KEY RESPONSIBILITIES:
- Responsible for method development/testing and documentation of physical/chemical attributes (Assay, content uniformity, related substances, pH, solubility, water content, Rheology, Particle size, Preservatives etc) of the reference products & Kora new products.
- Development and validation of new analytical methods and methods transfer to support new product introductions.
- Responsible for the daily calibration and maintenance of laboratory equipment.
- Preparation of analytical method development protocols, Standard test Methods (STMs), product specifications, R&D reports, and Standard Operating Procedures (SOPs).
- Periodic review and update of specifications and procedures as required.
- Execution of informal stability testing campaigns to support new product development.
- Maintain up-to-date, complete, and precise records of all tests performed.
- Delivering Analytical Development Chemistry projects within agreed timeframes.
- Orders and maintains all laboratory supplies including excipients/APIs, reagents, chemicals, consumables, and instruments tools/supplies.
- Participate/support internal or external audits.
- To ensure that all work is carried out in compliance with the required company standards and conforms to cGLP, relevant SOPs, and safety and environmental guidelines.
- Other ad-hoc responsibilities as requested.
REQUIREMENRS:
- Minimum of bachelor’s degree in pharmaceutical sciences/chemistry
- Minimum 2 years of experience in analytical chemistry laboratory preferably in R&D/Manufacturing/Quality control of pharmaceutical industry
- Experience in analytical method development, method validations, optimization, continuous improvement, troubleshooting, technical transfer, operations, and risk assessments.
- Good analytical knowledge and experience of HPLC analytical technique
- Understanding of US, EU, and ICH Good Manufacturing Practices regulation concepts
- Work under Pressure & good attention to detail
