What Does A Senior Specialist Quality Assurance Do At Merck
* Provide QA support for the GxP computerized systems to ensure the maintenance of compliance of the IT GxP Quality Program.* Perform critical review of computer system validations and equipment qualifications in reference to internal and external standards.* Provide support for planning, coordination, performance and documentation of both internal and external audits in line with appropriate requirements.* Administer and maintain QA related electronic systems (Sharepoint, EDMS, and training systems). * Maintain an efficient document management system for controlled documents.* Maintain documentation of QA tasks in compliance with associated requirements and internal SOPs.* Provide support for global QA initiatives and keep current on IT QA trends globally.* Communicate across R&D QA team and foster a productive and efficient team environment
What Does A Senior Specialist Quality Assurance Do At Henry Schein, Inc.
* _* Typically responsible for two or more of the following duties:* Research and analyze applicable laws and regulations; develop and implement the necessary policies and procedures to ensure the Company’s ongoing compliance with Federal, State and local requirements.* Implement systems and processes needed to ensure compliance with the receipt, storage and distribution of medical devices.* Conduct periodic audits on facilities and customer site visits to assess levels of compliance and risk.* Monitor compliance with DOT requirements for the classification, storage and distribution of Hazardous Materials; as well as the activities to comply with environmental laws, including the registration and disposal of pesticides and other type of type of chemical products.* Coordinate the implementation of systems and procedures to ensure compliance with OSHA regulations.* Support Distribution Center management and designated staff on the actions necessary to maintain regulatory compliance.* Provide support during government inspections and formulating the appropriate response and corrective actions.* Develop appropriate awareness and training programs for TSMs consistent with regulatory compliance policies and procedures.* Conduct routine Regulatory audits of Henry Schein facilities, affiliates and subsidiaries.* Conduct Quality Assurance Audits as scheduled and ensure the effective and timely facilitation of suppliers and internal quality audits and follow-up on CAPAs/observations.* Stay current with new or potential business opportunities and prepare for all QA Activities.* Research applicable FDA, ISO standards to ensure the company’s ongoing compliance with the U* S. and International Regulatory requirements (Medical Devices Directives and FDA QS Requirements).* Approve packaging/labels for all private label products to assure compliance with regulatory requirements.* Participate in special projects and perform other duties as required.* TRAVEL
What Does A Senior Specialist Quality Assurance Do At Catalent Pharma Solutions
* Provide oversight to ensure the Quality Systems are maintained in compliance with regulatory and customer requirements.* Maintains and enhances effectiveness of the Quality System, including identification and implementation of improvement opportunities for established Quality Systems, processes, procedures, and training to support CAPA, Change Control, Risk Management, and Deviation processes.* Accountable for the execution of the Internal Audit program. * Responsible for managing customer audits, including coordination of the audit with the customer and internal Catalent stakeholders, hosting audits and providing accurate information regarding the Quality Management Systems and Catalent operations, and oversight of the audit response and follow up actions required by Catalent. * Conduct audits of suppliers and vendors to support the Supplier Quality Assurance program. * Drives alignment and improvement initiatives, leading cross function teams, to address process improvement, system improvement, and new regulations/expectations.* Responsible for maintaining a sufficient understanding of the Quality Management Systems and operations to provide oversight and decision making as appropriate in the absence of the QA Systems Supervisor. * Maintains data integrity and ensure compliance with company SOP’s, specifications; as well as cGMP, ICH, FDA, EMA regulations or guidelines.* Provides technical assistance and training for personnel.* Files and maintains controlled documents.* Other duties as assigned.* III
What Does A Senior Specialist Quality Assurance Do At Merck
* Supportthe development, implementation, and maintenance of critical processesvia systems support such as Deviation Management, Product Release, documentationcollaboration, metrics, Change Control, including managing associatedmaster data* Provideongoing production / master data support ensuring EQA data and processesrun smoothly with no interruption to supply* Functionindependently and exercise leadership to identify and implementimprovements to existing business processes and systems; establish newor improved processes, tools, and systems and drive consistent, standardbusiness processes across EQA* Maintainand provide expertise on EQA systems, tools, data, and processes on anongoing basis, such as COMET SAP / RCT, Supplier Transparency, GCM,Orion, RCAM, Tracelink, etc.* Serve as the systems / process SME forassigned processes when IT and Business Systems representation isneeded.* Supportthe implementation of strategic projects (e.g., QSIP)* Responsiblefor developing / maintaining / and delivery of training materials andjob aids* Assistin the preparation and coordination of Senior Management presentations* Assurecompliance with established policies/procedures of the Division andCorporation and complies with all applicable governmental regulations(GMP, etc.), both domestic and foreign.* Operate in a safe and efficient manner and incompliance with the MMD QO Safety and Health Policy