Sr. Officer / Executive- AQA

Role & responsibilities

• Perform OOS results / OOE / laboratory events / Deviation / OOT results / Product recall / Market complaints / Stability failures etc. Investigation with identification of Root cause and appropriate corrective and preventive action are taken as per the prescribed procedures.
• Prepare OOS, OOT, OOE, Deviation and Event reports and their compliance.
• Formalize a system for quality risk identification / categorization and its mitigation.
• Monitor and ensure the compliance of quality control and GLP norms and train/retrain the personnel on the same, so plant will all time ready for regulatory inspections.
• Review investigation reports, Stability Reports, Method Verification and Method Transfer reports.
• Review relevant SOPs/Protocols/Reports/Analytical documents/Raw data/COA (Certificate of Analysis) etc. related to laboratory.
• Review the sampling / testing of starting materials / packing materials / intermediates / bulk and finished products is carried out as per approved sampling/testing plan and by validated procedures.
• Continuously improve the existing systems/procedures in line with current requirement.
• Prepare standard operation procedures.
• Perform data integrity related investigation

Desired Skills

• Should have working experience in pharmaceutical Industry preferably in Oral Solid Formulations and have regulatory exposure of USFDA/ MHRA/EU/TGA etc.
• Must have exposure of electronic system in QMS and DMS software.
• Should have basic lean / six sigma knowledge.
• Should have good verbal & written communication Skill.
• Should have analytical and problem-solving skill.
• Should be able to take initiatives and proactively seek quality solutions through emphasis on continuous improvement.