บริษัท ไบโอแลป จำกัด

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Dec 26, 2024

Pharmaceutical QA Manager

สถานที่ปฏิบัติงาน

Mueang Samut Prakan, Samut Prakan

เงินเดือน

Negotiable

อัตรา

1 Position

สมัครงาน

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Job Descriptions

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 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 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 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

Bachelor's degree in pharmaceutical science.
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.
In-depth knowledge of regulatory requirements governing pharmaceutical manufacturing and quality assurance, including FDA, EMA, PMDA, PIC/s, and ISO 9001 guidelines.
Excellent problem-solving skills with a proactive approach to identifying and resolving quality-related issues, as well as implementing preventive measures to mitigate risks.
Experience in validation activities, including process validation, equipment qualification, and computer system validation.
Proficiency in document control processes and systems, with experience managing quality-related documents and records.
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.
Demonstrated ability to drive process improvements and implement best practices to enhance quality and compliance.

BenefitsSee all Benefits.

How to apply

- สมัครผ่านทาง JobThai - ส่งใบสมัครมาทาง E-Mail - ผู้ที่สนใจสามารถส่งจดหมายสมัครงานพร้อมแนบประวัติส่วนตัวและรูปถ่ายส่งมาตามที่อยู่ของบริษัท วงเล็บมุมซองว่าสมัครงาน - สมัครได้ด้วยตัวเองที่บริษัทฯ

Contacts

คุณวิรัลพัชร์ ผ่านนิเวศน์

บริษัท ไบโอแลป จำกัด

Tel. : 02-709-3121 ต่อ 1060

Email : biolab_169@trustmail.jobthai.com (Email for job application & inquiry)

Fax : 02-324-0080

Website : http://www.biolab.co.th

Location

Phraekkasa Mueang Samut Prakan Samut Prakan

Application Methods