Manager - Production & QMS

• Expertise in the manufacturing dosage forms & related process
• Knowledge about new technology & equipment used in production
• Exposure to regulatory audits like USFDA/MHRA/ANVISA, customer audits
• Knowledge of handling manufacturing and packaging machinery
• Manpower Management
• Maintain the area with zero non-compliance & zero critical incidents
• Monitoring the systems as per the instructions of the SOPs
• To review and comply the observation of internal and regulatory audits
• To coordinate with supporting departments for production and compliance related activity
• Good Interpersonal Skills
• Team Building Skills
• Strategic and Critical Thinking & Forecasting
• Ability to work in a diverse team
• Prepare and review of manufacturing investigations for OOS, OOT, market complaints and provide CAPA and to implement and ensure its effectiveness
• To perform gap analysis with respect to cGMP guidelines, current regulatory requirements & corporate policies/ SOPs, wherever required and to comply with the requirements and endorse the same.
• Ensures proper training is being done to all the personnel regarding the process, SOPs, Compliance with CAPA.
• Ensure the technical writing in line with regulatory guideline.
• Ensure the effectiveness of the CAPA

Updating cGMP related practices and recent regulatory upgradation to the personnel working in the shop floor to improve the systems