Posted in Information Technology 30+ days ago.
Type: Full-Time
Location: San Antonio, Texas
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. |
BCFS
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Innovative Network of Knowledge (INK)
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Compass Connections
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Prudential Ins Co of America
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Prudential Ins Co of America
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Vactor Manufacturing
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