Validation Analyst

Duties and Responsibilities

•Ensure that lab cleanliness and safety standards are maintained

•Perform visual inspections of finished products

•Perform analytical testing of finished using validated methods at a high RFT

•Performs analytical testing and Micro/PET to USP, EP, BP monographs at a high RFT

•Identify and troubleshoot equipment problems

•Receive and inspect raw materials & Packaging components

•Review data from internal testing & contract laboratories to ensure accuracy and regulatory compliance.

•Participate in out-of-specification and failure investigations and recommend corrective actions.

•Perform Routine calibration of instrumentation to in house SOPs & WRKs

•Revise standard quality control operating procedures & WRKs

•Identify and reports quality events to line manager

•Ability to document all Chemistry, Micro or packaging analysis independently

•Supports delivery of Key QC systems such as stability study management, RM risk assessments,

reference standards management, environmental monitoring reports and trending

•Ability to write technical reports e.g., end of stability reports, reduced testing risk assessment, validation

protocols and reports

•Demonstrates some competencies of QC instrument maintenance or Qualification

•Write or revise standard quality control operating procedures & WRKs

•Identify quality events and potential root cause determination

•Collate and Supply quality control data necessary for regulatory submissions.

•Prepare or review required method transfer documentation including technical transfer protocols or

reports.

•investigates quality events and potential root cause determination

•Ability to Investigate questionable test results (OOS, OOT, Aberrant)

Competencies

•To communicate instantly any problems/queries concluded by the Laboratory to the Quality Control

Supervisor or QC and Stability Manager.

•Respond promptly to requests and concerns.

•Complete business objectives.

•Ensure the cleanliness and tidiness of your individual workstation and to ensure a standard of good

housekeeping in all areas of the Company.

•Provide flexibility if required when requested to work out side of normal working hours.

•Ensure behaviours follow company policies and departmental expectations