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3024 : Electronic Batch Record (EBR) Consultant

Company: E-solutions Inc
Location: Andover
Posted on: November 18, 2018

Job Description:

Job Title: EBR Consultant Job location: Andover, MA Job Duration: Fulltime/Contract Mandatory skills: Sound experience and knowledge working on Rockwell MES FTPC (Factory Talk Pharma Suite) for Modelling Manufacturing Processes in Pharmaceutical industry. Ability to understand Master Batch Records and create design/functional specifications for MES system Experience working on creating / revising Electronic Batch Record (EBR) based on product version or process changes Pharmaceutical Manufacturing exposure Knowledge of Manufacturing IT systems, IT standards like S88 batch model, ISA 95, GAMP 5.0, 21 CFR Part 11, etc Preferred Skills: Knowledge of Manufacturing Execution Systems (preferably, PMX/FTPC/FTPS from Rockwell) and Control Systems Site MES deployment experience Biotech process knowledge Job Role: Understand batch records and deliver a standard recipe in MES (AMPS) solution leveraging operation building blocks Train and mentor site recipe authors on MES (AMPS) EBR recipe life cycle (including analysis, authoring, testing, validation, documentation and support) Support site during go-live transition and post implementation Site specific requirement analysis and functional specification development (if required) Interaction with client SMEs to discuss and understand these processes Preparing ---To-Be--- and ---As-Is--- process flows from deployment/ landscape perspective Identify AMPS Operation building blocks to author Master Recipes Author and configure MES (AMPS) master recipe Test, validate and demonstrate master recipes Assistance with system SOPs Participate in IQ (if req, OQ and PQ Impart end user training on new recipes and post go live support 13 Mentor site Master Recipe authors through EBR recipe life cycle Liaise with technical team on complex problems to provide resolution Thanks & Regards, Pavan Singh Sr. Technical Recruiter Tel email : (e-Solutions provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. We especially invite women, minorities, veterans, and individuals with disabilities to apply. EEO/AA/M/F/Vet/Disability)

Keywords: E-solutions Inc, Boston , 3024 : Electronic Batch Record (EBR) Consultant, IT / Software / Systems , Andover, Massachusetts

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