• US Citizen

• Green Card

• Corp-Corp

• W2-Permanent

• W2-Contract

• Contract to Hire

• Consulting/Contract

• UG :- - Not Required

• PG :- - Not Required

• No of position :- ( 1 )

• Post :- 24th Jan 2024

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 (PMO’s, 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.