QA Validation Analyst/Engineer II

Weil Group•Barceloneta, PR

1d•Onsite

About The Position

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.

Requirements

Minimal supervision required.
Must be able to author and review investigations.
Must be able to author and review plant standard operating procedures.
Must be able to review and approve critical planned maintenance routines.
Must be able to set-up laboratory samples for qualification.
Must be able to participate in the establishment of plant quality systems.
Must be able to support regulatory and third party audits.
Must be able to participate in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements.
Must ensure that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.
Must be able to execute 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.
Must ensure investigations of validation failures are completed thoroughly and documented accurately and are included in the plant CAPA system where required by policy.
Must be able to participate 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.

Nice To Haves

Experience with cGMP.

Responsibilities

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.
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.