Job Description
Roles and Responsibilities
• Analysis of tablet, capsule & Pellets of semi-finished goods/Finished goods in accordance with Quality Control system and cGMP.
• Analysis of In-process samples and hold time study analysis of intermediate & final drug products.
• Analysis of raw material (API/Excipients) as per current pharmacopeia and in-house testing procedure and specification.
• Analysis of water sample as per current pharmacopeia
• Analysis of cleaning verification/ validation samples.
• To perform analytical method validation
• Analysis of packaging material (Primary, Secondary & tertiary) as per current pharmacopeia and current in-house testing procedure and specification
• Timely submission of documents pertaining to day-to-day analysis to reviewer.
• To ensure accuracy, completeness and integrity of all official documents
• Ensure safe working conditions as per guidelines issued by HSE department
• Follow standard operating procedure of quality control & analysis
• Ensure Integrity of Data at Workplace
• Assisting supervisor Quality Control for efficient functioning of Quality Control Laboratory through QC analysis and good documentation as per quality control system
• To maintain all testing records, raw data & log books as per SOP
• Follow the data integrity, cGMP, GDP, ALCOA and ALCOA+ Principle
• Maintain confidentiality and ensure safe custody and efficient handling of company document / material. Perform any other task that may be assigned for running of the company as per latest quality standard and Novartis Corporate Guidelines.
• Ensure efficient inter and intra department communications
• Any other responsibility that may be assigned by supervisor/Manager from time to time.
• Follow quality behaviors.
• Presenting and placing the analysis/decisions on work related matters before the appropriate decision making authority at appropriate time.