{JAVA_EJB_RMI_jobs}, Looking For ||Senior QA Specialist for BTQ&C || Memphis, TN ||

Hi Folks,
Kindly send me resume and your updated HOTLIST   at "agupta@dyssinc.com"
=============================================================

Job Title:         Senior QA Specialist for BTQ&C  (Pharma Experience)
Location:         Memphis, TN
Duration:         6+ Months

Relevant Experience (Yrs)	:	At-least 5 years experience in IT organization with 3+ years in Quality and Compliance related activities in the pharmaceutical or biotech industries supporting IT initiatives
Technical/Functional Skills	:	Excellent  understanding of Quality & Compliance in an IT environment Experience in pharmaceutical industry in IT divisions. Familiarity with Pharma-IT tools/systems Aptitude in Information Technology, performing computer system validation activities, including authoring/review/approval of computer system validation deliverables, including  requirements gathering, test plans, test scripts/cases, traceability, and summaries Experience and knowledge of software development life cycle Strong knowledge and proven experience  in Investigational processes, problem solving and root cause analysis are a must Exposure to Regulatory inspections including interactions Sound knowledge of SOX, GxP related processes
Experience Required	:	Experience in the pharmaceutical or biotech industries supporting IT initiatives Demonstrated skills for independently guiding quality and compliance activities during system development and implementation Experience in Information Technology, performing computer system validation activities, including authoring/review/approval of computer system validation deliverables, including  requirements gathering, test plans, test scripts/cases, traceability, and summaries. Ability to work independently, manage multiple priorities, and work in an unstructured environment Experience managing activities within medium to large scale IT projects Excellent oral and written communication skills Experience in SOX and GxP processes in case of critical regulatory applications Experience in providing consultancy to various teams related to quality & compliance of the managed products, including providing guidance (answering questions, addressing compliance issues) on the governing enterprise life cycle to the project teams as appropriate
Roles & Responsibilities	:	Working closely in project related decision making and completing impact and risk analysis related to quality and compliance Providing support to the Business Line / Project Manager and teams for quality & compliance input to projects Interacting with Project team and Business Representatives to understand the scope and purpose of the business process work stream Provide consultancy to BT teams related to quality and compliance of BT managed projects. This includes providing guidance (answering questions, addressing compliance issues) on the governing enterprise life cycle to the project teams as appropriate. Review / approve BT enterprise life cycle records requiring BTQA approval for projects, such as plans, requirements, testing documents, deviations, and summaries. Author documentation as required. Initiate or review and approve Compliance Risk Profiles of High or Medium compliance risk category. Work closely with Document Coordinators in ensuring the  documents get approved and uploaded to the correct folder in Gnosis (BT Records Repository) Work closely with the Project Manager and Technical Writer to complete the Tailoring form and scale deliverables (as needed) Review Test cases and Traceability Matrix very closely ensuring compliance requirements are tested ( if in scope) Providing oversight that compliance requirements are analyzed and met or deviations raised for the managed products Assisting the project team to apply the  ensuring appropriate level of documentation and evidence of following the industry standard life-cycle is generated Completing review of compliance requirement in required systems and industry standard life-cycle documentation to ensure status of requirements are correctly dispositioned (i.e. "met" / "not met") and any deviations are agreed and correctly recorded Assisting the project teams in SOX and GxP processes in case of critical regulatory applications Collaborating with Business Unit Quality Assurance and corporate teams representatives for impact to projects when medium or high risk data (GxP, SOX, Data Privacy, etc) has been identified Ensuring  that all Regulated Systems are Audit/Inspection ready
Generic Managerial Skills	:	Working with multicultural, cross-functional work teams Excellent oral and written communication skills Demonstrated ability to communicate and negotiate with individuals and groups at multiple levels across the organization Demonstrated skills for independently guiding quality and compliance activities during system development and implementation within medium to large scale IT projects Advancing a quality culture in a manufacturing environment
Education	:	BS/BA in Engineering/ Biology/Microbiology/ Chemistry/ Biochemistry/ Pharmacy

Thanks and Regards

Ashok Gupta

Direct Number : 415-259-4541
agupta@dyssinc.com

--
You received this message because you are subscribed to the Google Groups "JAVA_EJB_RMI_jobs" group.
To post to this group, send email to java_ejb_rmi_jobs@googlegroups.com.
To unsubscribe from this group, send email to java_ejb_rmi_jobs+unsubscribe@googlegroups.com.
For more options, visit this group at http://groups.google.com/group/java_ejb_rmi_jobs?hl=en.