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Senior Business Analyst with Pharma Experience in Cambridge, MA (LOCAL ONLY) at Cambridge, New York, USA
Email: [email protected]
From:

Bhuwan Tiwari,

Sonitalentcorp

[email protected]

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Job Title-Senior Business Analyst

Location-2-3 days a week on site (Cambridge, MA)/Local 

Visa-Any Visa Except H1B,CPT,OPT

 Top Skills - Must Haves
Pharma
Data Archiving
Validation
GXP
Validation
Familiarity with Lab systems projects
Strong validation knowledge, quality expertise  data integrity/management
Good technical documentation
Good communication

Top Skills' Details

1. 8-10 years experience in a GxP environment as a Business Analyst gathering business requirements, testing, creating and writing SOP's

2. Experience working with lab and electronic systems (lab instruments, Werum, Moda) ideally supporting Quality projects

3. Experience as BA interfacing and being the liaison between the IT and Business groups

4. Experience authoring IQOQ (installation qualification and operation qualification) is nice to have

Job Description

Leads the analysis of complex business problems and manages business requirements within area of responsibilities.

Leads development of scope definition and business priority-setting.

Leads document authoring and review of GMP software validation efforts

ACCOUNTABILITIES:

Manages requirements gathering, prioritization and negotiation with business stakeholders in order to ensure the total solution delivered meets or exceeds expectations.

Maintains and influences business process design; validates and interprets business needs by conducting feasibility studies and drafting business cases.

Uses knowledge of business operations, investigates and identifies operational needs, problems and opportunities and uses Business Process Mapping to phrase and manage requirements or organizational improvements.

Ensures delivered solutions are compliant with associated federal regulations (SOX, OFCCP, labour laws, GMP, GxP, GCP, etc.).

 Is a subject matter expert in the business area of expertise and actively shares emerging industry standards/trends with customers and peers.

Establish relationships with relevant colleagues from Global Functions within the Global IS/IT Organization (PMOs, EADS and ITIO) and leads change in analysing and guiding on solutions within ongoing processes.

Additional Skills & Qualifications

-Communication is big for this group, the BA's need to be able to work with several different internal groups -IA Michelle Daunais notes: -Person needs strong documentation/requirement gathering skills

Employee Value Proposition (EVP)

Tier 1 Pharmaceutical company. Heavy interaction with stakeholders at each major group (R&D, clinical, supply chain, finance) not only here but across the globe. Highly professional consultative organization. The ability to be apart of the largest biopharmaceutical integration in history

Work Environment

External Communities Job Description

Leads the analysis of complex business problems and manages business requirements within area of responsibilities.

Leads development of scope definition and business priority-setting.

Leads document authoring and review of GMP software validation efforts

ACCOUNTABILITIES:

Manages requirements gathering, prioritization and negotiation with business stakeholders in order to ensure the total solution delivered meets or exceeds expectations.

                         Thanks, 

Bhuwan Tiwari

Sr.Technical Recruiter 

SoniTalent Corporation I

5404 Merribrook Lan--e, Prospect, KY, USA

 [email protected]

Keywords: business analyst rlang information technology Iowa Kentucky Massachusetts
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Tue Jan 16 21:58:00 UTC 2024

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