Qa Manager

9 hours ago

Barwala HR IN HABITARE PHARMA Full time

Habitare Pharmaceuticals Private Limited is a premier third-party pharmaceutical product manufacturing company specializing in Non-Beta Tablets Capsules Oral Liquids External Applications Ointments Gels Medicated Creams Lotions and more Roles and Responsibility Ensure compliance with cGMP GLP GDP WHO ICH and regulatory guidelines Establish implement and monitor Quality Management Systems QMS Oversee batch release documentation control and product quality reviews 2 Documentation SOP Management Create review and approve SOPs validation protocols batch manufacturing records and related documents Ensure proper document control revision management and archival practices 3 Compliance Regulatory Support Prepare for and actively participate in regulatory audits FDA WHO GMP ISO State FDA etc Coordinate internal and external audits ensure timely closure of observations CAPA management Review regulatory submissions related to QA 4 QMS Quality Management System Management Responsible for change control deviation management OOS OOT investigations and preventive actions Ensure timely investigation and root cause analysis Maintain risk assessment and mitigation processes 5 Batch Release Review Review batch manufacturing and packing records for accuracy and completeness Approve batches for release ensuring compliance with specifications Oversee raw material in-process and finished product quality assurance activities 6 Training Team Management Train plant personnel on GMP SOPs quality standards and best practices Lead and mentor QA team members Promote a strong culture of quality across departments 7 Validation Qualification Oversee equipment qualification DQ IQ OQ PQ and validation of utilities processes cleaning and analytical methods Approve validation protocols and reports 8 Vendor Material Quality Assurance Approve and audit suppliers of raw materials packaging materials and service providers Review vendor qualification and re-evaluation reports Ensure material quality compliance 9 Investigation CAPA Management Lead investigations for deviations non-conformities and customer complaints Implement effective CAPAs and track closure Conduct periodic quality reviews and trend analysis 10 Quality Risk Management Implement risk assessment tools FMEA HACCP Fishbone etc Ensure continuous improvement in plant quality operations 11 Product Quality Compliance Monitoring Oversee stability study programs Monitor environmental conditions for manufacturing temperature RH clean room classification Ensure adherence to quality metrics and KPIs 12 Coordination With Other Departments Work closely with Production QC Engineering R D Warehouse and management teams Ensure smooth communication and resolution of quality-related issues 13 Customer Complaint Handling Investigate market complaints Implement corrective actions and preventive systems to avoid recurrence 14 Continual Improvement Drive root cause analysis quality improvement projects and process optimization Evaluate and implement industry best practices Job Type Full-time Pay 12 000 00 - 40 000 00 per month Education Bachelor s Preferred Experience Tally 1 year Required Work Location In person

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