Sr. QA/RA Associate
Resume:
Summary
§*+ years of quality assurance and regulatory affairs experience in the pharmaceutical industry
§Extensive knowledge on site's manufacturing processes and procedures. Proficient in reviewing deviations, CAPA, change controls, work orders, protocols, reports, batch records, and other GMP documents.
§Working knowledge of SAP application in releasing materials and batches throughout the manufacturing process, creating and maintaining BOM, releasing BOM for usage, maintaining vendor data using SAP application.
Professional Experience:
Ingenus Pharmaceuticals NJ, LLC Senior Associate – QA/RA Feb 2016 – Till Date
Roles and Responsibilities:
Regulatory Affairs:
§Preparing regulatory submissions such as Annual reports and Annual product review.
§Reviewing test procedures and specifications in accordance with FDA.
§Reviewing Manufacturers & outside testing lab information required for ANDA filling
§Reviewing stability compilation and executed batch records.
§Providing Regulatory compliance support in the development, revision, review, and approval of labeling content for regulatory submission, as well as any post marketing labeling changes.
§Reviewing new and revised labeling for accuracy and for appropriate regulatory requirements.
§Liaising with Regulatory Affairs members and other cross-functional teams (e.g., supply chain, legal, medical, pharmacovigilance) to ensure the accuracy of all information included on the label.
§Providing the RA compliance approval on labeling review process steps and coordinate with other Regulatory functions during the submission, approval, and notification of new/revised labeling content.
§Reviewing all labeling materials in accordance with company policies, procedures, and technologies.
§Support in revision of Labeling SOPs and reference documents and make sure it is aligning with current regulations and company policies.
§Assists in compiling and completing high quality ANDAs and Amendments ensuring final submission meets the requirements of ANDA checklist recommended by US FDA.
§Supporting all submissions and projects, ensuring tasks are completed within the expected timeline and standards.
§Coordinating and reviewing with external vendors for project support activities including Residual solvent statements, TSE/BSE statements, Melamine free certificates, cGMP certificates, debarment certificates, US agent letters, DMF LOAs, technical data sheets and drawings.
§Following up with purchase team for DMFs and necessary information required from the manufacturer for the filling
§Initiating or contributing to local process improvements, which impacts the working of regulatory affairs functions and other departments.
Quality Assurance:
§Documenting SOP’s and recommending SOP revisions for the quality operations and other departments
§Responsible for QA compliance processes, including coordination of day to day activity, maintenance of associated documentation, participation of process enhancement and training new users.
§Reviewing and maintaining Emplyoees Training Records from different departments in the database.
§Conduct annual cGMP training on routine basis and as per the company policy.
§Support in FDA inspections to provide required documents and tracking of the FDA inspection dossiers.
§Preparing and tracking of stability protocols and compilations required for ANDA filling.
§Charging and pulling the stability samples at regular intervals for testing as per the stability protocols.
§Liaising with internal departments and corporate RA and QA to obtain dossiers required for registrations or other regulatory submissions.
§Reviewing, tracking and closing of deviations, Investigations and CMC change controls.
§Reviewing and tracking of work orders and batch records, protocols and reports.
§Reviewing documentation including batch logs, training records, shipments etc. for accuracy, completeness and adherence to cGMP’s.
§Issuance and managing the Laboratory Note Books .
§Review of Vendor Qualification and reduced testing (Skip testing) reports.
§Releasing materials and batches throughout the manufacturing process, creating and maintaining BOM, releasing BOM for usage, maintaining vendor data using SAP application
§Proficient in using Microsoft Office Suite, Adobe Acrobat, SAP and Pragma WFM software.
Private Practitioner, India Physical Therapist 2009-2013
Roles and Responsibilities:
§Worked with a reputed surgeons on post-operative treatments
§Treated patients suffering from debilitating conditions such as back pain, arthritis, fractures, sports injuries, head injuries, strokes, cerebral palsy etc.
§Reviewed physician referral and patient medical records to formulate an accurate diagnosis and best course of treatment.
§Recommended equipment and in home modifications.
§Documented patients' progress and completed discharge summaries, home-program treatment plans and other forms for intra-/extra-agency personnel. Ensured all documentation was clear, concise, timely, accurate and complete.
§Supervised clinical staff and equipped them with information necessary to provide quality patient care.
§Logged patient’s details in the system to generate the invoice and complete the transaction.
Jehangir Hospital (Apollo Group), India Physical Therapist 2008-2009
Roles and Responsibilities:
§Provided physical therapy services for a specialized acute-care hospital.
§Assessed patients' rehabilitative needs, developed patient plan for care and treatment goals and conducted physician-prescribed PT programs for medically complex patients (children and geriatric).
§Restored function for patients and prevented/lessened disabilities following disease or profound injury (including loss of limb, traumatic brain injury, stroke, lymphoma and paralysis).
§Planned and administered treatments, modalities and therapeutic exercise programs encompassing active and passive ranges of motion, muscle reeducation, massage and heat/water/ice/electrical/light stimulation.
§Instructed patients in the safe and effective use of pulleys, weights, inclined surfaces and other equipment prescribed for their treatment. Participated in wound-care treatment and helped patients adapt to the use of wheelchairs, braces, canes, crutches and prosthetic/orthotic devices.
§Trained and supervised interns in all physical-rehabilitation-therapy treatments
§Provided comprehensive training in PT techniques to nursing and other medical personnel as well as family members of patients.
§Excelled in ability to customize/adapt conventional PT techniques to meet the special needs of individual patients.
§Managed a high-volume caseload and organized the daily schedules of PT assistants and patients.
VLCC, India Physical Therapist 2006-2007
Roles and Responsibilities:
§Established Ajmer branch of VLCC (Beauty and Health Services) for the franchise.
§Treated VLCC clients to overcome the problems and taught various strengthening and stretching exercises required.
§Maintained inventory of store products by anticipating needed supplies; placing and expediting orders for supplies and verifying receipt of supplies
§Registered new customers and updated existing customer demographics by collecting detailed customer information including personal and financial information
§Responded to customers, prospective customer, and visitor inquiries in a courteous manner
Education 2001-2006
Bachelor of Physical Therapy
Mahatma Gandhi Memorial Medical College
Devi Ahilya Vishwa Vidhyalaya University, Indore, India
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