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QA Validation Specialist - GMP Equipment

Company Name:
HireMinds
Expanding mid-size GMP Pharmaceutical company here in Massachusetts looking to add QA Validation Specialists to their growing team! This role will ensure that all new or existing pieces of equipment, utilities, processes, and QC laboratories are adequately validated in accordance with the requirements outlined in the approved site requirements, the approved validation test protocol, and applicable policies and procedures and compliance with company and regulatory requirements e.g. GMP, CFR and local regulations. Responsibilities include but not limited to:

Provides QA oversight and/or review during the validation process for both Manufacturing/Process functions and QC Analytical lab equipment and methods
Supports the Validation Team in evaluating all tests needed to qualify critical equipment, utilities, and processes
Performs compliance reviews of Validation Protocols and Final Reports in support of validation efforts
Develops and revises applicable SOPs and provides compliance oversight and support to other departments upon request
Performs compliance reviews of change control requests and serves on Change Control Board
Performs compliance reviews of all applicable Deviations, Investigations, and CAPAs related to qualification and validation
Reviews project, validation and change control documentation for the site's QMS (Document Management/Compliance Modules) to assure compliance
Reviews and oversees execution FAT, SAT, and Commissioning of Equipment
Reviews and suggests continuous improvements to the Validation Master Plan, current quality system practices, validation protocols and procedures for newly installed equipment, and overall validation strategies
Other duties may include support to the Validation Team in evaluating all tests needed to qualify critical equipment, utilities, and processes

Requirements:
B.S. degree in related science or engineering field and 4+ years of GMP pharma validation experience.

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