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Summary of Position

The Senior Quality Assurance Engineer is responsible for the Quality oversight for Validation, Engineering and Maintenance at the site. This position requires strong technical and quality skills. The position reports directly to the Senior Manager or Senior Director of Quality Assurance. Knowledge in pharmaceutical quality systems with proficiency in quality oversight of: Validation, Engineering, Maintenance, Manufacturing, QC, Regulatory, CAPA, Deviations, Out of Specification Investigations, and Annual Product Reviews.

Essential Functions

Take a lead role for site/corporate development and maintenance of facility's quality systems and procedures.
* Review and approve Change Control/Process Management Documents involving product or process changes.
* Key personnel for FDA or other regulatory agencies for on-site audits.
* Reviews and approves IOQs, requirement documents, SOPs, validation documents and data integrity assessments.
* Assemble, analyze and report QA system data to ensure regulatory compliance, identify trends and to identify areas of improvement.
* Conduct quality audits and develop and assess subsequent corrective action recommendation(s).
* Developing procedures, statistical evaluations, and remediation of systems.
* Ability to adapt quickly in a fast-paced dynamic environment.
* Ability to communicate with and positively influence broad and diverse populations within and outside the organization.
* Ensure a safe and quality working environment through training, awareness and compliance to safety guidelines and SOP's.
* Ensure the maintenance of the department, premises and equipment.
* Additional areas of responsibility may include developing specifications, standard operating procedures; providing quality system training and actively participating in Quality Review Board meetings.
* Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)

Requirements

Bachelor of Science in Biology, Chemistry, Life Sciences or related field required
* Five or more years of relevant Quality or Validation experience in a finished pharmaceutical manufacturing environment with strong understanding of and exposure to applicable quality systems.
* Experience in supporting on-site inspections for regulatory agencies.
* Significant experience investigating Deviations and other variances.
* Must be thoroughly familiar with applicable regulatory guidelines concerning the establishment, validation, and documentation of test procedures, equipment, processes and facility systems.
* Working knowledge of cGMP guidelines and their application in a controlled aseptic environment
* Must be able to work with other groups to seek understanding and resolve issues, close gaps, and seek compliant outcome.
* Must have experience with statistical tools Proficient in use of Microsoft suite of products. LSNJN-CR_1733244962 To Apply for this Job Click Here