1. Conduct validation studies in accordance with current industry standards and guidelines for the qualification and validation of computerized systems.
2. Develop and execute qualification and validation protocols for computerized systems.
3. Assist in the establishment and maintenance of procedures, tools and methodologies to cover all GxP computer systems lifecycle phases
4. Manage or assist with audits of current and prospective suppliers of software applications and services. Maintain a working knowledge of applicable regulations and standards associated with computer systems validation in order to maintain a state of compliance while providing innovative solutions to meet changing business needs
5. Follow the plan of qualification to be completed during each calendar year and execute approved protocols to gather data.
6. Analyze the resulting data and develop the final validation report and investigate and document all validation related deviations and determine assignable causes
7. Participate in regulatory and internal inspections/audits including providing written responses as applicable for area of responsibility.
8. Adhere to departmental corporate safety policies
1. Bachelor of Science degree in pharmaceutical, Engineering, Biology, Chemistry, Biochemistry or closely related scientific/technical discipline is required.
2. Minimum of 2 years direct validation experience in computer system validation in a pharmaceutical, biologics, medical device or SFDA related manufacturing facility is required.
3. Requires an in depth understanding of validation, pharmaceutical manufacturing and laboratory processes /equipment.
4. Comprehensive knowledge and understanding of cGMPs, SFDA regulations, and industry guidelines.
5. Must have strong technical writing skills.
6. Ability to work independently with minimum supervision.
7. Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
8. Must be proactive, results oriented, and have strong attention to detail.
9. Self-starter with strong work ethic and the ability to exercise good judgment.
10. Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
11. Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.
12. Excellent verbal and written communication skills in the English language.
13. Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
14. Must be flexible with working hours / shifts in order to accommodate the plant operation.
- Job Location
- Mecca, Saudi Arabia
- Company Industry
- Manufacturing and Production; Pharmaceutical
- Company Type
- Employer (Private Sector)
- Job Role
- Purchasing and Procurement
- Employment Type
- Full Time Employee
- Monthly Salary Range
- Number of Vacancies
- Job Ref.
- Career Level
- Mid Career
- Years of Experience
- Min: 2
- Residence Location
- Saudi Arabia
- Bachelor’s degree / higher diploma