Quality, Validation and Compliance Manager

A renowned chemical company is recruiting for a Quality, Validation and Compliance Manager job to ensure implementation of quality management systems and certification of GMP standards for the plant in line with the dynamic movement of the company and market requirements. This position reports to the GM, Quality Management.

About the Quality, Validation and Compliance Manager Role:
In this position, you will be oversee a plant upgrade project and set up all quality management systems and processes for the plant. You will also be expected to handle audits, acquire ISO certifications and achieve GMP-compliant standards upon the establishment of the plant.

Key Responsibilities:

• Set up the SOPs, quality management systems and processes within the quality department
• Ensure the product or service that the organisation provides is fit for purpose and meets or exceeds both external and internal requirements, including legal compliance and customer expectations and satisfaction
• Review, report and document all specifications related to new product, process, raw materials and packaging materials
• Conduct risk assessments for all project phases to ensure all mitigation and action plans are presented and closed prior to commercial run
• Ensure implementation of quality systems or improvements in line with dynamic movement of both company and market requirements
• Coordinate the activities required to meet quality and customers’ standards
• Establish and implement necessary communication action for the improvement and awareness of quality issues across all departments
• Act as the Quality Management Representative (QMR) to monitor and advise on the performance of the quality management system and processes through systematic analysis and audits
• Coordinate and participate in factory trial-runs and review trial protocols as per GMP requirements
• Total ownership of all quality improvement projects from initiation and brainchild, cross functional coordination, both internal and external and implementation of agreed projects, ensuring benefits and improvements are exacted on time and above targets, while maintaining high levels of quality, in terms of product, processes and systems

To succeed in this Quality, Validation and Compliance Manager role, you must have prior quality management, validation and compliance experience within the pharmaceutical manufacturing industry.

Key Requirements:

• Tertiary qualification in Pharmaceutical Science/Chemistry or relevant field of study
• Eight years’ experience in quality management within the pharmaceutical industry
• Having expertise in evaluation and performing GMP validation
• Prior experience in handling regulatory audits
• Strong familiarity in setting up Quality Management System (QMS)
• Familiarity with all the ISO systems and had been at least a representative in the committee
• Sound rationale thinking and application to resolving technical issues
• Good leadership skills with strong customer facing personality
• Strong analytical, problem solving and laboratory operation skills
• Team player and possess good interpersonal skills to collaborate effectively in cross functional teams

The company is a leading global chemical manufacturer that is well-known for providing innovative and high-quality products for customers worldwide.

If you are keen on an exciting and crucial opportunity, this Quality, Validation and Compliance Manager role is for you.

Apply today or send your CV to shanggar.marimutu@robertwalters.com.my to discuss this new opportunity.

Do note that we will only be in touch if your application is shortlisted.

Agensi Pekerjaan Robert Walters Sdn Bhd
(formerly known as Robert Walters Sdn Bhd)
Business Registration Number : 729828-T
Licence Number : JTKSM 423C