Sr Executive – Validation / IT

4 - 6 Years
Saudi Arabia, Saudi Arabia Riyadh

Job Description

Sr Executive for Riyadh (KSA) - Well reputed Pharma company
Experience Required: 4 to 6 year(s)
Location: Riyadh, Saudi Arabia


Preferred to have additional experience in Track and Trace process using Jekson, TraceLink and SAP ATTP
Preferred to be from an EU GMP\ US FDA company
Have good knowledge in IT Infrastructure, Pharmaceuticals Manufacturing process, QMS, SAP, LMS, and QC related SW

Job Description:
1. Prepare and implement Computerized System Validation policy and procedures in accordance with regulatory standards.
2. Participate with the URS team and provide Instruments/machines software requirements.
3. Perform GxP impact assessment and Computerized system categorization assessment for the Production and Quality control instruments, equipment, and define validation approach.
4. Prepare and execute Validation Protocols and procedures for the assigned computer system and software validation projects.
5. Prepare Computerized system inventory and maintain it update to date with the current status. Maintain and control of validation related documents.
6. Prepare and implement IT related policies and procedures (SOP) and ensure compliance.
7. Works with project teams to help implement Internal Systems.
8. Asset IT manager to implement IT Governess process using COBIT and ISO standards
9. Suggests areas for improvement in internal processes along with possible solutions.
10. Securing valuable information within the IT Department. Maintaining confidentiality with regard to the information being processed and stored or accessed.
11. Assists the IT management on preparing the department for any external/internal audits.
12. Relays relevant IT related information to the company in a timely manner. Respond/act on management directions.
13. Responsible to follow the GxP practices, implementation and follow-up of the quality system and its procedures
14. The person nominated by department manager is responsible to carry out the responsibilities of the position in case of absence or whenever the need arise
15. Professional knowledge about theoretical concepts and principles in a specialist field normally associated with a professional or academic qualification or significant experience.
16. Performance or supervision of related activities that is precise as to content and objective and requiring awareness of related activities.
17. Interaction with others requires highly developed skills to motivate, inspire and persuade.
18. Work requires the consideration of future implications beyond the immediate problem and may involve the creation of new approaches and procedures to solve the problem.
19. The level of discretion is governed by established practices, procedures and policies.
20. Outputs are subject to managerial review and jobs typically have a contributory impact on a medium sized organization through the determination of resource utilization in the medium term and through the provision of advisory or facilitative services upon which others take action

Required Candidate profile

Preferred to have additional experience in Track and Trace process using Jekson, TraceLink and SAP ATTP
Preferred to be from an EU GMP\ US FDA company
Have good knowledge in IT Infrastructure, Pharmaceuticals Manufacturing process, QMS, SAP, LMS, and QC related SW

Salary: Not Disclosed by Recruiter

Industry:Pharma / Biotech / Clinical Research

Functional Area:IT Software - QA & Testing

Role Category:QA/Testing/Documentation

Role:Quality Assurance/Quality Control Executive

Keyskills

Desired Candidate Profile

Please refer to the Job description above

Company Profile

Jekson Vision Pvt Ltd

www.tabukpharmaceuticals.com/
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Contact Company:Jekson Vision Pvt Ltd