Job summary:

Job description:

Job Title: CSV Analyst

Job ID: 2018-8099

Job Location: Ardsley, NY

Job Travel Location(s): TBD

# Positions: 1

Employment Type: C2H

# of Layers: 

Rate :$50/hr

Visa : GC, USC

Job Responsibilities:

Perform validation of computer and automation systems ensuring compliance to required regulatory requirements.

Partner with the Global IT Compliance organization to gain in-depth understanding of guidelines, requirements and general expectations related to Computer Systems Validation and Compliance

Deliver validation activities in compliance with US and EU regulations.

Participate in the design of systems and equipment, if needed, to ensure that they comply with GMP/GCP/GLP requirements.

Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.

Initiate and implement change control activities in accordance with site procedures.

Compile and analyze validation data and make recommendations for improvements.

Participate on cross-functional project teams with the support of Validation activities.

Author relevant validation documentation (e.g. Master Plans, Test Scripts, Templates, etc.), as defined by the Client's IT SDLC methodology.

Execute all relevant validation protocols and test procedures, as defined by the Clients' IT SDLC methodology

Develop validation documentation as required (e.g. specifications, user requirements, plans, protocols, procedures, traceability matrix, error/defect reports, etc. ).

Execute qualification protocols as required.

Prepare reports of executed protocols for review by QA.

Track and resolve exceptions during qualification activities.

Proactively resolve conflicts between compliance requirements and project/business constraints.

Co-ordinate validation activities with IT, Business, QA activities.

Skills and Experience Required:

Required:

5-10+ Years: Computer System Validation

2-4+ Years: BIO/Pharmaceutical industry experience

Experience with equipment controlled by ERP, LIMS, EMS, PMS, and other Quality and Development Laboratory systems.

Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11, Part 820, and GAMP standards are required.

Process Validation – CQA – Calibration, Manufacturing Equipment Software Validation

Must understand Manufacturing Line and Operational Excellence in Production Environment utilizing Software that validates equipment

Solid understanding of Good Manufacturing Practice

Root cause analysis; experience investigating and troubleshooting automation and control systems

Background in Engineering

Ability to work in cross-functional team environments, as well as independently, and to work multiple and competing projects

Strong written and verbal communication skills

Knowledge of MS Office, SharePoint, MS Project, and Visio.

Must be local - Face to Face interviews are required

Desired:

Knowledge/familiarity with U.S. and Global regulatory registration of drug products is preferred.

International, cross culture, and cross functional experience desired

Project management skills

ISO-13485:2016 knowledge and experience

Contact the recruiter working on this position:

The recruiter working on this position is Suhasini Thota(Ravi Team)
His/her contact number is +(1) (703) 3494245
His/her contact email is suhasini@msysinc.com

Our recruiters will be more than happy to help you to get this contract.