Validation Specialist

1.        Provides, implements and administers validation functions to ensure validation compliance with cGMP requirements.

 

 

2.        To remain knowledgeable of the cGMP regulations.

 

 

3.        To implement validation protocols with the knowledge and understanding of engineering and documentation requirements of the validation activities.

 

 

4.        Owns updating and adhering to the Plant's Master Validation Plan

 

 

5.        Serves in an advisory capacity to the completion of the items of the Master Validation Plan

 

 

6.        Owns updating and getting commitment on the validation protocols for deionized water, HVAC systems, compressed air, steam and room validations.

 

 

7.        Maintains the record keeping for the completion of the qualification by operational area for, operational, performance, and equipment qualifications.

 

 

8.        Responsible for ensuring that procedures are upgraded with system changes and Change Control is monitored for impact to Validation.

 

 

9.        Has ownership for ensuring the technical rationale for limit assignment is in-line with the current customer trends for cleaning and sanitization validations.

 

 

10.     Ensures that the Plant is on-target for completion of appropriate validations and tracks goal completion.

 

 

11.     Reports status against the listing of method validations

 

 

12.     Assists the Information Services Department in the arena of computer master validation planning and adherence to that plan.

 

 

13.     Facilitates customer protocols for product/packaging validation, by communicating the needs of the validation and the resources to be allocated, and by gaining commitment from all parties.

 

 

14.     Acting in an advisory role as required.

 

 

15.     Any other reasonable duty as assigned by the supervisor.