Executive, R&D Quality Management

Key Responsibilities
1. Analytical Testing & Laboratory Operations

Perform analytical testing on raw materials, finished products, and stability samples

Conduct comparative dissolution studies and holding time studies

Support stability studies for regulatory submission and shelf-life determination

2. Validation & Product Development Support

Support process validation and stability study testing

Assist in product scale-up activities by providing analytical insights and troubleshooting

Support pilot batch analysis and reporting

3. Method Transfer & Technical Support

Execute analytical method transfer to receiving units

Assist in troubleshooting analytical issues and ensuring method robustness

4. Documentation & Compliance

Maintain accurate raw data, technical records, and laboratory documentation

Prepare reports including validation documentation and analytical records

Ensure compliance with GLP and MS ISO/IEC 17025 laboratory practices

5. Laboratory Management & Maintenance

Maintain laboratory equipment, perform calibration, and ensure proper functioning

Manage laboratory inventory, chemicals, and consumables

Ensure a clean, safe, and compliant laboratory environment

6. Training & Knowledge Sharing

Support training of junior chemists and lab technicians on analytical methods and equipment

Share best practices in laboratory operations and troubleshooting

Requirements
Qualifications

Bachelor’s Degree in Chemistry or related field

Master’s Degree in Analytical Chemistry is an advantage

Experience

Minimum 3 years of experience in pharmaceutical laboratory or R&D environment

Experience in analytical testing, stability studies, and validation activities

Technical Skills & Expertise
Strong knowledge of analytical testing, dissolution profiling, and stability studies

Experience in analytical method validation and verification

Hands-on experience with laboratory instruments:
HPLC (UV/PDA), UPLC, GC, AAS, Dissolution, Karl Fischer, Auto-Titrator, UV-Vis, FTIR, Disintegration

Familiarity with GMP, GLP, and ISO/IEC 17025 standards

Strong documentation and report writing skills

Competencies
Strong analytical and problem-solving skills

High attention to detail and data accuracy

Ability to work independently and manage multiple tasks

Strong teamwork and communication skills

Adaptable and willing to learn in a dynamic R&D environment