Sr. Auditor- QA

Allotting retrospective data to team and maintaining project timelines. Forecasting of Meetings and Audits. Filing of Regulatory approval applications. Drafting and Reviewing of Response for Regulatory/Sponsor queries. Regular meetings with Management and Operations Stakeholders for continuous improvement. Participate in project schedule meetings and plan for QA deliverables for a project to meet the timelines. Execute audits of vendors, both onsite and offsite, and compile the qualification report for release. Assist in the preparation of the unit for regulatory inspection and client/sponsor audits. Conduct of Annual/Biannual training sessions like Data Integrity 21 CFR Part 11, GDP, GMP, GLP & GCP, and Monthly sessions on SOP’s, Refreshments trainings, but not limited to. Leading System Audits. Preparation, Review and Presentation of Trend Analysis. Review of required controlled copies of SOP’s, SOP Amendments, Forms, Logbooks, and Project related Protocols and documents and ensure that the procedures are in line with current regulatory requirements. Review of Retrospective data like Method Development/Method Validation/Study data on LC-MS/MS and Preparation of Audit Reports/QA statements for the respective raw data. Review of EDMS (Electronic Data Management System). Review of eCTD (electronic Common Technical Document). Review of Document Distribution, Archival, Retrieval and Destruction accountability records. Review of WinNonlin and Statistical data by comparing them with the source data like Protocol, Statistical data, Randomization, Covering letter, etc., but not limited to. Review of Master List of SOP’s. Review of Eurotherm Prints. Review of Quality Manual, Site Master File, Organogram, Staff list and Annexures. Periodic verification of facility-related registers and layouts. Periodic verification of logbooks in the Bioanalytical department. Conduct in-process and retrospective audits of raw data generated during the project in compliance with the Protocol and SOP’s. Review of deviations and CAPA plans. Follow-up CAPA plans to ensure audit findings are resolved promptly and its implementation. Review of IQ, OQ, PQ, and Calibration documents. Prepare Quality report and report to line manager. Perform other related duties as assigned by the HOD/Line Manager/designee.

Carry out periodic Inspections and Internal Quality Audits. Review of Retrospective Method Development/Method Validation/Study data and Preparation of Audit Reports/QA statements for the respective raw data analysed on LC-MS/MS and ICP-MS. Review of WinNonlin and Statistical data by comparing them with the source data like Protocol, Statistical data, Randomization, Covering letter, etc., but not limited to. Review of SOP’s, STP’s, and Protocols as per in-house applicable procedures and ensure that they are in line with current regulatory requirements. Ensuring the compliance of Bioanalytical Method Development, Method Validations and Studies/Projects carried out in compliance with the applicable procedures (Protocols, SOP’s, and any other applicable procedures). Preparation and Review of SOP’s and Manuals of Quality procedures. Review of Eurotherm Prints. Preparation and Review of Quality Manual, Site Master File, Organogram and Annexures. Compliance Verification of the Calibrations and Preventive Maintenance of the Instruments/Equipment’s. Compliance Verification of Quality-related documents like Change Controls and Deviations, if any. Issuance of Protocols, SOP’s, Formats, CRF’s, and other applicable controlled and uncontrolled copies to the respective departments and outside of Actimus Biosciences respectively. Control, Revise, Archive, Retrieve, Obsolete and Destruct of documents like Protocols, SOP’s, Formats, ICF’s, CRF’s, and other applicable Procedures. Review of study-related documents like chromatograms, dispatch documents but not limited to. Verification of Logbooks, records, system-related documents, and study reports. Archiving the study reports and documents generated at Actimus Biosciences. Any other task delegated by the Head of the Department/Designee. Control, Revise, Archive, Retrieve, Obsolete and Destruct of documents like Protocols, SOPs, Formats, ICF’s, CRF’s, and other applicable Procedures. Conduct in-process like Screening, Check-in, AV recording, Dispensing, Dosing, Sample Collection, Vitals, Check-out, Ambulatory Sample collection, but not limited to. Review of Deviations, Change Controls, Calibration Records. Review of all QMS related activities. Review of OOS (Out of Specification), CAPA (Corrective Action Preventive Action), LIR (Lab Investigation Report), Investigation, Deviations, Change Controls, Calibrations. Conducting Internal audits. Review of IQ/OQ/PQ of Instruments. Review of facility layout as per the blueprint.

Maintain tracking to allow for proper corrections of internal and external audit major/minor non-conformances and improvement observations following Hospital Standards. Review process and documentation to ensure quality frameworks, forms, references, and links are established. Controlling and maintaining physical documents, ledgers, stock excels, and bills. Provide internal training for QMS functions including organizational training and subject matter expertise for QMS compliance and process improvements. Receives and interprets physicians' medication orders. Contributes to the quality and effective operation of the Pharmacy Department. Correctly inform and instruct patients on any drugs to be used after they are discharged. Provide leadership and guidance to ensure leading-edge business practices are defined and implemented. Highly motivated, quick thinking, and able to convey ideas and present unconventional solutions to unique problems. Provides drug information to other healthcare professionals and patients. Provide clinical support for hospital pharmacy functions in a fast-paced environment. Assumes responsibility for delivering pharmaceutical care to patient groups served by the pharmacy in which the pharmacist is scheduled to work. Develops and participates in new employee training and education programs. Oriented, mentored, and trained new pharmacists, improving performance to the maximum extent possible. Participates in patient drug therapy monitoring.

Responsible for accurately dispensing prescription medications to patients and ensuring that the right drug, dose, and instructions are provided. Maintaining ledgers and stocks. Played a key role in ensuring medication quality and safety by verifying pharmaceutical products' integrity. As a process of medication management, reviewed medication orders, assessed drug interactions, and checked for allergies to ensure safe and appropriate medication use. Counselled patients on how to take medications on time, potential side effects, and any precautions they need to be aware of. Provided accurate and up-to-date drug information to healthcare professionals, patients, and caregivers. Responsible for managing drug inventory, ordering medications, and maintaining appropriate stock levels. Oriented, mentored, and trained new pharmacists, improving performance to the maximum extent possible. Involved in health promotion activities such as vaccination programs and smoking cessation counselling. Engage in research and educational activities to advance pharmacy practice and contribute to the scientific community.

Specialized in teaching Anatomy, Physiology, Biology, and Natural Sciences. Proficient in providing comprehensive and engaging tutoring sessions to students of diverse backgrounds. Skilled in explaining complex concepts clearly and understandably, fostering effective learning. Demonstrated ability to adapt teaching methods to accommodate individual learning styles and pace. Committed to supporting students' academic growth and success by offering guidance and constructive feedback.