CSA Validation SME

Client Name: StevenDouglas
End Client Name: Maybelline

Job Title: CSA Validation SME (Computer Software Assurance GxP/GAMP 5)
Location: Long Island City NY (Hybrid 3 days onsite)
Work Type: Hybrid
Job Type: Contract (1 Year)
Rate: $60 65/hr W2 (Client Flexible a bit)

Note:
***PLEASE Only send me candidates in the NY/NJ area Open to hybrid.
***Needed A senior CSA (Computer Software Assurance) SME with experience GAMP 5 GxP and 21 CFR Part 11 standards. Candidates need to have previous experience in a GxP industry or a life sciences industry is required as well as Technical competency in FDA regulations. They must draft and execute of GxP Assessment Risk Assessment (RA) Validation Plan (VP) Test Plan (TP) and Validation Summary Report (VSR) as necessary . Candidates must have expertise in generating reviewing and addressing CAPAs as well as experience with Data Integrity and ALCOA is a plus
**** A CSA Validation SME (Computer Software Assurance Subject Matter Expert) with expertise in GxP and GAMP 5 plays a critical role in ensuring that computerized systems used in regulated environments (like pharmaceuticals biotech and medical devices) are compliant validated and fit for intended use - without over-documenting non-risk areas.

***Candidates must have Long Projects/Good Tenure Excellent communication skills and a State issued ID (Not Bills) showing they are Local.

***Candidates must be LOCAL to the NEW YORK or NEW JERSEY area and COMMUTE into the office THREE TIMES A WEEK. NO RELOCATION CONSIDERED.

Please make sure that each submittal includes:

1. Drivers license or State ID

2. Link to the candidates LinkedIn account.

3. Below submittal Format

*** Candidate Must Haves on a resume and for submittal:

1. How many years working with: CSA Validation SME

2. How many years working with: GAMP 5

3. How many years working with: Draft and execute of GxP Assessment Risk Assessment (RA) Validation Plan (VP) Test Plan (TP) and Validation Summary Report (VSR)

4. How many years working with: 21 CFR Part 11 standards

5. How many years working with: Generating reviewing and addressing CAPAs

*** Please provide all the below Submittal Format details with each submittal. It is required for the client Management system.

Full Name:

Rate:

Location:

Availability to Interview: One Days notice

Availability to Start:

Email Address:

Phone Number:

Visa Status:

Education - College/Year of graduation:

Link to LinkedIn

Certifications (Please list)

Job Description:

The CSA Validation SME is a key stakeholder in the CSA Center of Excellence (COE). The primary function of this role is to ensure the integrity of CSA projects with an eye to assessing risk and ensuring integrity. Their responsibilities serve as a key conduit between the COE leadership and the protocol author(s) and tester(s). The CSA Validation SME will ensure validation projects meet regulatory and data integrity requirements and they will confirm validation projects meet R&D/GSC/IT policies.

Responsibilities:
Provide insight and expertise on validation project risk and complexity
Maintain validation best practices
Gather project information from system owner(s)
Collaborate with the Business Analyst on a frequent basis
Maintain compliance with Good Documentation Practices (GDP)
Aid in writing and reviewing of reports summarizing system CSA validation execution
Collect feedback from System Owner(s) on deliverables
Draft and execute of GxP Assessment Risk Assessment (RA) Validation Plan (VP) Test Plan (TP) and Validation Summary Report (VSR) as necessary
Draft review and execute other validation documents when necessary

Qualifications:
Bachelors Degree in Computer Science Information Technology Chemical Engineering Biomedical Engineering or related degree
7-10 years of successful progressive experience with Computer System Validation and Computer Software Assurance
Aptitude in GAMP 5 and 21 CFR Part 11 standards
Previous experience in a GxP industry or a life sciences industry is required
Technical competency in FDA regulations
Expertise in generating reviewing and addressing CAPAs
Strong written and verbal communication skills
Strong ability to collaborate with the team
Ability to work self-directed in the timely completion of project deliverables
Practical experience with Data Integrity and ALCOA is a plus
Demonstrated Competencies:
Technical Competency Develop an understanding of business requirements and work to translate the business requirements to the necessary CSV documents and supporting materials
Time Management Able to follow strict deadlines prioritize tasks and work well under pressure
Analytical Skills Identifies researches and demonstrates logical reasoning to communicate critical information
Agility Meets objectives by responding to competing and changing priorities and multiple tasks under inflexible timelines
Strong written and verbal communication skills
Strong ability to communicate with other COE team members
Strong analytical and problem-solving abilities
Understands the purpose of CSA is passionate about customer safety data integrity and product quality
Adept at solution development and project scoping
Effectively collaborate with peers cross-functional teams and departments
Strong technical background is preferred