ACS Solutions has an immediate need for a QA Associate Specialist
– Document Control with experience in the Pharmaceutical Industry.
This is a 06 months opportunity and is located in New Brunswick NJ.
Our client is a leading Pharmaceutical company.Please review the job description below:Top Skills:QA SystemsDocument Controlgmp experienceKey Responsibilities:The QA Associate Specialist
– Document Control is responsible for implementing, supporting and monitoring the effectiveness of the Quality Systems and Training within the Global External Manufacturing (ExM) organization.Process Ownership:The QA Associate Specialist
– Document Control will act as end-to-end Local Process Owner of one or more Quality Systems used within Global External ManufacturingEstablish and maintain relationships and communication pathways with Global Process Owners and Global Process Leads for relevant systemsAct as primary ExM representative at Global Community of Practice meetingsGather stakeholder input from within ExM on any Global Process changes or initiatives and represent the input back into the Global NetworkOwn all elements of the process including relevant procedures / forms, training materials, SharePoint content, metrics where applicableDisplay technical knowledge of the process and understand risks/weaknesses in the systemResponsible for ensuring the elements of the process are compliant with Regulatory requirements, Health Authority expectations and with (CLIENT) policies / global procedures where applicableResponsible for ensuring the elements of the process are current and reflect current practicesBe primary subject matter expert for review of regulatory changes, responsible for coordination of input from key stakeholders into the impact assessment to the processEnsure appropriate Key Performance Indicators are in place to measure the effectiveness of the system within ExMRegularly review the process (trends metrics, trends observations, right first time (RFT), Design, optimisation) for their effectiveness and provide feedback to the Quality management team for action and remediationOwn relevant process issues
– speak to trends / issues / exceptions at External Manufacturing Tier 3A and 3B Quality CouncilOwn Health Authority commitments related to the processAct as the subject matter expert in audits / inspectionsDevelop and implement pro-active continuous improvement plans for the process for example Value Stream Mapping and identification of weak elements, regulatory surveillanceProcesses include Deviation Investigations, Corrective Action / Preventive Action (CAPA), Complaints, Change Control, Quality Risk Management, Documentation, Training, Audits & Inspections.Operations Support :The QA Associate Specialist
– Document Control will be responsible for providing day-to-day support to ExM Operations on Quality Systems that enable business objectives to be achieved.
This may include:o Processing of Customer Complaint records, including escalation of expedited complaintso Support the processing of deviation investigations, CAPAs and change controlso Perform initial impact assessment of Global change controls that may impact ExM Operationso Participate in Virtual Plant Team (VPT) meetings as appropriateo Support the risk assessment and mitigation plans of Contract Manufacturing Organizations (CMO), as requiredo Facilitate tracking of CMO Health Authority inspection observations and CAPAso Escalate any emerging trends / issues to the VPTs, as required.o Provide Quality input on ad hoc queries relating to ExM OperationsSupport metrics collection and processing, including:o Capture and report on Quality data and metrics for management review and other organizational forumso Utilize data analysis or software skills to build on existing tools to improve the quality system processeso Collect statistical data and compile data for reports; update and assure the accuracy of databases; create management reports; collect, compile, and analyse data and informationOther ad-hoc duties will be required which will include, but not be limited to, the following:o Act as team lead for coordinator of work associated with complaints, change control, deviation, CAPA and document management in the applicable ExM locationo Author, review and approve Quality Management System (QMS) documentso Process QMS documents in the electronic document management systemo Participate in and support Permanent Inspection Readiness activitieso Maintain the Quality Risk Register for ExMo Monitor the periodic review of Quality Systems documentso Maintain the system and process for record managemento Maintain the system for update of ExM GxP (Good Practice) Authorizationso Act as facilitator and reviewer of global procedural updates through the GPO networko Act as ExM Quality Systems representative on ExM and Global Quality projectso Support the scheduling, execution, reporting, follow up and tracking of self-inspections auditso Support preparation of and participate in Quality Council meetingso Perform self-inspection audits as part of the audit teamo Review regulatory inspection observations from other CLIENT sites for site complianceo Identify and implement continuous improvement opportunities for Quality Systems owned processeso Act as qualified training for Quality Systems owned processesContingency Support:Quality Systems Senior Specialist, other Quality System Managers :Required Competencies Essential:Works under minimum supervision and exhibits a positive work attitude and high productivityDetail-oriented, well organised and have excellent verbal and written communication skills as well as excellent organization and follow-up skillsCandidate must be flexible and comfortable working in a fast-paced environment with aggressive and dynamic timelinesExcellent interpersonal skillsAbility to collaborate, facilitate, and support standard practices across multiple functional groups in diverse geographical locations are required; self-motivatedStrong presentation skills; confident public speakerAbility to multi-task numerous projectsAbility to achieve targets and milestonesCan prioritize workload based on changing business needsAbility to recognize topics / decisions requiring escalationAbility to work with initiative and manage own workloadProficient in the use of Microsoft Office programs including OneNote and SharePoint platformsFluent English is required.
For roles based in Switzerland, German is also desired.Strong working knowledge of Microsoft OfficeIf it creates an interest for you, please email me the latest copy of your resume, through this posting.Thanks & Regards,CHARU?
YADAVLead ?
Recruitment at ACS SolutionsA: 2400 Meadowbrook Parkway, Duluth, GA 30096P: (1) 208-929-4341 ABOUT ACS Solutions.ACS Solutions is a global provider of information technology solutions, talent solutions and workforce management services.
Our Industry vertical based domain expertise, passion for innovation, combined with the power of technologies in cognitive sciences, cloud computing, data sciences, product engineering, robotic process automation, machine learning, and block chain, helps clients envision, build and run their businesses more efficiently.
Headquartered in the US, ACS Solutions has grown to over $1.2 BN.ACS Solutions is a Certified MBE by the Georgia National Minority Supplier Development Council.ACS solutions has multiple subsidiaries, each focused on the unique area of business:Analysts international Corporation (Staff Augmentation Services)The Ascent Services Group Inc.
(Life Sciences Talent Solutions)HireGenics, (Payrolling, IC Compliance, & MSP Services)DATA Inc.
(Information Technology
– staffing)Recent Awards and Recognitions:6th largest IT staffing firm in the US.
(Staffing Industry Analysts (SIA) 2019)Largest Minority IT Staffing Firm in the US.
(SIA 2019)ClearlyRated® 2020 Best of Staffing award winner for providing remarkable service quality to our clients.
This is our ninth consecutive win.IT and Industry certifications:Microsoft Gold Partner: Application Development, Cloud Platform, Data Analytics, Data Center, DevOps, Data PlatformAWS Managed Services PartnerGoogle Cloud PartnerISO 27001:2013 Certified for Data SecurityISTQB Gold PartnerISMS (ISO 27001:2017)SOC2 Type II Compliant