Assistant Manager/Senior Executive, R&D Quality Management

Duopharma Biotech; Selangor; On-site; MYR 120,000 - 180,000; Full time

Job summary

Duopharma Innovation Sdn Bhd is seeking an experienced Assistant Manager/Senior Executive for R&D Quality Management to lead analytical laboratory activities and ensure compliance with GMP, GLP, ISO standards, and regulatory requirements.

The role involves overseeing analysts, supporting pilot batches, process validation, method transfer, documentation review, and contributing to quality systems for pharmaceutical product development and regulatory submissions.

Qualifications

• Bachelor's degree in relevant scientific discipline.
• 5+ years for Senior Executive; 10+ years for Assistant Manager.
• Experience in regulated pharmaceutical labs, R&D QC, and analytical testing.

Responsibilities

• Coordinate daily analytical laboratory activities, projects and personnel.
• Support regulatory submissions and quality management activities.
• Ensure GMP, GLP, ISO 9001, ISO 13485, ISO/IEC 17025 compliance.
• Oversee method transfer, technology transfer, and documentation review.

Skills

Analytical testing

Quality management

Laboratory leadership

Regulatory knowledge

Project management

Education

Bachelor's degree in Biotechnology, Pharmaceutical Science, Chemistry, Analytical Science, or related

Tools

Analytical instruments

Job description

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Assistant Manager/Senior Executive, R&D Quality Management

Assistant Manager/Senior Executive, R&D Quality Management

Location: Glenmarie, Selangor
Company: Duopharma Innovation Sdn Bhd

Job Summary

We are seeking an experienced and technically competent Assistant Manager to support our R&D Quality Management team. This role is responsible for managing analytical laboratory activities, supporting pilot batches and process validation projects, overseeing analysts, and ensuring laboratory operations comply with applicable GMP, GLP, ISO 9001, ISO 13485, and ISO/IEC 17025 requirements.

The successful candidate will play a key role in analytical testing, method transfer, technology transfer, stability studies, qualification activities, and the review of quality and technical documentation supporting pharmaceutical product development and regulatory submissions.

Key Responsibilities

Laboratory & R&D Quality Management

• Manage and coordinate daily analytical laboratory activities, projects, and personnel.
• Support R&D Quality Management activities and analytical requirements for regulatory submissions.
• Ensure laboratory operations comply with GMP Annex 13, Good Laboratory Practice (GLP), ISO 9001, ISO 13485, and applicable ISO/IEC 17025 practices.
• Assist in planning, organising, controlling, and directing R&D and laboratory activities.

Analytical Testing & Validation

• Manage and support analytical testing for pilot batches, process validation, stability studies, and product development projects.
• Support IQ, OQ, and other equipment qualification activities, including temperature mapping.
• Ensure all testing activities are conducted in accordance with approved Protocols of Analysis (POA) and relevant procedures.
• Initiate troubleshooting and problem-solving activities to address technical issues and improve laboratory performance.

Analytical Method & Technology Transfer

• Support Analytical Method Transfer (AMT) and technology transfer activities during product scale-up and commercialisation.
• Coordinate method transfer to receiving or commercial technical teams.
• Provide technical analytical information, troubleshoot issues, and advise on appropriate precautions during analytical activities.
• Support cross-functional teams in ensuring successful product and method transfer.

Documentation & Quality Compliance

• Prepare, review, and approve Quality Management and technical documentation.
• Review documentation related to pilot batches, process validation, analytical method transfer, and technology transfer activities.
• Review protocols and reports, including stability studies, Comparative Dissolution Profile (CDP), temperature mapping, pilot batches, and process validation.
• Review and approve documents such as IQ, OQ, PQ, URS, Certificates of Analysis (CoA), and Stability Summary Reports (SSR).
• Ensure documentation complies with applicable GMP, ICH, ASEAN, and other relevant regulatory guidelines.

Laboratory Management

• Support the management and maintenance of laboratory equipment.
• Manage laboratory inventory, chemicals, consumables, and operating supplies.
• Ensure laboratory cleanliness, organisation, and readiness for daily operations.
• Support continuous improvement initiatives to enhance laboratory efficiency, quality, and compliance.

Requirements

Qualifications

• Bachelor's Degree in Biotechnology, Pharmaceutical Science, Chemistry, Analytical Science, or a related scientific discipline.
• Minimum 5 years of working experience for Senior Executive & 10 years of working experience for Assistant Manager

Experience

• Significant working experience in the pharmaceutical or related regulated industry.
• Experience in analytical laboratory operations, pharmaceutical R&D, Quality Management, or analytical testing is preferred.
• Experience managing laboratory personnel and projects will be an added advantage.

Technical Skills & Knowledge

• Good knowledge of pharmaceutical regulatory requirements and guidelines, including NPRA, FDA, ICH, ASEAN, EMEA, GLP, and WHO requirements.
• Knowledge of formulation support studies, pilot batch studies, process validation, and analytical method validation.
• Strong project management and technical problem-solving skills.
• Experience reviewing and preparing technical protocols and reports.
• Hands-on experience with analytical instruments will be an added advantage.

Key Competencies

• Strong analytical and research capabilities.
• Excellent troubleshooting and problem-solving skills.
• Strong leadership and team management abilities.
• Good project planning and organisational skills.
• Ability to communicate effectively with employees at all levels.
• Strong attention to detail and commitment to quality and compliance.
• Ability to motivate and lead a team in a highly regulated environment.