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CSV Document Specialist at Cognizant

Posted in Information Technology 30+ days ago.

Type: Full-Time
Location: San Antonio, Texas





Job Description:

Knowledge and strong understanding of Regulatory environments

• Hands on experience in IT processes in pharmaceutical manufacturing

• Sound understanding of 21CFR part 11 guidelines and GMP processes

• Hands on experience in creating/reviewing compliance lifecycle deliverables

• Good understanding of compliance documents across SDLC. Plan and execute validation activities independently, drive the team to perform test management activities in an automated environment

• For Category 3, 4 & 5 systems, each system validation effort includes creation, review and execution of following deliverables:

   1. TW CCR/CAPA initiation and close out

   2. Initial Risk Assessment (GxP Applicability & GAMP categorization)

   3. Security Controls Checklist

   4. Validation Plan (including System Test Plan)

   5. User Requirements Specifications/Critical Process Parameters

   6. Functional/Configuration Specifications

   7. Functional Risk Analysis

   8. Design Specifications (In case Category 5 systems only)

   9. IQ Protocol & Testing

  10.  OQ Protocol & Testing

  11. PQ Protocol & Testing (as applicable)

  12. Requirements Traceability Matrix

  13. Validation Report

  14. System specific Usage, Administration and other relevant SOPs

  15. Training Records and applicable release certificate

Technical Skills




















SNo Primary Skill Proficiency Level * Rqrd./Dsrd.
1 TestLog PL1 Required
2 TestLink PL1 Required

 

* Proficiency Legends






















Proficiency Level Generic Reference
PL1 The associate has basic awareness and comprehension of the skill and is in the process of acquiring this skill through various channels.
PL2 The associate possesses working knowledge of the skill, and can actively and independently apply this skill in engagements and projects.
PL3 The associate has comprehensive, in-depth and specialized knowledge of the skill. She / he has extensively demonstrated successful application of the skill in engagements or projects.
PL4 The associate can function as a subject matter expert for this skill. The associate is capable of analyzing, evaluating and synthesizing solutions using the skill.





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