Dharmendra

• Quality Strategy: Develop and implement quality strategies for Tablets, Capsules, Dry Syrups, Liquid Syrups, Dry Injections, Liquid Injections, and Ointments.
• Contract Manufacturing Oversight: Ensure compliance with GMP and quality standards at contract manufacturing sites through regular audits and inspections.
• Product Quality Assurance: Monitor and enforce quality control measures to meet product specifications and regulatory requirements.
• Regulatory Compliance: Stay updated on regulatory requirements and manage documentation for approvals and interactions with regulatory agencies.
• Risk Management: Identify quality risks, lead investigations, and implement corrective and preventive actions.
• Continuous Improvement: Drive initiatives for process optimization and enhance quality practices.
• Cross-functional Collaboration: Work with R&D, Manufacturing, and Supply Chain teams to ensure quality integration and alignment.
• Reporting: Prepare and present quality reports, metrics, and documentation for senior management.
• Customer Focus: Address customer complaints and quality issues, and monitor market feedback for improvement.
• Leadership: Lead and mentor the quality assurance team, manage resources, and promote a culture of excellence.

Managed project work for General Formulation Facility, including qualification and validation activities, system development, and execution of protocols for HVAC, Purified Water, Compressed Air, Facility, and Equipment.

• Conducted process capability and process index analysis for validated products.
• Led managerial decision-making on change control, deviations, CAPA, and addressed both internal and external constraints.
• Engaged in strategic management for internal system development.
• Monitored validation and qualification activities of facilities using a risk-based approach to ensure systems remained in a state of control.
• Executed cleaning validation, including matrix preparation and selection of worst-case products.
• Managed facility qualification, encompassing Compressed Air, HVAC, Water Systems, Equipment, and Instruments.
• Planned and executed vendor audits, ensuring compliance based on ranking and filtering criteria.

• Led the preparation and review of key documents such as the Site Master File, Quality Manual, and Validation Master Plan, ensuring compliance with change control impact assessments.
• Reviewed and approved Process Validation Protocols, Reports, and risk assessments; trained the process validation team on OSD formulations.
• Managed investigations into deviations, OOS, and OOT incidents using Six Sigma tools for root cause analysis.
• Oversaw the review and approval of change control documents and related activities.
• Conducted analytical report reviews and AQA activities, including OOS/OOT investigations.
• Coordinated with product development labs to resolve product and process issues.
• Approved qualification documents for equipment and utilities, and trained teams on protocol execution.
• Enhanced the Quality System, focusing on compliance with cGxP/GAMP standards and continuous improvement.
• Planned and executed vendor audits based on risk assessments and compliance.
• Reviewed SOPs and cGMP documents, ensuring data integrity and regulatory adherence.
• Evaluated cleaning matrices for new products and trained teams on revised cleaning validation protocols.
• Managed validation and qualification for new facility projects using risk-based approaches.
• Monitored CAPA trends and managed the QMS to ensure quality assurance.

• Led the preparation and review of key documents such as the Site Master File, Quality Manual, and Validation Master Plan, ensuring compliance with change control impact assessments.
• Reviewed and approved Process Validation Protocols, Reports, and risk assessments; trained the process validation team on OSD formulations.
• Managed investigations into deviations, OOS, and OOT incidents using Six Sigma tools for root cause analysis.
• Oversaw the review and approval of change control documents and related activities.
• Conducted analytical report reviews and AQA activities, including OOS/OOT investigations.
• Coordinated with product development labs to resolve product and process issues.
• Approved qualification documents for equipment and utilities, and trained teams on protocol execution.
• Enhanced the Quality System, focusing on compliance with cGxP/GAMP standards and continuous improvement.
• Planned and executed vendor audits based on risk assessments and compliance.
• Reviewed SOPs and cGMP documents, ensuring data integrity and regulatory adherence.
• Evaluated cleaning matrices for new products and trained teams on revised cleaning validation protocols.
• Managed validation and qualification for new facility projects using risk-based approaches.
• Monitored CAPA trends and managed the QMS to ensure quality assurance.

• Led the preparation and review of key documents such as the Site Master File, Quality Manual, and Validation Master Plan, ensuring compliance with change control impact assessments.
• Reviewed and approved Process Validation Protocols, Reports, and risk assessments; trained the process validation team on OSD formulations.
• Managed investigations into deviations, OOS, and OOT incidents using Six Sigma tools for root cause analysis.
• Oversaw the review and approval of change control documents and related activities.
• Conducted analytical report reviews and AQA activities, including OOS/OOT investigations.
• Coordinated with product development labs to resolve product and process issues.
• Approved qualification documents for equipment and utilities, and trained teams on protocol execution.
• Enhanced the Quality System, focusing on compliance with cGxP/GAMP standards and continuous improvement.
• Planned and executed vendor audits based on risk assessments and compliance.
• Reviewed SOPs and cGMP documents, ensuring data integrity and regulatory adherence.
• Evaluated cleaning matrices for new products and trained teams on revised cleaning validation protocols.
• Managed validation and qualification for new facility projects using risk-based approaches.
• Monitored CAPA trends and managed the QMS to ensure quality assurance.