Validation Contractor Job

Validation Contractor is needed to perform the following duties:

· Responsible for all aspects of validation processes like- documenting commissioning activities, establishing the process and developing and performing qualification studies to provide a high degree of assurance that equipment and processes will consistently produce a drug product meeting its pre-determined specifications along with quality attributes.

· Support in developing Validation Master

· Plan for:

o Execution of GMP Lab systems/Instrument/

o Equipmentof Bio-pharmaceutical Product

o Development and Supply (BPDS) for,

o Cell Banking Manufacturing and Testing

o (CBMT), Microbiology, Systems and Analytical

o Services-Pilot Plant Support (MSAS - PPS).

· Development/Execution qualification (Commissioning/IOQ/IQ/OQ/PQ), Standard operating

procedures (SOP), and specifications for Lab systems/Instrument/Equipment.

· Performed temperature mapping using the KAYE (2000) and Data loggers. And Validate control temperature units like controlled freezers, refrigerator, Autoclaves, Serialization equipment – vial filling machine.

· Analyze and Interpret Validation test data to determine whether systems of process have met validation criteria or to identify root cause of deviations.

· Documentation include, but not limited to: Life cycle documents created and manage Risk Assessments, Validation Plans, Design Specifications, User Requirements, Function- al Requirements, IOQ, IQ/OQ/PQ Protocols, Requirements Traceability

Matrices, Summary Reports, change control, CAPA, Exceptional condition and risk assessments.

· Development including Create, review and modify of Standard operating procedures (SOPs), Maintenance Calibration Procedures, and other Instrument/ equipment support documentation.

· Developing and executing validation protocols maintaining Data integrity and ALCOA principles are essential to for a complaint paper and/or electronic data management life cycle system, complying with GDPs, complying with GMPs, and driving data integrity initiatives.

· Original data is the paper or electronic medium in which the data point is initially recorded including protocol, database, or software application. Understanding where the original data is generated to ensure content and meaning are preserved.

Bachelor's Degree is required in Pharmacy or Pharmaceutical Sciences or Biology.

Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave