وظيفة رئيس قسم التحقق في شركة جلاكسو سميثكلاين للأدوية
Validation Engineer Section head
Requisition ID: WD186968
Position: Full time
Open date: Oct 29, 2018 1:38 PM
Functional area: Engineering
Location:
Giza, Giza – Egypt
Required degrees: Bachelors
Your Responsibilities:
Job Purpose
Managing computer system validation activities for any CSV system testing related to new and existing systems in site, and improve CSV performance and site capabilities to comply with GSK requirements
Key Accountabilities/Responsibilities:
1.Manage CSV department resources to cover all CSV testing for existing and new systems in site
2.Managing the coordination process of the Computer System Validation activities with both value streams and Engineering departments
3.Asses and Manage systems that have risks associated with the systems that will require testing/replacement more than the scripted schedule and assessing the existing controls and putting leverage points
4.Lead the CSV work activities, planning, and execution associated with new projects and delivery of new systems into the site
5.Responsible to ensure that security requirements for site systems is implemented and in use for both value streams and utilities systems
6.Ensure that all CSV LSOP’s, protocols and CSV master plan are in place, updated and ready for local or external audit
7.Responsible to ensure that any completed CSV documents or CAPA actions are reviewed and ready for being audited
8.Ensure deployment of effective L1 self inspection runs versus L1 plan
9.Attend or delegate Engineering and CSV tiers board on regular basis
10.Responsible to deliver Validation review testing reports for all validated systems as per Validation Review plan
11.Ensure that CSV testing execution plan, CAPA’s, CCR’s and risk actions are adhered to set plan and all related KPI’s are updated and according to plan timeline
12.Responsible to deliver and execute all CSV corrective and preventive actions (CAPA’s) generated from systems testing as per timeline
13.Avail and create full training material to be official for any CSV Engineers
14.Attend all governance meeting related to CSV activities such as quality council, RMCB,…etc., on regular basis
15.Assist and give regular training for CSV role for all stakeholders department to raise CSV capability in the site
16.Training of new CSV Engineers while maintaining the time line through time
management for both plants schedule
17.Creating and updating a new system of interaction and monthly plan adjustments
18.forming Access plans and controlling business continuity plans/ disaster recovery plans for computerized systems (manufacturing and analytical equipment and machines)
19.Formulate templates for the newly introduced documentations
20.presenting new projects and features being presented plus the escalations for the quality councils
21.Following up on interdepartmental interactions
22.Supporting both qualification and calibration procedures
23.Executing the CSV life cycle and produce documentations regarding both control
24.systems and analytical systems-performing GAP analysis vs QMS and guidelines +
forming mitigation plans to breach the gap
Why You?
Basic qualifications:
•Bachelor Degree of Engineering.
•5-7 years experience in pharmaceutical industry
•Knowledge in validation and production activities
•Fluent English is essential ( written, spoken and read)
•computer skills,
•Good communication skills.
•Analytical thinking and problem solving,
•Knowledge of the QMS and its implementation,
•Knowledge of ISO, GLP, EFIS, and GMP requirements
Preferred qualifications:
Why GSK?:
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
Contact information:
You may apply for this position online by selecting the Apply now button.
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