Observation of demo trails and report generation,
Preparation of scale up documents for validation
a) Preparation of batch record.
b) Preparation of cleaning records and sampling guidelines,
c) Writing and executing protocols and test cases for validations.
d) Master plans,
e) Validation protocols,
f) Requalification’s,
g) Technical reports,
h) Specific validation procedures
i) Safety and hazard evaluation,
preparation of Process Flow Diagrams, Piping and Instrumentation drawings and assessment of equipment needs, documentation of campaign configurations by implementing small capital projects, when necessary, to modify or purchase equipment needed,
providing scientific/technical expertise for process improvements and innovative approaches to production and validation activities
Coordinating testing and documentation of projects. (Modification, simulation trails, adequacy checks... etc...)
Identifying exceptions, performing effective root cause analyses, and implementing effective corrective actions ,
Preparation of validation final report.
Work with other departments, including Manufacturing Technology, Engineering , QA and Complete all required documentation for proper traceability complying with regulatory requirements
