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Search 2 million Resumes Keywords: City or Zip:	Related Resumes Pharmacy Technician Quality Control Philadelphia, PA Quality Assurance Pharmacy Manager Philadelphia, PA Quality Control Management System Willingboro, NJ Customer Service Quality Assurance Norristown, PA Quality Control Supervisor Bear, DE Pharmacy Technician Front Desk Atco, SC Quality Assurance Control Narberth, PA

Profile SummaryQuality Auditor with a masters degree and 3 years of experience in Quality, Compliance, and Regulatory Aspects of the Pharmaceutical Industry. Having responsibility for Quality Systems, Corrective and Preventive Action (CAPA), Risk Management, 21 CFR Part 11 Regulation, Document Management (Veeva Vault) and Process Management . Problem solver and detail oriented. Excellent interpersonal and communication skills. Results-driven, a skilled leader focused on achieving success and increased productivity through improvements in operations, quality, and safety.Professional Experience:Ability to handle multiple projects, and work independently, Quick learning ability, good verbal, writing, and analytical skills.Experience in Pharmaceutical Industry and Healthcare with knowledge related to regulatory bodies, process, software usage like automated testing frameworks, test plans, tracking and reporting defects.Ability to provide guidance, lead/co-lead projects, manage time to meet objectives, and plan resource requirements for projects across the department.Ability to make Risk-based Quality decisions impacting products and services.Excellent working knowledge, understanding, and experience with the practical implementation of local laws, FDA, EU, EMA, ICH regulations, and industry guidelines.Knowledge and Experience in Pharmaceutical and Bio-pharmaceutical Manufacturing.Performs audits (both project and non-project related) to assure the compliance of the operations to GCP/GLP, SOPs, regulatory requirements of the following departments wherever applicable; Bio analytical operation/Pharmacokinetic unit, Quality assurance unit and other general divisional operations.Conducts in process surveillance (both project and non-project related) to assure ongoing compliance of the bio analytical operation/others as applicable.Experience in preparing the QA audit reports for raw data, analytical data (method development and validation), instruments maintenance, SOPs revisions, sample storages and surveillance performed.Bio studies reviews which involve:Data is stored, retrieved, and manipulated correctly in a database. This includes checking data integrity, accuracy, and ensuring that queries perform as expected.Defect tracking involves identifying, documenting, and managing issues or defects found during the testing process. Tools like AQRS often include defect tracking features to facilitate the communication and resolution of issues.Experience using Doc Compliance (Veeva vault).Experience in USFDA audits.Experience applying proactive quality approaches for analytical and clinical data.Ability to Drive effective management of Quality issues and Corrective Action Plan (CAPAs) and make decisions that may involve complex quality and technical issues.Ability to ensure quality systems, processes, specifications, and SOPs are designed to be appropriate for the development, manufacture, testing, and timely release and distribution of quality products, and consistent with global quality strategy and meet all relevant regulatory requirements including local and international regulations and applicable standards and guidelines.Ability to provide support to the product complaint system through; leading and managing product complaint investigations, performing data analysis, and trending of compliant information to proactively detect the signal and take appropriate actions in a timely manner.Collaborates with R&D and Local Product Supply teams to ensure product demand forecasts are maintained and updated to reflect current needs for adequate supply of active studies.Collaborates closely with Scientific Review Committee providing necessary information and support to ensure compliant, timely, efficient reviews of concepts, protocols, and protocol amendments, IRB approvals.Ability to establish and streamline the site change control process.Supports safety updates and Dear Investigator Letters (DILs).Ability to elevate organizational performance by partnering with stakeholders and operating within and across multiple regions and cross-functional departments.Proficient in coordinating department preparation and initiatives for inspection readiness.Performs all work in accordance with all established regulatory and compliance and safety requirements.Ability to handle multiple projects, work independently, Quick learning ability, good verbal, writing and analytical skills.Work experience:QA Analyst, Alithya Datum Consulting Groups. 09/2023 -01/2024Responsibilities:Perform reviewing of Insurance check using Rapid capture solution that will accurately extract, normalize and validate information from returned mail and output the results into an accessible format.To improve the handling of returned mail and minimize occurrence of undeliverable mail we are performing QA and manual review processing of documents within Rapid Capture.Created comprehensive test cases based on requirements and design specifications.Developed and executed test plans, ensuring thorough coverage of functional and non-functional requirements.Collaborated with cross-functional teams to review and validate test cases, ensuring accuracy and completeness.Tracked and reported defects through their life cycle, from discovery to resolution.Worked closely with development teams to provide detailed information for efficient defect resolution.Facilitated regular communication between development and testing teams to enhance collaboration.Conducted knowledge sharing sessions on test automation best practices and tools.Identified opportunities for process improvement and implemented changes to enhance overall testing efficiency.Participated in retrospectives to analyze testing processes and suggest improvements.QA Auditor, Apotex Research Private Limited, Bengaluru, India. 07/2014  12/2016Responsibilities:Prepares QA Audit reports and presents audit findings and/or other related information at departmental, internal operations, or client meetings.Involved in the preparation, conduct, and reporting of internal systems audits, internal locations audits, and vendor qualification audits.Review the daily activity forms & logbooks.Coordinate department preparation and initiatives for inspection readiness.Assist with department coordination during audits.Track departmental quality records and communicate with the department and stakeholders.Works to resolve Deviations, Investigation reports, involved in root cause analysis and CAPAs.Responsible for providing quality oversight to the change management system for change controls. This includes plan creation oversight, verifying that changes adhere to SOPs, and regulatory compliance.Responsible for creating new SOPs and revising the existing documents (SOP, Forms, Work Instructions, etc.) to comply with the electronic systems.Ensures that assigned work is performed in accordance with GxP, HSE, OSHA, FDA, regulatory requirements, best practices, and established safety standards.Knowledge of Medical Investigator Sponsored Studies program requirements and understanding of the external environment and regulations that impact the conduct of such programs, including GCP, ICH standards, OIG, PhRMA code to ensure ethical and responsible conduct.Provide Data Integrity reviews for data associated with product impact assessments, technical evaluations, and scientific investigations.Aware of Training Master database application in citrix, ensures stakeholders are trained.Manages the overall study operational activities from initial proposal submission to study closeout includingContributes to program audit readiness and provides accurate and rapid responses to audit inquiries.Collaborates cross-functionally to ensure efficient and timely delivery of research agreements, product supply, COA of products, purchase orders and other deliverables.Providing necessary information and support to ensure compliant, timely, efficient reviews of concepts, protocols, and protocol amendments.Ensures study updates are collected, documented, tracked, and communicated to stakeholders.Maintains data integrity by enforcing standards, controls & permissions. Works with system vendor and Systems & Process Operation team on issue resolution and enhancements.Principles for the conduct of clinical trials, emphasizing the importance of patient safety, data integrity, and compliance with regulatory requirements. Aware of guidelines established by the Pharmaceutical Research and Manufacturers of America (PhRMA).Experience in Audit trails, Veeva vault, AQRS, Eurotherm, Watson LIMS, Enterprise pharmacology.Experience using Doc Compliance), Process Compliance, and BMRAM.Knowledge in Base SAS.Coordinate data review assignments.Assist with departmental improvement projects.Educational qualifications:Masters in pharmacy (M. Pharm) from Rajiv Gandhi University of Health Sciences during the period 2012  2014.