IT Quality Analyst for Commercial Applications -GAMP 5- ANALYST - CONTRACT OPPORTUNITY

Hi,

We are seeking Analysts with GAMP 5 experience for our direct client- a pharmaceutical giant in Weston, MA. If interested in this opportunity kindly send updated resume to [email protected] and please call me at 732 549 2660.

TITLE: IT Quality Analyst for Commercial Applications

Contract : 3- 6 months

Location: Weston, MA

Client: Pharmaceutical company

I. GENERAL SUMMARY:
As a member of the IT Quality & Regulatory Compliance team, the IT Quality Analyst for Commercial Applications helps to define, plan, and perform duties that support major system development life cycle activities, including validation review and change control approval of IT Commercial systems.
II. PRINCIPAL DUTIES & RESPONSIBILITIES:
• Approve system life cycle deliverables and activities to ensure that procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support SDLC activities for IT Commercial systems.
• Represent IT Quality & Regulatory Compliance on all IT Commercial projects in support of SDLC activities.
• Consult on the authoring and conformance of SDLC deliverables and activities in regard to corporate SOPs and current regulations.
• Provide guidance, training, and support to IT Commercial personnel in their SDLC efforts, to ensure compliance.
• Provide quality assurance oversight for system related issues
• Assist in the completion of Change Control activities according to theclient standards.
III. JOB DEMANDS:
This job requires the IT Quality Analyst for Commercial Applications to attend department and user meetings, system assessment meetings, trainings, and other essential tasks. The IT Commercial Regulatory Analyst must maintain a professional manner in representing the company and in working with its agents and associates. The IT Commercial Regulatory Analyst should demonstrate initiative and self-direction while also knowing when to seek assistance. This person must also be able to routinely schedule and complete multiple tasks and be timeline driven.
IV. JOB IMPACT:
The IT Quality Analyst for Commercial Applications’ role is essential in maintaining IT Commercial Systems that are compliant with corporate requirements and good business practices.
IV. QUALIFICATIONS:
A. Essential:
• Thorough knowledge of IT Controls methodologies, including GAMP5 and ITIL
• Extensive experience with IT Commercial Applications (e.g. CRM systems, Salesforce, etc.)
• Strong knowledge of SDLC Agile methodology
• Experience with Veeva CRM and other systems
• Excellent communication skills, both verbal and written
• Detailed knowledge of the IT system development life cycle and software quality assurance in a regulated environment
• Knowledge of general software and database concepts
• Knowledge of infrastructure technology and platforms
• The ability to work both independently and with teams at various levels in the organization
• The ability to work in a very dynamic environment with a clear sense of urgency.
• Excellent organizational skills and attention to detail and accuracy
• Three or more years working in an IT SQA or Quality role
Note: This description is not intended to be all-inclusive or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Thanks,

Srilatha (Sri) Vinjamuri

Technical Recruiter

INTEGRATED RESOURCES, INC.

4 Ethel Road, Suite 403B

Edison, NJ  08817

IT   REHAB   CLINICAL   NURSING

Inc. 5000 – 2007- 2013 (7th Year)

Direct: (732) 549 2660

Tel: (732) 549-2030 x 127

Fax: (732) 549-5549

mailto:[email protected]

http://www.irionline.com

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