Assistant Manager - QMS

Role & responsibilities

• Develop strategy, drive quality culture, quality improvement initiatives to compliance and output in line with new technologies and regulatory benchmark and expectations.
• Perform, identify and evaluate risks identified during review meetings; launch of products, facilities, processes; review change and approve the same with proper assessment.
• Ensure all-time audit readiness and participate in the regulatory inspections and related response discussions, monitor progress on closure of observations.
• Handle deviations, change controls, market complaints, adverse drug reactions / events, CAPA, OOS, OOT, & risk assessment.
• Coordinate and conduct the required investigation for any reported OOS results / Deviation / OOT results / Product recall / Market complaints/ Stability failures etc. and prepare detailed investigation report.
• Perform periodic review of change controls / deviation and CAPA.
• Track implementation of suggested corrective and preventive actions against reported OOS results / Deviation / OOT results / Product recall / Market complaints / Stability failures / Audit outcomes or initiated for any improvements etc.
• Perform quality risk management (QRM).
• Prepare and evaluate trending of deviation control, change control and market complaints.
• Prepare and review the standard operating procedures & study protocols relevant to QMS.
• Perform Nitrosamine, risk assessment and elemental impurity risk assessment for the drug products.
• Prepare quality metrics, special Implementation team & management review meeting report.
• Organize and coordinate the scheduled / unscheduled self-inspection

KEY SKILLS and COMPETENCIES

• 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 excellent 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.