Quality Assurance Manager (Pharmacist) - Biolab Co.,Ltd.
Biolab Co.,Ltd. · Samutprakarn
- Location
- Samutprakarn
- Salary
- Depend on qualifications and experience
- Job Type
- Full Time
- Work Type
- Onsite
- Education
- Bachelor's Degree or Higher
- Posted
- 22/05/2026
Responsibilities
1.Develop and implement quality assurance policies and procedures in accordance with regulatory standards, including PIC/s and ISO 9001 requirements.
2.Establish and maintain a comprehensive quality management system (QMS) to ensure compliance with all applicable regulations and guidelines.
3.Conduct thorough investigations into deviations and non-conformities, identifying root causes and implementing corrective and preventive actions (CAPA) to address underlying issues.
4.Collaborate closely with cross-functional teams to implement preventive measures and improve processes to minimize the occurrence of deviations and non-conformities.
5.Oversee validation activities for manufacturing processes, equipment, facilities, and computer systems, ensuring compliance with regulatory requirements and industry best practices.
6.Ensure the company is capable of undergoing audits by both customers and regulatory authorities, both domestically and internationally.
7.Manage document control processes, including the development, review, approval, distribution, and maintenance of quality-related documents and records.
8.Provide comprehensive training and ongoing guidance to personnel involved in manufacturing processes, ensuring their full awareness and understanding of quality assurance principles and practices.
9.Collaborate with cross-functional teams to resolve quality-related issues and implement preventive measures to mitigate risks.
10.Monitor key performance indicators (KPIs) to track and measure quality performance, implementing strategies to enhance product quality and safety.
11.Serve as a subject matter expert on quality assurance matters, providing guidance and support to internal stakeholders as needed.
Qualifications
1.Bachelor's degree in pharmaceutical science
2.Minimum of 8 years of progressive experience in quality assurance roles within the pharmaceutical or related industry, with a solid understanding of regulatory standards and requirements, including PIC/s and ISO 9001.
3.In-depth knowledge of regulatory requirements governing pharmaceutical manufacturing and quality assurance, including FDA, EMA, PMDA, PIC/s, and ISO 9001 guidelines.
4.Excellent problem-solving skills with a proactive approach to identifying and resolving quality-related issues, as well as implementing preventive measures to mitigate risks.
5.Experience in validation activities, including process validation, equipment qualification, and computer system validation.
6.Proficiency in document control processes and systems, with experience managing quality-related documents and records.
7.Strong leadership and managerial skills, with the ability to effectively lead and develop a high-performing team.
Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders at all levels.
8.Demonstrated ability to drive process improvements and implement best practices to enhance quality and compliance.
Benefits
- Provident Fund
- การตรวจสุขภาพประจำปี
- Staff training and development
- กิจกรรมกีฬาสี และกิจกรรมสันทนาการต่างๆ
- กิจกรรมท่องเที่ยวประจำปี
- Fuel/transportation fees
- ค่ารักษาพยาบาล 2 เท่าของเงินเดือน/ปี
- งานเลี้ยงสังสรรค์ปีใหม่
- ชุดยูนิฟอร์มปีละ 3 ชุด
- ซื้อสินค้าจากบริษัทในเครือได้ในราคาพนักงาน
- 5-day work week
- ปรับเงินประจำปี
- รถรับส่ง
- วันลาบวช จ่ายค่าแรงให้เท่ากับวันทำงานปกติ ไม่เกิน 15 วัน/ปี
- วันลาพิเศษเพื่อการสมรส วันลาพิเศษเพื่อการสอบในกรณีศึกษาต่อ
- วันหยุดประจำปี 15 วัน/ปี
- Employee's uniform
- เงินช่วยเหลือกรณี พนักงานคลอดบุตร/ สมรส /บิดา,มารดาเสียชีวิต
- เงินช่วยเหลือกรณี พนักงานเสียชีวิต
- Annual trip or party
- เบิกยาสวัสดิการกลับบ้าน
- Performance/results-based bonus
- Annual bonus
About Biolab Co.,Ltd.
BIOLAB CO., LTD. is the first modern ASEAN pharmaceutical manufacturer which has been accreditation for the ISO 9001 system. We are currently seeking determined personnel to join and work force. The company is interested in candidates who can work with us and develop work skills to an advanced professional level. This will enable us to strengthen our work team to provide even better customer services.
625 Moo 4 Bangpoo Industrial Estate, Soi 7A, Praksa, Muang, Samutrprakarn 10280
K.Viranphat Phanniwet
0-2709-3121 Ext.1063
Quality Assurance Manager (Pharmacist)Biolab Co.,Ltd.
Dream Company
Quality Assurance Manager (Pharmacist)
What you will do
Responsibilities
1.Develop and implement quality assurance policies and procedures in accordance with regulatory standards, including PIC/s and ISO 9001 requirements.
2.Establish and maintain a comprehensive quality management system (QMS) to ensure compliance with all applicable regulations and guidelines.
3.Conduct thorough investigations into deviations and non-conformities, identifying root causes and implementing corrective and preventive actions (CAPA) to address underlying issues.
4.Collaborate closely with cross-functional teams to implement preventive measures and improve processes to minimize the occurrence of deviations and non-conformities.
5.Oversee validation activities for manufacturing processes, equipment, facilities, and computer systems, ensuring compliance with regulatory requirements and industry best practices.
6.Ensure the company is capable of undergoing audits by both customers and regulatory authorities, both domestically and internationally.
7.Manage document control processes, including the development, review, approval, distribution, and maintenance of quality-related documents and records.
8.Provide comprehensive training and ongoing guidance to personnel involved in manufacturing processes, ensuring their full awareness and understanding of quality assurance principles and practices.
9.Collaborate with cross-functional teams to resolve quality-related issues and implement preventive measures to mitigate risks.
10.Monitor key performance indicators (KPIs) to track and measure quality performance, implementing strategies to enhance product quality and safety.
11.Serve as a subject matter expert on quality assurance matters, providing guidance and support to internal stakeholders as needed.
Qualifications
1.Bachelor's degree in pharmaceutical science
2.Minimum of 8 years of progressive experience in quality assurance roles within the pharmaceutical or related industry, with a solid understanding of regulatory standards and requirements, including PIC/s and ISO 9001.
3.In-depth knowledge of regulatory requirements governing pharmaceutical manufacturing and quality assurance, including FDA, EMA, PMDA, PIC/s, and ISO 9001 guidelines.
4.Excellent problem-solving skills with a proactive approach to identifying and resolving quality-related issues, as well as implementing preventive measures to mitigate risks.
5.Experience in validation activities, including process validation, equipment qualification, and computer system validation.
6.Proficiency in document control processes and systems, with experience managing quality-related documents and records.
7.Strong leadership and managerial skills, with the ability to effectively lead and develop a high-performing team.
Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders at all levels.
8.Demonstrated ability to drive process improvements and implement best practices to enhance quality and compliance.
Why you'll love working here
"Supportive community and opportunities for personal growth."
Employee ReviewsView All >
วิจัยและพัฒนา / วิทยาศาสตร์
>1 year, former
"แนะนำ ทุกวันนี้ก้ยังคิดถึง ถ้ามีโอกาศก้อยากกลับไป คิดถึงเพื่อนๆทุกคน เหนื่อยแต่สนุกมากๆ"
ดีWelfare
- Provident Fund
- การตรวจสุขภาพประจำปี
- Staff training and development
- กิจกรรมกีฬาสี และกิจกรรมสันทนาการต่างๆ
- กิจกรรมท่องเที่ยวประจำปี
- Fuel/transportation fees
- ค่ารักษาพยาบาล 2 เท่าของเงินเดือน/ปี
- งานเลี้ยงสังสรรค์ปีใหม่
- ชุดยูนิฟอร์มปีละ 3 ชุด
- ซื้อสินค้าจากบริษัทในเครือได้ในราคาพนักงาน
- 5-day work week
- ปรับเงินประจำปี
- รถรับส่ง
- วันลาบวช จ่ายค่าแรงให้เท่ากับวันทำงานปกติ ไม่เกิน 15 วัน/ปี
- วันลาพิเศษเพื่อการสมรส วันลาพิเศษเพื่อการสอบในกรณีศึกษาต่อ
- วันหยุดประจำปี 15 วัน/ปี
- Employee's uniform
- เงินช่วยเหลือกรณี พนักงานคลอดบุตร/ สมรส /บิดา,มารดาเสียชีวิต
- เงินช่วยเหลือกรณี พนักงานเสียชีวิต
- Annual trip or party
- เบิกยาสวัสดิการกลับบ้าน
- Performance/results-based bonus
- Annual bonus
About Company
BIOLAB CO., LTD. is the first modern ASEAN pharmaceutical manufacturer which has been accreditation for the ISO 9001 system. We are currently seeking determined personnel to join and work force. The company is interested in candidates who can work with us and develop work skills to an advanced professional level. This will enable us to strengthen our work team to provide even better customer services.
Location
625 Moo 4 Bangpoo Industrial Estate, Soi 7A, Praksa, Muang, Samutrprakarn 10280
Contact person
K.Viranphat Phanniwet
Telephone
0-2709-3121 Ext.1063
Website
www.biolab.co.th