Skills / Knowledge Required:
1. Fundamental knowledge about computer system validation activities (include but are not limited to).
Validation Plan (VP)
Functional Requirement Specification (FRS)
Configuration Specification (CS)
Risk Management Report (RMR)
System Architecture Plan (SAP)
Requirement Traceability Matrix (RTM)
IQ Protocol & Report (Validation Environment)
OQ (Validation Environment)
IQ Protocol & Report (Production Environment)
PQ (Production Environment)
Validation Summary Report (VSR)
2. Process analysis related to activities.
3. Different regulatory knowledge (CSV).
4.
Remain update on most recent regulations (GAMP, 21 CFR part 11, EU annex 11, GxP and other aspects of the regulatory environment for pharmaceuticals).
5. Prepare and carry out software validation tasks, documents, activities, and deliverables for each GxP category system. Closely collaborate with the validation team and quality assurance to guarantee that GxP category systems are appropriately validated and finished within the allotted time frame.
6. Prepare, review software related documents (SOPs, Work Instructions, Manuals, URS, Validation deliverables, etc.) according to the organization SOPs and/or applicable regulatory requirements.
7. Provide sponsor/auditor/regulatory queries related solutions to software process in consultation with Quality Assurance, System Owner and/or Head of Department.
8. Good documentation expertise.
9. Excellent computer skills and experience with MS Office.
10. Excel communication skills and maintain relationships with clients.
11. Ability to work with minimal supervision.
12. Participates in on-going educational activities to enhance own knowledge level as well as that of other team members.
13. Ability to maintain confidentiality.
