Worawan Yamwong
About
Worawan Yamwong is from Bangkok, Bangkok City, Thailand. Worawan works in the following industries: "Pharmaceuticals". Worawan is currently Quality Assurance Manager at Siam Bioscience Co.,Ltd.. In Worawan's previous role as a Quality Management System Manager at Siam Bioscience Co.,Ltd , Worawan worked in until Feb 2018. Prior to joining Siam Bioscience Co.,Ltd , Worawan was a Senior Quality Assurance Associate (Indochina region) at Novartis(Thailand)Co.Ltd. ; Sandoz and held the position of Senior Quality Assurance Associate (Indochina region). Prior to that, Worawan was a Quality Management System Manager at General Hospital Products Public Co.,Ltd. from Jan 2011 to Jan 2013. Worawan started working as Quality Assurance Assistant Manager at Community Pharmacy Public Co.Ltd. in Jan 2008. From Jan 2005 to Jan 2008, Worawan was Quality Assurance Manager at Bangkoklab&Cosmetic Co.Ltd. Prior to that, Worawan was a Quality control pharmacist at OLIC (Thailand) Ltd. from Mar 1999 to Apr 2001.
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To take responsibility for ensure compliance of organization in responsible countries (Thailand, Myanmar, Cambodia) with legal and regulatory requirements as well as with the Novartis/Sandoz quality manual and policies. The activities are included as following : 1. Manage packaging artworks (Folding box, Label, Leaflet), product complaint handing , deviation management , change control management and risk assessment in critical situations. 2. Perform on-site product inspection before release to market to ensure that all drug products are complied with registered specification. 3. Ensure Quality agreement and product specific agreement are in place and updated for applicable manufacturing sites and service providers. 4. Perform proper quality training to commercial team and new employees. 5. Ensure that local quality system and standard operating procedures are in place and compliance with cGMP/GDP regulation is maintained through training and internal audits.
To take responsibility for the quality system implementation and monitoring of compliance in company to ensure that all working processes comply with regulatory requirement and quality standard. The process is included: 1. Manage product incidents/ customer complaints, corrective/preventive action for non-conforming incidents, quality risk management system, change control system and product quality review. 2. Perform strategic implementation to support new regulatory from Thai FDA. 3. Review and approve batch production record for final release of finished products. 4. Manage document control center to comply with GMP, ISO9001, ISO 13485 and ISO/IEC 17025 standard. 5. Conduct internal audit and external audits of raw materials manufacturer/supplier to ensure that the contractors comply with GHP and regulatory requirement. 6. Internal training “Quality system and requirement” to team and new employees.
To take responsible to manage all activities and support necessary resources for QA department which has three section ; Regulatory affairs section, Quality control section and Quality management section. The activities are included: 1. Monitor, measure and analyze working processes in QA department to ensure the operation and control are effective and accordance with Good manufacturing practices (GMP), Quality management system(ISO9001) and Good laboratory practice. 2. Review and approve product registration dossier or variation document, product stability protocol &result , batch production record for final release of finished products, SOPs and validation protocol &result. 3. Provide equipment, procedure and process to control and monitor product quality throughout process line of mixing, tablets compressing, capsule filling and finished good. Including the reprocess product, deviation and change control, raw material supplier audit to assure that all products which are manufactured have high quality and meet to finished product specification and FDA requirement.
1. Control and provide documents, equipment for support QA operation in QA department which has 3 sections. - Inspection section: Control and monitor product quality throughout process line of mixing, tablets compressing, capsule filling and finished good. - Calibration section: Calibrate instrument and equipment in company including provide calibration program and methods. - Analytical instruments center: Control, maintenance (IQ, OQ,PQ ), provide analytical instruments and equipment to support QC laboratory division including training program for operators. 2. Review and approve batch production record for final release of finished products, analytical instruction, manufacturing instruction, general instruction and validation protocol. 3. Monitor, measure and analyze working processes in QA department to ensure the operation and control are effective and accordance with Good manufacturing practices (GMP), Quality management system(ISO9001), Safety and occupational health management system (OHSAS 18001), Environment management system (ISO14001) and Analytical laboratory management system (ISO/IEC 17025). 4. Member in working teams of company such as Quality management committee, Non- compliance product committee, GMP and self-inspection committee and validation team.