Computer System Validation Lead@ Remote

Greetings from Excel-EST!!

We are looking for Computer System Validation Lead@ Remote, for the opening with one of our clients.

Job Title: Computer System Validation Lead

Location: Remote

Type: Contract

Qualifications

REQUIRED

We are looking for a CSV lead with GMP experience in creation, review and approval of CSV deliverables for laboratory informatics implementation projects.

Responsibilities

· Improve the effectiveness and efficiency of the existing CSV delivery model through the creation of various templates, stools, training courses, and the periodic collection of KPI metrics;

· Provide thought leadership for GMP Systems by working across different departments to deliver CSV-related programs, innovations, and communications;

· Contribute to the operational and process improvement initiatives related to Quality and Compliance;

· Apply CSV expertise to make a major contribution to a specific business unit or department;

· Interpret and execute company policies and procedures that typically and recommend modifications to operating policies.

· Develop Validation testing strategy in accordance with Gilead’s policy and procedures

· Work closely with other validation team members to ensure system impact is assessed and mitigation strategy is in place for multiple sites

· Partner closely with the business to ensure that CSV methodologies are well understood and applied in a manner that will procedure the most value on LIMS projects

· Learn and become proficient the EDMS (Electronic Data Management System), for

document review and approval and ELMS (Electronic Leaning Management System) for documenting and performing assigned training.

· Prepare, revise and obtain approval of the following documents for GMP laboratories related to the LIS systems:

o Standard Operating Procedures (SOPs)

o Work Instructions (WIs)

o Forms

o User Manuals / User Guides / User References / Quick Reference Guides and Training Material

o Training Plans

o Reference Documents

o Specifications

o Reports

Required Experience / Skills:

· Minimum of 10-12 years of experience working in CSV field and GMP pharmaceutical / biotechnology / medical device environment. Laboratory experience as a chemist or microbiologist, et al is preferred.

· Advanced knowledge and expertise Computer System Validation, FDA& international requirements and Part 11requirements.

· Ability to master technical content through interaction with subject matter experts.

· Effective communication and interpersonal skills.

· Computer Systems Validation (CSV) experience writing validation deliverables per GAMP guidelines is required.

· Understanding of programming and relational database concepts is required.

Required Education:

· BA/BS degree; e.g. biology, chemistry, computer science and/or technology disciplines is preferred.

I would appreciate it if you could reach out on my below mentioned contact coordinates, should the position be of interest to you.

Have a great day ahead!!

Regards,

Alam Rahman

Lead Recruiter

Excel-EST, LLC

Phone: +1-214-550-6407

Email: AlamR@ExcelEST.com

Web: www.excelest.com

17290 Preston Rd, Suite 300-F, Dallas TX, 75252

https://www.linkedin.com/in/alam-rahman-900b23241/

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