Job Responsibilities

• Develop and validate analytical methods in support of R&D product development.
• Develop and validate analytical cleaning methods in support of Cleaning Validation / Verification.
• Provide analytical technical support of R&D product development.
• Provide IPQA support for Production Operations.
• Perform relevant physical characterization of pharmaceutical products by development of discriminating dissolution methods.
• Perform RLD evaluation, including reverse engineering principles.
• Perform API characterization and raw material testing, including chemical and physical tests utilizing both Vendor methods and USP/NF monographs.
• Troubleshoot, calibrate and maintain analytical instrumentation.
• Write experimental protocols, summary reports, analytical methods, SOPs.
• Maintain appropriate documentation (records and lab notebook) for all processes, observations and results as per SOPs and test methods.
• Learn new techniques and solve complex analytical problems.
• Perform training for team members.
• OOS investigations and develop appropriate action plans to deliver innovative solutions and definitive root cause analysis.
• Compile and submit ANDA, PAS, CBE 30 and other supplement.
• Interact effectively with multi cross-functional teams and work closely with other departments for preparation of regulatory filings.
• Comply with lab SOPs, GLP, GMP, and company safety requirements.
• Perform investigation deviation, market complaint and Incident.
• Perform self-inspection and external vendors audit.
• Perform other related duties as assigned to meet departmental and company objectives.