CSV Validation Engineer

CSV Validation Engineer

HTC Global Services (MSC) Sdn Bhd
4-14 years
Not Specified

Job Description

We have an immediate opportunity in the below positions.
Position - CSV Validation Engineer
Responsibilities:
• Preparation of Validation Plan, Commissioning Plan, and project procedures
• Preparation and review of FAT, Commissioning and SAT protocols
• Preparation and review of Qualification protocols (DQ, IQ, OQ and PQ)
• Evaluates data from executed validation protocols
• Generates or approves Validation Risk Assessment documents in relation to executed validation activities
• Assesses and closes deviations related to closure of validation activities
• Actively participates in relevant change control activities and risk evaluation systems as they pertain to validation
Requirements
• Degree qualification in Sciences or Engineering field
• Knowledge of GMP facilities and cGMP requirements
• Minimum of 1 year of validation experience in pharmaceutical, biopharmaceutical or medical device industry
Interested candidates can apply to [Confidential Information]

HTC Global Services

Established in 1990, HTC Global Services is an Inc. 500 Hall of Fame company and one of the fastest growing Asian American companies in the US with headquarters in Troy, Michigan. A global provider of IT Solutions and Business Process Outsourcing services, HTCs client base spans several Global 2000 organizations. HTC is committed to providing solutions that translate into tangible business outcomes for our customers. HTC manages IT environments, IT applications, and business processes of customers, focusing on providing transformational benefits.

Mission:

We are a global IT solutions provider adding value to our clients and people through emerging technologies. We are dedicated to the success of our clients, employees, business partners, suppliers, community, and stakeholders.

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