Preeta Caroline

General Responsibilities:

• Perform and facilitate document management process to ensure timely revision, review, approval, and effectiveness of controlled GXP documents.
• Documents in scope include both electronic and paper versions using Experience and knowledge of global Quality Management Systems (QMS), Experience with IT systems used in industry, including TrackWise, Learning Management (SumTotal preferred) and Microsoft Office Applications.

Key responsibilities encompass:

• Timely completion of mandatory training on procedures and systems, with sustained adherence to training and certification requirements specified in job profile or curriculum.
• Scrutinizing and enhancing document metadata to ensure its compatibility with electronic systems.
• Collaborating closely with document owners to maintain alignment and currency of content, format, and links.
• Fostering collaboration with training department to synchronize content and timeline inputs.
• Providing valuable support during inspections and audits by conducting systematic queries of both systems and documents.
• Contributing to initiatives aimed at archiving retired and decommissioned documents and records.
• Assisting in execution of routine periodic review requirements.
• Checked accuracy and completeness of documents to identify deficiencies and recommend corrective actions

Work achievements:

• Obtained certification for Technical Writing Principles from Pathwise on 30-Aug-2023.
• Assisted during migration of document management system from Alexion Vault Quality systems to AstraZeneca ECMS to ensure compliance.
• Certified lead investigator for deviations managed within ECMS
• Trained new joinees about system and procedures.

Job Responsibilities:

• Planning resources and conducting audits (site audits, vendor audits, in house audits, system audits etc.) to identify deviations from applicable guidelines, regulations and Protocol (wherever applicable).
• Sensitizing individuals and teams on deviations and process followed thereof to influence corrective actions to be carried out.
• Collating and analyzing audit reports to identify systemic root causes of defects and partner with relevant stakeholders (including head of monitoring, project management, project manager, HR and training) for enabling process improvements leading to deviations minimization/amelioration.
• Developing and executing QA SOPs, in line with global best practices, related to QA activities, such that resources including time and costs are optimized.
• Coordinating and developing SOPs, in line with global best practices, related to activities in study monitoring, project management etc.
• Ensuring effective training to all colleagues, differentially as per QA norms/SOPs to ensure deep understanding, internalization and adherence of SOPs by colleagues.
• Reviewing documents (e.g. protocol, informed consent document, case report forms etc.) created in-house or received from sponsor for their compliance to applicable guidelines, regulations and protocol wherever applicable and provide feedback.
• Reviewing study files for QA green signal for first-time release of study drugs to site or site initiation.
• Carrying out special audits driven by the director based on business exigencies. Coordinating external audits and inspections.

Work Achievements:

• Participated in 7 COVID-19 trials since April 2020 including COVID-19 vaccine trial as Quality Assurance Personnel.
• Participated in several personal care studies as Quality Assurance personnel.
• Participated in Clinical Research course conducted by the organization as a trainer and coordinator.
• Help build the quality management system and was an active part of the getting the organization ISO 9001 certification.

Job Responsibilities:

• Responsible for QMS (Quality Management System) of departments related to Bioanalytical Research Laboratory – viz. GLP and relevant BA / BE guidelines; Data Management and Biostatistics and other support departments as per requirement. reparation and revision of SOPs’ relevant to their area; review of SOPs’ from relevant departments; issue of SOPs’, forms and log books to relevant departments; retrieval of obsolete SOPs’; control of master (original) SOPs’ – current as well as obsolete SOPs’. Any other responsibilities as indicated in relevant SOPs’.
• Taking relevant change controls, review of change control taken by departments, follow up of the same for closure. Record control – ensuring that all records are written legible. Controlling and maintaining records in the QA department.
• Reviewing qualification and validation documents.
• Planning (including preparation of relevant audit related documents, review of documents) and performing relevant audits: study-based audits (including site audits), quality system audits, process audits, vendor audits. Prepare audit reports, review audit reports generated by peers; review corrective and preventive action plan generated and follow-up on the closure of the same.
• Conducting audits for the following vendors: Biomedical waste management, couriers, third party archival, calibration agencies, laboratory reagent suppliers; software and instrument vendors.
• Conducting system audits for the following departments: Bioanalytical Research Laboratory, Human Pharmacology Unit, Data Management and Biostatistics, Regulatory Affairs, Maintenance, IT.
• Review of relevant documents (other than SOPs’) generated – viz. protocol, testing procedures, study plan, clinical study report; and so on. Review relevant documents (qualification and validation documents) pertaining to the Computerized system. Audit relevant computerized system during study audits and system audits.
• Sharing best practices and ideas with fellow QA personnel.
• Analyzing the root-cause for non-compliance / deviations; analyze trends observed (if any) and advice on resolving issues.
• Suggesting improvement potential and best practices.
• Communicating lessons learnt to fellow QA personnel and apply the best practices across departments.
• Participating in Sponsor audits.

Work Achievements:

• Received Certificate of Appreciation "In recognition of team dedication and contribution to the company's success and many successful sponsor audits and confirmed new business" in December 2017.
• Completed Lean and Six sigma white belt certification
• Completed 'Train the Trainer on EQMS- Trackwise 9.1' in January 2019.
• Participated in the 'Workshop on ICH GCP' in August 2019.
• Completed Two days In - House training on 'Technical Writing Skills' in September 2019.