Senior Technical Lead

• Candidates need to have hands-on experience in validating and implementing infrastructure systems associated with Infrastructure related applications.
• Experience in the Pharmaceutical, biotechnology, or medical device industry
• 2+ years’ experience with System Development Lifecyle
• 3+ years’ experience in Computer System Validation (Based on the role selected) Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
• Knowledge of FDA guidance’s and industry standards (i.e., GAMP)
• Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/ Validation Reports Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs. Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
• Strong verbal and written communication skills. Ability to work as a team player, lead a team or accomplish tasks without supervision.
• Ability to work with remote teams and support several changes/projects simultaneously.
• Ability to provide Validation guidance, timely reviews, and escalations to TQ management.

Must be able to support 9:00 am to 3PM for USA Eastern Time ( New York ) time zone., * Candidates need to have hands-on experience in validating and implementing infrastructure systems associated with Infrastructure related applications.

• Experience in the Pharmaceutical, biotechnology, or medical device industry
• 2+ years’ experience with System Development Lifecyle
• 3+ years’ experience in Computer System Validation (Based on the role selected) Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
• Knowledge of FDA guidance’s and industry standards (i.e., GAMP)
• Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/ Validation Reports Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs. Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
• Strong verbal and written communication skills. Ability to work as a team player, lead a team or accomplish tasks without supervision.
• Ability to work with remote teams and support several changes/projects simultaneously.
• Ability to provide Validation guidance, timely reviews, and escalations to TQ management.

Must be able to support 9:00 am to 3PM for USA Eastern Time ( New York ) time zone.

Skill Requirements

Must Have Skill

Computer System Validation (CSV),Life-Sciences (GxP/FDA/CSV/IQ/OQ/PQ)