SAI VIVEK KOSARAJU

1. Preparation Reviewing and approving of quality policy and objectives.

2. Preparation, Review and approval of QMS Documents

3. Conducting review meetings and keeping track on the MRM decisions.

4. Selection and approval of suppliers based on evaluation reports submitted by the Manager - Warehouse

5. Review and approval of purchase orders about raw materials and other critical items based on requirement

6. Preparation and review of the QMS documents

7. Review the requirements of the customers periodically.

8. Coordinating with the team in solving customer complaints and initiating corrective and preventive actions.

9. Will Act as Management representative and Responsible for overall quality aspects of the organization including

a. Quality Management Systems:Develop and maintain comprehensive quality management systems, including policies, procedures, and standards, to ensure consistent quality across all company operations.

b. Regulatory Compliance: Ensure that the company complies with all relevant industry regulations, standards, and certifications related to irradiation processes, safety, and product quality.

c. Quality Audits: Conduct and manage internal and external quality audits to identify areas for improvement and ensure adherence to quality standards.

d. Quality Control: Oversee quality control processes, including inspection, testing, and quality checks on irradiated products to verify their conformity to specifications.

e. Process Improvement: Drive continuous improvement initiatives by identifying areas of inefficiency, non-conformance, and implementing corrective and preventive actions.

f. Documentation: Maintain accurate and up-to-date quality documentation, including records, reports, and certifications.

g. Supplier Quality Management: Collaborate with suppliers to ensure the quality of raw materials and components used in the irradiation process.

h. Training and Development: Provide training and guidance to staff to enhance their understanding of quality standards and practices.

i. Customer Feedback: Collect and analyse customer feedback to identify areas for improvement and address any quality-related issues.

j. Risk Management: Identify and assess quality-related risks and implement strategies to mitigate them.

k. Quality Management: You will be responsible for overseeing and maintaining the Quality Management System (QMS) of the company. This includes implementing and adhering to ISO standards, ensuring compliance with regulatory requirements, and continuously improving our processes.

l. Process Improvement: Collaborate with various departments to identify areas for process improvement, develop strategies for enhancement, and monitor the progress of improvement initiatives.

• Monitored staff organization and suggested improvements to daily functionality.
• Implemented new quality assurance and customer service standards.
• Created and maintained quality management systems to align with industry standards.
• Certified Internal Auditor for ISO 9001 and 13485 quality systems.
• Under my tenure certified the company as per ISO 9001 and 13485 standards with DNV certifying Agency
• Improved overall efficiency of the QA department through strategic planning and resource allocation

• Quality Risk Management: Initiation of Quality Risk Assessment studies through Failure Mode Effects Analysis tool. Identification of QRM team and preparation of process mapping Co ordination with the team for timely implementation of risk mitigation actions and periodic reviews to ensure the effectiveness.
• Market Complaints: Logging of complaints at unit level and evaluation of complaint samples with the cross functional teams. Escalation of issues to the drug safety department. Supporting to
  the cross functional teams for preparation and review of Market complaints investigation reports.
• Self-Inspection: As a certified self-inspection auditor involvement in internal audits at plant level and supports senior auditors for review and identification of non-conformances Involvement in Pre and Post audit discussions.
• Responsible for conducting & completion of ( SOP'S, PROTOCOLS, BMR'S, GMP & GDP)Trainings to Operators and Executives within speculated time.
• Review of Draft BMR'S for execution of Exhibit and commercial batches.
• Logging and initial review of incidents/deviations reported from the Cross functional departments including Quality Assurance.
• Conduct Brain Storm sessions with the stake holders to identify the right Investigational tools and Impact Analysis with appropriate Investigation plan.
• Preparation of Deviations data for Score Card/ Quality Metrics and Quality Review Meetings.
• Periodic review of cross functional department documents to identify the gaps.
• Involvement in meetings with vendors for non-conformities noticed in Raw materials and Primary Packing Materials.
• Developed strong communication and organizational skills through working on group projects.
• Paid attention to detail while completing assignments.
• Supporting to the team for audit preparation and during audits for on time submission of documents/evidences.

Handling of Incident/Deviation:

• Logging and initial review of incidents/deviations reported from the cross-functional departments including Quality Assurance.
• Classification of the reported events based on the risk associated as per the Risk Priority Number.
• Conduct Brain Storm sessions with the stake holders to identify the right Investigational tools and Impact Analysis with appropriate Investigation plan.
• Thorough review of investigation reports to ensure the adequate correction, corrective action and Preventive actions to the reported non-conformities.
• Verification of proposed corrective and preventive actions prior to implementation.
• Identification of recurring events in stipulated period and initiation of comprehensive investigations to address the cause for the recurrence. Preparation of deviation trends (Monthly/ Quarterly/ Rolling) and contribution for organizational trends preparation.
• Preparation of Deviations data for Score Card/ Quality Metrics and Quality Review Meetings.
• Handling of CAPA’s:
• Verification of sources of Corrective actions and Preventive actions such as failure investigations, customer complaints, APQR, internal or external audits and causes including misinterpretation of instructions or poor training.
• Logging of CAPAs and identification of respective personnel for implementation of identified corrective and preventive actions with adequate timelines proposed.
• Periodic follow-ups to the CAPA stake holders to update the implementation status of the proposed CAPAs to the management with justifications for any delay in actions implementation.
• Effectiveness verification of Proposed and implemented CAPAs with particular Actions, Time frame and Metrics.
• Preparation CAPA Trends on periodic basis to update Quality Metrics/ Score card/ Quality Review Meetings.
• Handling of Change Controls:
• Updating of change control logs upon receipt and initial review of changes proposed with respect to existing system.
• Verification of proposed changes and validation of rationale/reason for the changes proposed. Identification of functional areas to assess the impact of the changes proposed.
• Preparation of overall impact assessment based on the functional assessment by the cross functional departments.
• Identification of action owners and preparation of implementation metrics with stipulated timelines.
• Updation of actions implementation status on periodic basis with justification for delay in implementation.
• Collection, review and archival of attachments/documents related to implemented changes prior to change control closure.
• Preparation of change control trends on periodic basis to update Quality Metrics/ Score Card/ Quality Review Meetings.

• IPQA responsibilities (Line Clearance and Line monitoring) in Aseptic manufacturing, visual Inspection and Packing area.
• Review of BMR for compliance
• Monitored daily activities in the floor during the production as a part of Quality assurance.
• Preparation and execution of miscellaneous protocols.
• Responsible for Sample collections at different stages.
• Execution of submission and process validation batches.
• Qualified visual inspector for Small volume parenteral and involved in performing the Acceptable Quality limit tests (AQL).
• Periodic review of cross functional department documents to identify the gaps.
• Verification of sources of Corrective actions and Preventive actions such as failure investigations, customer complaints, APQR, internal or external audits and causes including misinterpretation of instructions or poor training.
• Logging of CAPAs and identification of respective personnel for implementation of identified corrective and preventive actions with adequate timelines proposed.

• Responsible for conducting & completion of ( SOP’S, PROTOCOLS, BMR’S, GMP & GDP) Trainings to Operators and Executives within speculated time.
• Review of Draft BMR’S for execution of Exhibit and commercial batches.
• Responsible for the giving the line clearance for the manufacturing of the drug product.
• Responsible for compounding of drug product as per the written instruction mentioned in the BMR and cGMP requirements.
• Responsible for In- process checks for each and every step during compounding and filling as per the instruction mentioned in the BMR and confirmed to the specification and sampling according to protocol.
• Collection of In process samples, Reserve sample, Bulk samples, finished samples and stability samples for analysis as per protocols/BMR’s/BPR’s.
• Responsible for collection of Swabs and surface swabs from equipment’s according to cleaning validation protocol.
• Monitoring of the environmental parameters such as Temperature, Humidity, LAF Pressures and Differential pressures.
• Monitoring of the Non – viable particle count data and responsible for performing the action as per the SOP when the counts exceed the action alarm limit.
• Ensuring the online documentation in practice by ensuring regular updating of Log books, Status labels, manufacturing records.
• Initiation of noncompliance reporting, intimation to the department supervisor/in charge and ensure the corrective action, if any deviations observed.
• Assistance in validation programs from time to time of instruments. Ensure the CIP & SIP of vessels and all autoclave loads before start of the batch manufacturing.
• Responsible for the execution of process validation, Review of BMR & BPR.

• IPQA responsibilities (Line Clearance and Line monitoring) in Terminal sterilization, visual Inspection and Packing area.
• Monitored daily activities in the floor during the production as a part of Quality assurance.
• Responsible for the investigation of Events and incidents which are related to manufacturing related observations
• Performing the initial impact assessment related to the Deviations.
• Qualified visual inspector for Small volume parenterals and involved in performing the Acceptable Quality limit tests (AQL).
• Involved in Batch release activities.
• As an Administrator for the equipment’s in in the area of Visual inspection and Packaging areas involved in the product qualification activities and recipe creation activity.
• Having the sound knowledge in the SAP and performed the activities in the floor through SAP as a platform.
• Handling of quality notifications in SAP, a Quality tool for assessing the non-compliances which comes in regular manufacturing activities.
• Involved in the Online Review of Batch reports through SAP.
• Review of Electronic change controls MPR and BPR related to compounding ,filling, packing ,visual inspection and Terminal sterilization area.
• Preparation and Review of SOP’s related to the compounding, filling, packing, visual inspection and Terminal sterilization area.
• Preparation and execution of miscellaneous protocols.
• Responsible for Sample collections at different stages.
• Execution of submission and process validation batches.
• Review of documents related to the respective area