[10409MSCRMCV] Back fill position: Validation Manager/ Validation lead in Rochester, NY

Title: Validation Manager/ Validation lead

Location: Rochester, NY

Duration: 6 months

 

NEED ID proofs or Visa Copies.

 

Job Description:

·         To manage and ensure that the project schedules are adhered to as per the client specifications and deliveries are as per the time and quality standards.

·         Minimum of 7 to 8 years of experience in a regulated environment: pharmaceutical, biotechnology r related industry.

·         Hands on experience in Validation of SAP modules.

·         Good understanding of Supply chain and manufacturing of Pharma and medical devices

·         2 to 3 years of experience (preferred) in leading teams;

·         Good Understanding of FDA (21 CFR Part 210 & 211, 21 CFR Part 11)and European compliance regulations (Eudralex Vol 4) and GAMP guidelines applicable to computer system validation;

·         Authoring/executing Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports as per the compliance requirements.

·         Possess excellent verbal and written communication skills;

·         Position demands an individual who is willing to travel.

·         Mentoring more junior members of the validation team, and for managing medium-sized projects independently as required.                                                                                                                                                                                                                       

·         Responsible for participating in and contributing to team meeting.     

 

Basic Qualifications:

·         Bachelor's degree in computer science, computer engineering, life science, or any other pertinent degree;      

·         Minimum of 2 years professional experience in pharmaceutical computer systems validation OR in computer systems quality assurance (pharmaceutical and/or consulting background).

·         Technical proficiency with the Microsoft Office suite of tools required, especially Microsoft Word and Excel

·         Experience with a Validation of GxP applications

 

 

Raj Laxmi

Resourcing Specialist

Email: laxmik@systelcomputers.com

Ext:223| D: 678-250-9845

 

 

 

 

 

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