qualification/validation have been implemented according to the protocols.
• Search necessary support quality information as assigned.
• Co-ordinate with the responsible team to implement quality management system to ensure that all QMS activities, e.g. change control, deviation, CAPA, audit, risk assessment, etc., are completed within timeframe and comply with the requirements.
• Assist and coordinate with relevant departments to perform the qualification and validation activities.
• Cooperate internal audit that are performed according to define plan.
• Perform related works as assigned.
Requirements
• Bachelor degree in Pharmaceutical Science
• At least 0 - 2 year experience in QA or related in pharmaceutical industry
• Knowledge of Quality System and GMP requirement
• English literacy and communication
• Good command in Ms Office and computer skills
• Have skill supplier qualification or quality management system will get the special consideration.
About SIAM BIOSCIENCE CO., LTD
Siam Bioscience focuses on research, development and manufacturing of biopharmaceuticals, pharmaceuticals, medical devices, and related healthcare products. The company conducts comprehensive R&D and manufacturing starting from active pharmaceutical ingredients and biological active substances to final dosage forms and finished products. • Apexcela focuses on sales, marketing, and distribution of Siam Bioscience products, including business development aiming to build partnerships both in Thailand and worldwide. Our main objective is to manufacture biopharmaceuticals using state-of-the-art and efficient technology. Biopharmaceuticals can treat many diseases effectively with low side effects. Our companies have started producing and commercializing biopharmaceuticals since 2016, launching erythropoietin for anemia and filgrastim for neutropenia. Our plant achieved PIC/s GMP, and ISO17025:2016. Our products are available through all reimbursement schemes in Thailand Our world-class quality standards and comprehensive R&D coupled with business development capabilities have led us to be awarded contract development and manufacturing agreements of medicines and medical devices for various organizations, both in Thailand and worldwide. In 2017, Siam Bioscience Group expanded business further by establishing 2 subsidiaries. • Abinis Co., Ltd. is the joint venture company with CIMAB (Cuba) for R&D, manufacturing, and commercialization of mammalian cell culture derived biopharmaceuticals for treatment of various diseases such as cancer, autoimmune diseases, and anemia with focus on exportation. • Inno Biocosmed Co., Ltd. is a wholly-owned subsidiary of Siam Bioscience for commercialization of biocosmeceuticals which are developed and manufactured by Siam Bioscience Group.