QA Validation Analyst/Engineer II
Weil GroupBarceloneta, Puerto Rico
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Overview
Schedule
Full-time
Career level
Senior-level
Remote
On-site
Job Description
The QA Validation Analyst/Engineer is responsible for planning and overall approval of validation tasks. Responsibilities may also include executing validation activities. Under the direction of the Validation Section Manager, this individual will participate in the implementation of the Validation quality program at the plant under minimal supervision. Level of responsibility and performance is commensurate with grade level. The Validation Engineer responsibilities may include: the review of commissioning and validation documentation completed by others, leading, authoring or reviewing investigations and implementation of preventive and corrective action, review and authoring of plant standard operating procedures, review and approval of critical planned maintenance routines, set-up of laboratory samples for qualification, participation in the establishment of plant quality systems, supporting regulatory and third party audits. Responsibilities: List up to 10 main responsibilities for the job. Include information about the accountability and scope.Responsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements. Ensures that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility. Executes tasks as required to implement the Validation Master Plan and maintain in a validated state the equipment, utilities, facilities, automated process controllers, information systems, cleaning processes, manufacturing processes, laboratory instruments and analytical methods to demonstrate that product will perform consistently as intended.•Ensures investigations of validation failures are completed thoroughly and documented accurately and are included in the plant CAPA system where required by policy.•Participates with plant and external engineering resources on new installations/systems to ensure that factory/site/commissioning documentation is in accordance with cGMP and supports validation.•May supervise contract validation resources in the timely completion of activities in his/her area of responsibility..*Weil Group is proud to be an Equal Employment Opportunity Employer.*
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FAQs About QA Validation Analyst/Engineer II Jobs at Weil Group
What is the work location for this position at Weil Group?
This job at Weil Group is located in Barceloneta, Puerto Rico, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Weil Group?
Employer has not shared pay details for this role.
What employment applies to this position at Weil Group?
Weil Group lists this role as a Full-time position.
What experience level is required for this role at Weil Group?
Weil Group is looking for a candidate with "Senior-level" experience level.
What is the process to apply for this position at Weil Group?
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