وظائف شركة جلاكسو سميثكلاين العالمية للادوية GlaxoSmithKline
Validation Engineer
Key Responsibilities:
1- Executing
the Validation Lifecycle for all new and existing GxP systems according to QMS
Determine the impact of the equipment/system on GMP processes through Compliance
Determination
Create and execute validation lifecycle documentation such as (MBP, PRA, CD, URS,
DQ, IQ, OQ, PQ, VSR) as per CSQMS, AEQMS, ITQMS depending on the type of system
Verify the Validation of excel sheets & Validate excel sheets (If necessary)
Perform Periodic Validation Review to maintain and review the validated status
of the systems
Decommissioning of GxP systems and Excel Sheets
2- Acting as
the CSV Lead for Giza Site responsible for:
ATR & Back up Process Owner
Admin user for all lab equipment
Extract audit trail and review with lab/production teams the content and ensure
the gaps are closed (Trackers)
Back up the lab/production equipment software and data
Review the DI assessment after completion by system owner and mitigate the gaps
Record ATR and Back up KPIs and report to DI champion
Raise capability of system owners for effective review of audit trail
Review ATFA and ensure that is reflected in ATR tracker
Review access maps for lab/production equipment
System owner for password Manager Software
3- Responsible
for planning and prioritizing the validation activities through the Validation
Master Plan
Maintain and review Site System register to ensure all mandatory fields are
entered and the systems are accurately recorded.
Reflect the outcome of (SSL) site system list into (VMP) validation master plan
4- Participate/coordinate the execution of validation testing with other departments and suppliers
5- Confirming
DI requirements are met in the design of new and existing system against ITMS ,
QMS &SOPs
Management of data backups system passwords
Managements of users and administrative functions for the different systems
6- Responsible
for the continuous improvement and standardization of the validation
activities/documentation
Maintaining a robust documentation and archival system
Maintain an inspection ready status ahead of any internal and external audits
for validation activities
7- Supporting
the validation capability of the site
Delivering of periodic validation training for all site staff
Basic Qualifications:
Bachelor’s
Degree in Engineering.
1-4 years’ experience
Good command of English language.
Good communication skills
Good computer skills
Accountability
Teamwork
Flexibility
Eager to learn
Analytical thinking
