SDLC Documentation Specialist Required Skill Set:
1. Proven Technical Writing Skills for SDLC Deliverables
2. Thorough knowledge of Good Documentation Practices in a GxP Regulated Environment
3. Thorough knowledge in Good Testing Practices in a GxP Regulated Environment
4. Prior experience writing, reviewing and/or approving SDLC validation deliverables throughout all phases of a system implementation.
5. Computer Systems Validation knowledge.
6. Candidate must strive to interject quality into all tasks and deliverables assigned and must complete a quality review / update against applicable policies & procedures.
7. Excellent communication skills.
a. Must be able to clearly convey documentation requirements to business end users and IT associates.
b. Must be able to handle push back from end users, in a respectful and non-combative manner. Ability to influence others is a key skill.
c. Must freely communicate issues or potential risks to Validation team swiftly and responsibly. Understanding of responsible communication is key.
8. Prior experience performing system's validation in regulated industries (i.e. pharmaceutical / device manufactures).
9. Ability to perform testing in a regulated environment (as required).
10. Working knowledge of Part 11 Requirements.
a. Must be able to demonstrate practical application of Part 11 requirements into system design and associated validation deliverables.
11. Prefer candidates with a working knowledge of Sarbanes Oxley (SOX) Regulations, and prior experience ensuring the validation efforts mitigate potential SOX risks.
12. Prior experience with SAP as an end user, developer, or validation support is preferred.
a. Previous experience validating multiple modules of SAP 4.7 or ECC 6.0 is a strongly desired, but not required.
13. Flexible work style is essential as candidate will be partnering with multiple teams and working on an array of projects at any given time.
a. Must easily transition from one team / task to the next.
14. Candidates with prior experience performing systems audits for compliance to SDLC methodology and regulatory requirements are preferred.
1. Review / Update URS/SRS/SDS requirements.
2. Review / Update IQ / OQ / PQ Test Cases.
3. Execute Testing as needed
4. Create Summary Reports for Testing, Design, System Risk, and Traceability