Validation Section Head At GSK
Job description
Site Name: Egypt – Giza – Giza
Are you looking for an opportunity to manage projects, identify areas of improvement and support safety working practices? If so, this is the job for you.
As a Validation Section Head, you will manage and ensure the implementation of Pharmaceutical Validation activities in regards to Process validation, Cleaning validation, Bulk holding time validation , Air system & Water System qualification and media fill runs. You will maintain the validation status for systems through validation lifecycle management, validation review plans (if applicable) and self inspections.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Create and maintain an up to date Site validation master plan
1- Pharmaceutical Validation
a. Cleaning Validation
Create a Cleaning Validation Master Plan or an equivalent document to define the cleaning program
Create a Cleaning Risk Assessment for each machine and Determine the controls to mitigate any identified risk(s) and the need to dedicate facilities or equipment
Document the justification and rationale for the cleaning approach
Document and approve a protocol prior to the start of each cleaning validation or
verification exercise.
Document and approve cleaning validation report and oversight the cleaning process and ensure proper In Place and In Use aligned with the validation study
b. Process Validation & Bulk Holding Time
Create a Process Validation Master Plan (NPI, or an equivalent document to define the manufacturing process elements
Participate in Technical Risk Assessments (TRA’s) and relevant production trials as a support to technical team
Participate in creation and maintenance of Product Control Strategy
Participate in the process of CPV and ensure process robustness
Document and approve a protocol prior to the start of each PQ study or verification exercise.
Document an approve Process validation report and oversight the process and ensure proper In Place and In aligned with the validation study
Create BHT protocols for finished products and/ or dispensed raw materials as per policies and WHO technical requirements.
c. Media Fill
Initial Process/Line Aseptic filling Validation.
Generate the Media fill validation protocols and Report.
Ensure that environmental systems and supporting equipment (e.g. autoclaves, container/stopper washers, and depyrogenation ovens/tunnels) have been appropriately validated.
Conduct validation runs.
Ensure that media fill process is conducted as per issued protocol
Accumulate, compile, and evaluate all test results.
Prepare the validation report, attach the completed media fill filling log sheet to it and circulate for approval.
Ensure that all environmental systems and supporting equipment remain in compliance through change control, calibration, and preventative maintenance programs.
Assist Operational Quality in investigation reports for media fill when a positive result is obtained.
Lead the communication with above site when needed.
To record video tape for the whole media fill run and to archive all video records.
Submit agreed CAPAs to Compliance department to be uploaded on Carisma3 after conducting meeting of “Learning and Actions” with all concerned departments.
d. Air & Water System Qualification
Create air & water system Qualification protocol
To ensure performance of environmental control validation testing defined in this protocol.
To review validation engineering testing results, viable and non-viable counts results.
To prepare the final report and circulate for approval.
e. Ensure that GMP principles are applied to guarantee quality of supplied products when it comes to validation activities
f. Perform self inspection audits for validation department.
g. Participate in the gap analysis on relevant QMS policies, identify gaps between in-place and in-use.
h. Review and trend analysis for Environmental results obtained and interpretation of results.
i. Support in implementation of aseptic Media Fill Policies
j. Support in sterile capability improvement program.
k. Participate in sterile related control and project involvements.
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelors of Pharmaceutical Sciences
Minimum of 5 years of experience in quality department
Knowledge of product design , validation and sterile filling operation requirements.
Good planning and coordination, problem solving and time management skills.
Strong Analytical Skills & Team Work
Good interpersonal and communications skills.
Ability to work under stress and to manage conflicting priorities.
Production Knowledge & Experience in sterile operations is a plus.
Excellent command of English language