Kiranmaye Akula

As the QA Document Control Manager at Faraday Pharmaceuticals, Inc., I oversee GxP document control to support our core quality system operations. My responsibilities also include managing training programs, reviewing and approving SOPs, and evaluating quality events. This position involves handling a range of complex tasks with general supervision, all in compliance with current GxP standards. Additionally, I provide document control support for quality assurance and assist with the operational management of regulatory activities.

Primary Responsibilities:

• Performs QA document control and electronic document management system administration functions: including document login, tracking, processing, approval, distributing, and archiving.
• Coordinates the revision, review, and approval of SOPs and other documents.
• Provides training in GxP related subjects and released SOPs, as applicable.
• Responsible for SOP biennial update.
• Manages training program.
• Maintain Employee Training Files (annual audit, periodic updates)
• Interface with all groups to provide support in GxP training practices and documentation
• Develop content and format of training materials for GxP training
• Execute training program for new and existing employees
• Maintains change control and deviation processes, master batch records, specifications, test methods, validation protocols/reports, technical protocols/reports, and other GMP documents.
• Assist in GxP investigations and perform root cause analyses, as applicable
• Implement and maintain QA-GxP systems and activities
• Manage the process for development and maintenance of GxP SOPs
• Assist during FDA or other Health Authority Inspections
• Keep abreast of developments in document management by reviewing current literature, talking with colleagues, participating in educational programs, attending meetings or workshops, or participating in professional organizations or conferences.
• Assist in the Regulatory submission lifecycle (preparation to submission) using MasterControl Registration Project and/or CTIS.
• Assist in regulatory document management utilizing MasterControl and/or SharePoint, as required.
• Assist in maintaining Regulatory systems and processes (SOP related tasks, clinical trials websites monitoring, etc.)
• Accomplished multiple tasks within established timeframes.

• Joined as QA Document Specialist, contracting position in Nov 2019 and was quickly hired as full-time employee in Mar 2020 and promoted to Senior QA Specialist in 2022. Working with Quality Systems to support majorly Drug Manufacturing (all cGMP activities), Clinical, RA, Supply Chain and Commercial Teams. Played a key role in migrating from paper-based system to electronic system.

Responsibilities include:

• Manage the Quality Document Management System of drug manufacturing cGMP activities at Jaguar Health, Inc. in an EQMS (Master Control) and Online file sharing platform Egnyte at Jaguar health for both commercial and developing drug substance and drug products ensuring compliance.
• Co-ordinate document control functions to ensure version control, traceability, and security of documents, manually and in an electronic document management system (MC).
• Prepare and process SOPs and other controlled documents such as specifications, policies through document lifecycle (e.g., SOP creation, circulate for review, approval, periodic review, etc.)
• Review SOPs, specifications, forms, template, for compliance with GXPs and regulatory requirements. Work with SMEs for conceptualization.
• Create interactive forms using Life Cycle Designer
• Review GXP documentation to verify accuracy, completeness, legibility, formatting, grammar, etc.
• Review, main tracking sheets (log), and archive documentation to verify good documentation practices and ensure retention policy is followed.
• Coordinate the document change control / management of change program for controlled documents.
• Manage the training program by creating training curriculum, assign training tasks, maintain employee training files, and ensure training is up to date.
• Works with cross functional teams and stakeholders to ensure continuous improvement of processes / procedures and quality of work product.
• Participate in regulatory inspection by reviewing regulatory submissions related quality documentation and provide document logistics.
• Provide quality metrics data and overall compliance updates to senior and executive management, to meet quality metrics and management information needs.
• Review CMO Master Batch Records, executed batch records, batch release, and approve shipments for both commercial and developmental drug products.
• Played a key role in reviewing process validation documentation for developing products, addressed inconsistencies, and worked with CMOs to fix the gaps.
• Established good document management system for inspection readiness and audits.
• MasterControl: Supported implementation of Documents, Training, Process, Audit and Supplier module. Build new infocard types, creating lifecycles, custom fields, organizers (easy document navigation for end users), document uploads, continuous improvement FBS forms (revised configurations, workflows, build checklists, data structures to align with company QA systems functionality), build e-forms, creating training courses, training curriculums, job codes, assign training tasks to new employees and existing employees, handle trouble shooting by connecting with MC support team, Annual System Validation, Hands on training for end users.

• Participated in a voluntary internship in the neuro-oncology/surgery oncology program, where I digitized physical master regulatory files in accordance with federal and cancer center criteria.
• Trained on Regulatory Master Files and Clinical TMF Guidelines.
• Completed the clinical research associate and regulatory training series courses with UCSF clinical study team staff including GCP/HIPAA, OnCore, protocol reading, inform consent, regulatory file management using Complion, protocol project management, data safety and monitoring, AE and SAEs and IRB Systems (iMEDris).
• Participated in interim monitoring visits, reviewing Sponsor and Study site TMF for low Grade and High-Grade Glioblastoma studies at UCSF Medical Center.
• Reconcile monitor and sponsor queries using Rave database (metadata)
• Participated in obtaining in informed consent and patient neuro-cognitive tests using IXRS tools.
• Attended clinical trial committees and panels for human subjects, protocol review, clinical trial study conduct, tumor evaluation and observed patient safety review.
• Accomplishments:
• Hands on experience on clinical research conduct and management.
• Good understanding of patient safety and importance of GCP

• Organized healthcare article material determined the area of emphasis and wrote the content according to prescribed editorial style and format standards.
• Medical writing of patient and physician-oriented articles on “Disease and Conditions” for the online web portal.
• Enhanced the quality of writing and targeted the niche audience by using well planned search strategy, approximately key words, and credible resources with well content.

• Tracked company pipelines and collected authentic data about their products for the user interface.
• Extensively and intensively analyzed each existing pipeline and any new products on ongoing basis and from various perspectives, including financial, commercial, technical, IP/patent, generic, and life cycle management.
• Compiled data from various credible sources, such as Clinicaltrials.gov, PubMed, Food and Drug Administration, and European Medicines Evaluation Agency, to analyze and compile reports.
• Collected and entered comprehensive clinical and regulatory data into the MEDTRACK database.
• Identified and reported key industry insights and trends by analyzing information such as research publications, company press releases, U.S Securities and Exchange Commission filings, clinical trial registries, facts sheets and medical literature.
• Conducted extensive secondary research on pharmaceutical products by compiling scientific literature into client required format and updating in the company’s database as per standard operating procedures (SOP).
• Reconciled controversial client queries by collaborating with team members.

• Worked with Principal Investigator, Senior CRAs, and research team to identify subjects, develop recruitment and retention strategies, screen and enroll study subjects for Anti-anxiety and anti-depression drug Duloxetine.HCl Bioavailability studies.
• Screened study subjects for the daily clinic schedule using the update informed consent form and confirmed eligibility of potential study subjects as per the protocol.
• Scheduled study visits and necessary testing including procuring blood, urine, and serum.
• Co-ordinated, organized and maintained all study documentation including submissions, continuing reviews, amendments, and SAE/AE reporting.
• Maintained accurate records of AEs and expedited reports for SAEs.
• Supervise the clinical subject assessments, therapy delivery, and the gathering, handling, and transportation of biological specimens in accordance with the research protocol.
• Accurately collected reported data timely manner in accordance with protocol.
• Managed all day-to-day activities necessary to facilitate the successful completion each day scheduled tasks.

• Verified and documented shelf life of medications.
• Consulted with physicians and patients about medication dosage, drug interactions, disease management and potential side effects of prescription and OTC medications.
• Maintained accurate patient records, dosing information and directions for use and compliance.
• Tracked medication errors, drug interactions, and AE/SAEs.
• Handled queries for doctors, nurses, and patients.
• Improved drug inventory management system to reduce waste and eliminate back orders.
• Managed annual pharmacy budget and made budget recommendations are required.
• Managed all aspects of hospital pharmacy department with ancillary staff including medication procurement, dispense and compound prescriptions, distribution, storage, administration, patient monitoring, and pharmacy policies and procedures.

• Shadowed in tablet manufacturing and tablet coating process, reviewed documentation during the process, in-process testing, and inspection of the finished product following SOPs.
• Trained in packing of tablets and capsules and storage.

• Participated in pharmaceutical production and quality control process, tablet, syrup, and parenteral manufacturing.
• Got trained in quality control and assurance documentation, preparation of SOPs.