Bhagwati Prasad Semwal

(Overview of Naari Pharma: A group company of Strides Shashun Ltd having various regulatory approvals; USFDA, EUGMP, TGA, Health Canada and other semi-regulatory authorities)

• Overall responsible for the Quality control activities at site for hormonal solid oral dosage forms.
• Ensure all time readiness for compliance in the QC laboratory.
• Administering continuous improvement in the quality system to improve the overall compliance in line with the GMP/GLP and Regulatory standards.
• Controlling the workforce and schedule to ensure the provision of adequate resources in the quality control function within budget.
• Supporting the regulatory filings, submission and annual product review for annual regulatory commitments and timelines.
• Driving the timely release of IP, FP, RM and PM as per service level agreement.
• Managing the stability studies of commercial and exhibit batches and releasing the stability samples within window.
• Ensuring timely initiation and appropriate closure of OOS, OOT, CAPA, Change controls and deviations.
• Conducting Root cause analysis and reviewing OOS/OOT reports.
• Providing CAPA for regulatory audits and internal audits
• Conducting internal audits and supporting external audits.
• Organizing periodic review with all stakeholders.
• Review and approval of SOP's, Equipment/Instrument qualification protocol and reports.
• Monitoring the calibration (Internal/external) and supervising preventive maintenance as per schedule.
• Review and approval of analytical method transfer and validation protocols.
• Establishing comprehensive employee training programs to develop skills, improve productivity, and maintain compliance with industry regulations.

• Preparation of analytical method validation protocol for finished dosage forms including Tablets, Capsules, Injectables, Ophthalmic solution, Oral suspension etc.
• Supervise subordinate team members in planning and execution of analytical method validation.
• Review method validation data of subordinate team members.
• Preparation of method validation report.
• Provide technical input in troubleshooting during method validation activity.
• Response to deficiency queries received from regulatory agencies.
• Method transfer Assignments from R&D to Plant and outsourced organization.
• Calibrations of HPLC instruments and Dissolution Apparatus.
• Planning and execution of method equivalency between in-house and pharmacopeia method.
• Preparation and review analytical method transfer protocol and reports.
• Deftly solving the problem during method transfer and execution of method transfer activity.
• Facing the internal audits and ensuring GLP compliance in Lab.
• Method development and Validation for Particle size distribution using Malvern mastersizer

• Project planning, execution, method development and validation of projects according to set standards as USP general chapters, guidelines, SOPs and protocols.
• Development of analytical methods of various dosage forms (tablets, capsules, suspension, injectable and ophthalmic) using HPLC/UV-VIS Spectrophotometer techniques to support the formulations development.
• Validation of analytical methods of various dosage forms (tablets, capsules, suspension, injectable and ophthalmic) using HPLC techniques.
• Preparation of Validation protocol and validation report.
• Method transfer activities for solid dosage formulations from R&D to Plant (Total 25 methods transferred successfully)
• Review method transfer protocol and its report.
• Deft at facing internal audit & QA audit.
• Standardization of working standard.
• Spearheading the task such Validation and Routine Analysis (assay, related substances and dissolution) & training the new comers efficiently.
• Efficient at resolving the query received from any regulatory agency.
• Analysis of In house Prototype formulations and Innovator Products of IR and NDDS Formulations for EU and US market.

• Development of analytical methods of API using HPLC/UV-VIS Spectrophotometer techniques.
• Validation of analytical methods of API using HPLC/UV-VIS Spectrophotometer techniques.
• Perform the Assay and Related substances of API and Dosage form (tablets & capsules) by HPLC.