100% REMOTE || IT BSA WITH VEEVA VAULT AND CSV EXP || 12 MONTHS CONTRACT
nadeem it recruiter
<itrecruiternadeem@gmail.com>Hello,
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Please let me know if you are interested in our role with the client below.
Please share your updated resume.
IT Business Systems Analyst WITH VEEVA VAULT AND CSV EXP
100% REMOTE
12 MONTHS CONTRACT
Company Information: At Apellis, we are committed to developing transformative therapies for people living with a broad range of debilitating diseases by controlling complement, part of the body’s immune system. Our work is rooted centrally at C3, which is the only target in the complement cascade that addresses all three pathways that can drive disease. Targeting C3 has broad platform potential to treat many diseases where patients have few or no treatment options available. Our programs across ophthalmology, nephrology, hematology, and neurology are further exploring what is possible by targeting C3.
Position Summary:
The role will be responsible for gathering and documenting business process
definition/documentation, and GxP system support management. Position will
focus on business process documentation and business requirements and
supporting Quality business solutions.
Key Responsibilities:
- Document business needs and identify solutions that align to overall business strategies. Review, analyze, and evaluate business systems for their applicability to identified user needs.
- Represents IT in collaboration with Quality Validation and business stakeholders to determine computer system validation (CSV) impact, requirements, and artifacts. Executes and facilitates GxP Computer System Validation activities for IT, including implementation, validation, maintenance.
- CSV documentation including System Change Control, Impact Assessments, Validation Plan, User Requirements and/or Specifications, UAT Scripts, Traceability Matrix, Validation Summary Report, etc.
- Support and maintain procedures and operational support processes.
- Identify and troubleshoot operational issues and system issues.
Skills, Knowledge & Abilities:
- Customer Service oriented with attention to detail and quality.
- Reliable, consistent, proactive and accountable, adaptable to changes.
- Ability to effectively collaborate as part of a cross-functional team yet can also work independently.
- Problem solving skills.
- Must be able to effectively prioritize and plan.
- Strong communication and facilitation skills to develop consensus, clarity, and decision-making.
Experience:
- Experience with business process development and gap analysis, and business process mapping efforts.
- Experience with Veeva Vault Quality QMS is highly preferred.
- 5+ years in a pharmaceutical/biotech or medical device environment required.
- Experience working in a GxP environment(s) is required, including change control, change management, CSV
- Experience working with outsourced Software as a Service (SaaS) Vendors
Thanks & Regards,
Nadeem khan
Senior -Recruitment Executive
469-598-1868 Ext.868
500 N Central Expwy #500G
Plano, TX USA 75074
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