· Develop and execute validation and equipment qualification protocols to meet regulatory requirements.
· Assess and develop any amendments to the qualifications to deliver fully validated equipment into production within agreed timelines.
· Provide guidance to sites with respect to validation/process deviations and change control as it pertains to systems and test equipment in production.
· Support the validation program and procedural changes that enhance safety, compliance, and overall operational efficiency.
· Support the site’s adherence to the Validation Master Plan.
· Continuously evaluate and identify opportunities for improvement in existing validation programs and procedures.
· Participate in device risk management activities including DFMEA and PFMEA.
· Provide direct technical support on production issues (e.g. part & assembled product quality dispositions, interim containment actions, root cause analysis, resolution planning, validation, & implementation) under NCMR or CAPA.
· Able to develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries.
· Approve validated computer system related change requests.
· Assist in planning, implementing, and documenting user acceptance testing.
Qualification:
This position requires a minimum of Bachelor’s degree in Mechanical Engineering, or closely related field.
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