HOYA LAMPHUN LTD.

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Mar 14, 2025

Senior Manager Validation

สถานที่ปฏิบัติงาน

Mueang Lamphun, Lamphun

เงินเดือน

Based on company’s structure

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Job Descriptions

The Validation Senior Manager is responsible for overseeing a team dedicated to validation, ensuring all aspects of validation, testing, and documentation are completed in a timely and efficient manner. This role involves managing and coordinating validation projects, ensuring compliance with GMP regulations, and addressing regulatory issues. The Validation Senior Manager will also ensure that validation strategies are aligned with organizational goals and that quality systems are maintained throughout all processes and strategic activities. [1]Team Leadership: Lead and manage a team of validation engineers, providing guidance and support to ensure successful project outcomes. [2]System Development: Develop and maintain the team’s validation system to meet current regulatory requirements, internal global standards, and industry best practices. [3]Project Management: Oversee all aspects of validation projects, including changes to plants, equipment, processes, and automation/innovation initiatives, ensuring timely completion within budget and resource constraints. [4]Regulatory Compliance: Ensure the successful delivery of validation requirements for regulatory compliance projects in collaboration with the team. [5]Process understanding: Deep dive into process control studying typically involves gaining a comprehensive understanding. [6]Review and Coaching: Perform reviews of all validation work, providing coaching and support to sub-coordinators to ensure quality and accuracy. [7]Problem Solving and Performance Management: Proactively manage and resolve any constraints or performance issues, ensuring that business unit performance aligns with established targets. [8]Leadership and Direction: Provide clear leadership and direction to ensure business unit performance aligns with the Business Plan and Quality Management System, meeting all regulatory requirements and codes. [9]Additional Tasks: Perform additional tasks as assigned

Qualifications

Bachelor’s up to master’s degree in engineering, Science or Health (either industrial engineering, system engineering, chemical, food science, pharmaceutical).
Minimum 5 years of working experience in validated company, process control or improvement manufacturing.
Experience in medical device, strong knowledge of regulatory requirements and guidelines (ISO13585), including FDA and EU regulations are preferred
Math skills, analytical skills, teamwork, familiarity with Basic software and field specific software such as Minitab.
Experience managing projects and teams.
Strong communication and interpersonal skills
Good leadership, human relation, and accountability
Good in written communication and presentation skills.
Lean manufacturing experience with a continuous improvement mindset.
Process and detail oriented, including strong interpersonal and prioritization skills.
Highly motivated to work in a dynamic environment, with good integrity and character.
Ability to multi-task and organize work systematically in meeting deadlines without compromising
Good teamwork, well understanding of production and cleanroom environment control

BenefitsSee all Benefits.

How to apply

- Click Apply Now via JobThai.com - Apply by Email - Send Application by Mail **** Out of an abundance of caution due to the concerns surrounding the current situation with the Coronavirus (COVID-19), we will be conducting our hiring process completely virtually. That means that all interviews and onboarding activities will be held online or over the phone. The health of our employees and candidates is our main priority and we hope you will forgive any inconvenience that may arise from this non-conventional approach. While the day-to-day approach has changed a bit during this time, our commitment to hiring the best talent in the industry and helping them to thrive both personally and professionally is stronger than ever. ******

Contacts

Direk Pukdeejaturun

HOYA LAMPHUN LTD.

Tel. : 062-310-0626

Email : hoya_311@trustmail.jobthai.com (Email for job application & inquiry)

Fax : 053-552-217

Location

Ban Klang Mueang Lamphun Lamphun

Application Methods