Support with training, expertise area all team members as needed.
Support with training for validation process for every new employee orientation outline.
Support with new employee’s review work till deemed trained.
Ensure complete understanding and compliance to Almac CT SDLC.
Write precise as well as thorough Validation Documents included not restricted to Validation Reports, Validation Plans, Master Document Lists and Quality Gates.
Ensure to process Client System subsequent development in real time as delivered for Validation.
Present issues to all Senior Validation Analyst or GL.
Ensure to identify quality risks and report project team plus QA staff for evaluation as well as resolution.
Provide feedback in continuing validation process improvement.
Participate in customer as well as FDA system audits as needed.
Support validation team responses for audit findings as well as corrective actions.
Comply with all company policies as well as procedures.
Recommend changes to Working Instructions (WIs) and Standard Operation Procedures (SOPs).
Write precise and complete records to assist clinical data systems validation.
Analyze results from allotted test programs to assure accurate, complete documents and results.