Makarand Deshpande

• To Ensure appropriate execution of compliance through workflow applications like Caliber LIMS, ERP, QMS.
• Provide quality service and compliance as per cGMP requirements.
• Responsible to support in quality implementation like APQR, CPVM, change control initiator, CAPA investigation.
• Responsible to support product release as per cGMP, PNC (process non-conformance) follow-up action.
• To support product related evaluation like Analytical Method Validation, Analytical Method Transfer and Cleaning Validations.
• PNCs (process non-conformances) trending and classification.
• Developed skills in writing laboratory investigation OOS/OOT/incidents/Deviation and root cause analysis using different tools like fishbone diagram, Why-Why Analysis and brain storming. Market Complaints Review as part of QC.
• Evaluation of nitrosamines impurities and their impact on drug product and regulatory filings.
• Experience in handling of Finished Product, Raw materials, In-Process, and Hold Time Study sections reports independently and ensures the completeness of analysis within stipulated timeframe.
• Core member of Regulatory Audit compliance team and successfully complied the audit observations.
• Monthly review of Audit trials/actions/follow up.
• As part of quality compliance management responsible to implement procedures, SOPs training as per cGMP.
• Maximized performance by monitoring daily activities and mentoring team members.
• Cross-trained existing employees to maximize team agility and performance.

• Responsible to maintain high degree of Quality & compliance within laboratory area.
• Identification, Evaluation and performance of Pharmacopeial Compliance for US and Europe markets.
• Responsible to provide analytical support (Dissolution, Assay, Related substances) for the developmental projects, late-stage development as well as Life Cycle management projects received from Management.
• To Prepare the Analytical Method Equivalency protocols and Reports.
• To prepare the test methods and Method Validation Protocols and reports.
• Preparation, review, facilitate training and ensure that respective guidelines, SOPs, protocols, policies are followed.
• Responsible to review and escalate the completion of chromatographic data processing, reporting and review within time with review of System and project audit trails.
• Responsible to evaluate the test results against the trend.
• Responsible for following quality systems in all the activities meeting the cGMP requirements, Global Quality Manual and standards, local procedures and applicable regulations.
• Responsible for implementation of corrective and preventive actions as per applicable standard operating procedures to meet cGMP requirements.
• Excellent communication skills, both verbal and written.
• Skilled at working independently and collaboratively in a team environment.

Document Management

• Responsible for Preparation of Protocols and other cGMP documents and ensuring adherence to applicable regulatory requirements.
• Responsible for preparation of Method Development reports, Method Validation Protocols/Reports, Test methods, Method Transfer Protocols/Reports, Method Introduction Protocols/Reports & other technical documents.

Handling of Events & Deviations

• Responsible for coordination of Events and Deviations as per responsibilities specified in relevant standard operating procedures.
• Responsible for performing investigations and determination of root cause.

• Acted as a senior team member and led efforts to map successful filing.
• Undertaking projects and execution of analytical method development activities for Assay, Dissolution (Multimedia dissolutions, Discriminatory dissolution methods), Related Substances, PXRD, Blend assay, content of uniformity, Uniformity of dosage unit and Residual Solvents.
• Dynamically experienced in Analytical Method Development, Validation and well verse with complete forced Degradation studies and degradation pathways.
• Developed new software applications and customized existing applications to meet specific scientific project needs.
• Preparing Analytical technical documents of the in-house developed analytical methods, standard testing procedures and specifications for routine use by QC personnel as well as Managing post authorization activities: revisions, change control for approved methods, validation protocols & reports, etc.
• Maintaining basic laboratory systems and procedures related to cGMP/cGLP; informing the senior management of project status through meetings & reports.
• Co-ordinating with cross functional departments such as Product Development Department, Quality Assurance and Regulatory Affairs.

• Performed Method Development, Method Validation, Method Transfer for Related Substances, Assay and Dissolution of various dosage forms like oral solids, solutions, suspensions and Injections.
• Preparation and review of test method, specifications, method development report, method validation protocol & report.
• Troubleshooting and investigative testing for Assay, Related substances and Dissolution methods.
• Managed API-excipient compatibility studies and reverse engineering for innovator formulations.

• Performed Method Development, Method Validation, Method Transfer for Related Substances, Assay and Dissolution of various dosage forms like oral solids and PFOS.
• Preparation and review of test method, specifications, method development report, method validation protocol & report.
• Routine testing of under developed formulations.

• Performed Method Development, Method Validation, Method Transfer for Related Substances, Assay and Dissolution of various dosage forms like oral solids.
• Preparation and review of test method, specifications, method development report, method validation protocol & report.
• Adhered to laboratory safety procedures to maintain compliance with quality control standards.