Customer Service Document Control
Resume:
P
PayalPatel
*******.*****@*****.***
Bensalem, PA 19020
SUMMARY
Dedicated administrative professional with experience in popular systems and software. Friendly employee with strong ethics and issue resolution skills. Computer-savvy and willing to learn to handle diverse office needs. Excels under pressure and flexes easily with changing demands. Highly- motivated employee with desire to take on new challenges. Strong work ethic, adaptability and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills. Hardworking employee with customer service, multitasking and time management abilities. Committed job seeker with a history of meeting company needs with consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand. Organized and motivated employee eager to apply time management and organizational skills in various environments. SKILLS
Data Accuracy
Standard Operating Procedures
Process Auditing
Regulatory Compliance
File Documentation
Compliance Controls
Process Improvements
EDMS
File Migrations and Audits
Document Distribution
EXPERIENCE
QA Document Control Specialist
VasuTech Medical Oaks, PA/Jan 2024
Conduct general document management activities such as review prior to filing to ensure compliance.
Perform batch release activities, reviewing and approving manufacturing batch records, reviewing certificates of analysis & other documentation for medical devices.
Generate certificates of releases, create. lots in electronic system & also upload all documents for medical devices.
Maintain accurate and organized records of all quality assurance and batch disposition activities.
Collaborate with cross-functional teams to resolve quality-related issues and ensure timely release of products.
Working knowledge of QT9 electronic system.
Working knowledge of ISO 13485 and also familiar with other regulatory requirements applicable to medical device manufacturing.
Support company goals and objectives, policies, and procedures, and quality System Regulations.
Provide efficient and reliable support services within the Quality department with responsibilities including and not limited to, coordinating all aspects of document control activities.
Manage the oversight for documented flow of controlled documentation for the Document Storage Room.
Assist with Audit activities including and not limited to audit preparedness, generating indices and reports, note-taking, collection of requested documents and supporting the Auditor for any other tasks as may be required.
Reviewing and approving material specification according to AQL for medical device products.
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QA Document Control Specialist
CMIC CMO USA Cranbury, NJ/Feb 2023 to Oct 2023
Review batch, follow proper GMP documentation practices and prepare them for product release, reviewing certificates of analysis & other documentation for drug product.
Performing final review and release of finished product.
Ensuring all Nonconformance, deviations & OOS documented reported in the batch records.
Review and maintain the accuracy of the records, editing where necessary to ensure they are up to date
Develop and manage spreadsheets and databases containing document adhering to Good Manufacturing Practice (GMP) and Site Standard Operating Procedures (SOPs).
Working knowledge of ACE Essentials system
Knowledgeable on cGMP's, 21 CFR Parts 210 & 211
Maintaining and issuing SOPs, Master Batch records, CAPA, Change control, Deviations and Protocols
Manage the processes around documentation within the organisation
Maintain confidentiality around sensitive documentation. Packaging/ Manufacturing Operations Associate
KVK Tech Newtown, PA/Aug 2022 to Jan 2023
Primary responsibility is to provide technical writing support to Operations and to assist Operations
Monitoring of departmental activities to ensure they are being performed in compliance with SOPs, GMPs, GDPs and ALCOA
Assist with the review, tracking, GMP compliance and approval of Change Controls for Production, Processes, Facilities and Equipment, maintaining logbooks.
Participate in developing, writing and reviewing qualification documents and updating SOP's and related forms
Design, develop and implement databases to track key project deliverables and resource allocation within Packaging/ Manufacturing and update on an ongoing basis
Initiate and manage process improvement activities based upon gathered data or as a result of investigations or other activities
Assist with and perform investigation and technical writing activities in the Packaging areas
Monitor and facilitate training of departmental personnel including one-on-one training, group training and on-the-job training and in managing relevant training documentation
Packaging/ Manufacturing Document Reviewer
KVK Tech Newtown, PA/Jan 2020 to Jul 2022
Certified Packaging / Manufacturing Document Reviewer for a company performing manufacture, packaging and distribution of pharmaceutical products
Complete reviews and edits of draft Master Batch Records, forms, cleaning checklists etc
Perform in-process audits of packaging/ Manufacturing rooms, documentation and logbooks to verify compliance with SOPs, GDPs, GMPs and ALCOA standards
Review completed batch documentation including batch records, setup sheets, inspection records etc
To confirm instructions and procedures have been followed and documents adhere to GDPs and ALCOA and to verify all operations meet batch record specifications
Execute transactions in Syspro inventory management system for allocation and return of materials and tracking of product yields and reconciliations
Knowledge of Master Control system.
Clerk
Data Core SystemsBristol, PA/Dec 2019 to Jan 2020
Teacher
Vrajbhoomi International School, MogarIndia/Apr 2011 to Oct 2019
Math Subject Teacher (Taught in Preschool and Grade 2)
Class Teacher for Grade 2
Created and implemented innovative teaching process
Creating progress reports and presenting to parents
Instructed students with learning disabilities.
EDUCATION
Masters in Commerce
Dr. Harisingh Gaur UniversityJun 2000
Sagar, Madhya Pradesh, India
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