Officer - Quality Assurance (Validation)

Ranbaxy (Malaysia) Sdn Bhd a SUN PHARMA company; Sungai Petani; On-site; MYR 67,000 - 112,000; Full time

Benefits offered by this job

Competitive pay

Health & medical benefits

Career development

Supportive work environment

Job summary

Ranbaxy (Malaysia) Sdn Bhd, a SUN PHARMA company, is seeking an Officer – Quality Assurance (Validation) to join our pharmaceutical manufacturing facility in Sungai Petani, Kedah. This full-time role focuses on executing and maintaining validation programs to ensure GMP compliance and quality across equipment qualification, process validation, cleaning validation, and related documentation.

You will collaborate with cross-functional teams to sustain audit readiness, maintain SOPs, and support

Qualifications

• Bachelor's degree in Science, Manufacturing, or Pharmaceutical studies.
• Understanding of pharmaceutical manufacturing or production processes.
• Strong organizational and time management skills.
• Excellent communication in English and Bahasa Malaysia.
• Proficiency with MS Office and data management systems.
• Attention to detail and commitment to high quality.
• Ability to work collaboratively in a team and follow instructions.
• Knowledge of lean manufacturing or continuous improvement is advantageous.

Responsibilities

• Execute qualification, validation, and cleaning validation per VMP and cGMP.
• Prepare, review, and maintain qualification/validation protocols and reports (DQ/IQ/OQ/PQ/PPV/Mapping).
• Coordinate validation activities with cross-functional departments and vendors.
• Manage validation-related change controls and reviews to closure.
• Maintain validation schedules including process validation and temperature mapping.
• Ensure proper control and archival of validation documents and SOPs.
• Support SOPs, data integrity, backups, and information security requirements.
• Provide QA support including SAP master recipe management and IPQA activities.

Skills

Quality Assurance

Validation

cGMP

Documentation

SAP

IPQA

Training

Communication

Education

Bachelor's degree in Science/Pharma

Tools

IQ/OQ/PQ

Job description

Officer - Quality Assurance (Validation)

Ranbaxy (Malaysia) Sdn Bhd, a SUN PHARMA company, is seeking a highly motivated Officer – Quality Assurance (Validation) to join our pharmaceutical manufacturing facility in Sungai Petani, Kedah. This full-time position plays a vital role in supporting validation activities to ensure compliance with GMP requirements, regulatory standards, and internal quality systems. The successful candidate will be responsible for executing and maintaining validation programs, including equipment qualification, process validation, cleaning validation, and validation documentation. The role requires close collaboration with cross-functional teams to ensure efficient manufacturing operations, uphold quality standards, and support the timely delivery of high-quality pharmaceutical products.

Key responsibilities

• Execute qualification, validation, and cleaning validation activities in compliance with the Validation Master Plan (VMP), cGMP requirements, and company standards.
• Prepare, review, and maintain qualification and validation protocols, reports, and associated documentation (DQ, IQ, OQ, PQ, PPV, and Mapping).
• Coordinate validation and qualification activities with cross-functional departments and external vendors.
• Manage validation-related change controls and ensure timely review, approval, and closure.
• Maintain validation schedules, including process validation, cleaning validation, and temperature mapping programs.
• Ensure proper control, archival, and retrieval of validation, quality, and manufacturing documents.
• Develop, review, and update validation-related SOPs and quality documentation.
• Support computerized system compliance, including data integrity, backup and recovery, business continuity, and information security requirements.
• Conduct training on validation, SOPs, and cGMP requirements while promoting continuous audit readiness.
• Provide technical and operational QA support, including SAP master recipe management, IPQA activities, and other duties assigned by management.

About you

• Bachelor's degree in a related field such as Science related, Manufacturing, or Pharmaceutical studies
• Understanding of pharmaceutical manufacturing or production planning processes
• Strong organizational and time management skills with the ability to prioritize multiple tasks
• Excellent communication skills, both written and verbal, in English and Bahasa Malaysia
• Proficiency with Microsoft Office applications and data management systems
• Attention to detail and commitment to maintaining high-quality standards
• Ability to work collaboratively within a team environment and follow instructions
• Knowledge of lean manufacturing or continuous improvement methodologies is advantageous
• Experience in a manufacturing or production environment would be beneficial
• Competitive remuneration packages
• Comprehensive health and medical benefits
• Opportunities for professional development and advancement within a global pharmaceutical organization
• Supportive work environment that encourages learning, innovation, and collaboration

About us

Ranbaxy (Malaysia) Sdn Bhd, a SUN PHARMA company, is a leading global pharmaceutical company committed to delivering quality medicines and healthcare solutions. With a strong presence across multiple markets, we are dedicated to advancing pharmaceutical innovation and ensuring access to quality medications. Our manufacturing facility in Sungai Petani operates and plays a key role in our regional operations. We pride ourselves on our commitment to operational excellence, employee development, and contributing positively to the communities we serve. As a SUN PHARMA company, we uphold values of integrity, quality, and customer focus in everything we do.