1 Pharmaceutical Manager jobs in Thailand
Pharmaceutical QA Manager
฿1200000 - ฿2400000 Y
Biolab Co., Ltd.
Posted today
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Job Description
Responsibilities:
- Develop and implement quality assurance policies and procedures in accordance with regulatory standards, including PIC/s and ISO 9001 requirements.
- Establish and maintain a comprehensive quality management system (QMS) to ensure compliance with all applicable regulations and guidelines.
- Conduct thorough investigations into deviations and non-conformities, identifying root causes and implementing corrective and preventive actions (CAPA) to address underlying issues.
- Collaborate closely with cross-functional teams to implement preventive measures and improve processes to minimize the occurrence of deviations and non-conformities.
- Oversee validation activities for manufacturing processes, equipment, facilities, and computer systems, ensuring compliance with regulatory requirements and industry best practices.
- Ensure the company is capable of undergoing audits by both customers and regulatory authorities, both domestically and internationally.
- Manage document control processes, including the development, review, approval, distribution, and maintenance of quality-related documents and records.
- Provide comprehensive training and ongoing guidance to personnel involved in manufacturing processes, ensuring their full awareness and understanding of quality assurance principles and practices.
- Collaborate with cross-functional teams to resolve quality-related issues and implement preventive measures to mitigate risks.
- Monitor key performance indicators (KPIs) to track and measure quality performance, implementing strategies to enhance product quality and safety.
- Serve as a subject matter expert on quality assurance matters, providing guidance and support to internal stakeholders as needed.
Qualification:
- 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.
Employee Benefits
- Comprehensive Medical Coverage
- Annual Health Check-ups
- Provident Fund
- Uniform Allowance
- Company Shuttle Service
- Annual Bonus
- Annual Salary Increment
- Performance-Based Incentives: Monthly increments
- Overtime Pay
- Shift Allowance
- Prescription Reimbursement
- Employee Purchase Program
- Group Purchase Program
- Annual Company Trip
- Sports and Recreational Activities
- New Year Party
- Death Benefits
- Family Assistance: Financial support for births, marriages, or deaths of immediate family members
- Special Leaves
- Ordination Leave
- Annual Leave
- Birthday Celebrations
Biolab Co., Ltd.
625 Moo4 BangPoo Industrial Estate,
Soi 7A, Praksa, Muang,
Samutrprakarn 10280, Thailand
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