Validation Section Head At GSK
Job description
Manage and ensure the implementation of validation activities as per mandated requirements and policies.
Maintain the validation status for systems through validation lifecycle management, validation review plans (when applicable) and management monitoring.
Ensure validation/Qualification systems are in an inspection readiness state.
Key Responsibilities:
Support in achieving site/department goals and projects by participating in Site Validation master plan creation and taking the accountability to ensure the right first time implementation of systems/projects.
Process Validation/Qualification:
Create Process validation master plans for different dosage forms.
Overall, understating product lifecycle management, participating in PLM Stage 1 and ensuring prerequisites to Stage 2.
Develop, design and create process validation protocols with the appropriate acceptance sampling plans for statistical decision-making.
Analyze, document, and approve validation summary reports to ensure the implementation of stage 2
Cleaning Validation:
Create and develop cleaning validation master plans, risk-based rationales and cleaning risk assessments to define the cleaning validation program.
Create and approve cleaning validation protocols and reports.
Holding time studies:
Create Holding time validation master plans, rationales, protocols and reports as per WHO Technical Series 992,2015
Maintain the validation status for systems through effective validation review and maintenance plans.
Ensure systems inspection readiness by leading and Participating in process confirmation Gemba and management monitoring runs.
Ensure compliance with data integrity requirements and be responsible for DI implementation within validation systems to ensure that the requirements are in place, in use, and effective.
When needed, support equipment process/utility qualification by preparing required validation life cycle documents according to validation lifecycle, computer system validation and Data integrity requirements.
When needed, support ITMS Qualification with the above sites, approve and witness ITMS validation activities. And conduct related ITMS validation review plans.
Basic Qualifications
We are looking for professionals with these required skills to achieve our goals:
Bachelor’s degree in Pharmaceutical Science
Knowledge of product design, PLM and pharma dosage forms
Knowledge of SAP, Statistics (or any alternative statistical tool)
From 3 – 5 years of experience in Validation/Production and/or Operational Quality
To gain knowledge of process measurements and validation readiness
Good Command of English language
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Teamwork
Decision Quality
Situational Adaptability
Production Knowledge
Analytical thinking
PLM knowledge
Report writing
Good Strategic planning
Good Negotiation skills
Good Communication and organization skills
Courage and accountability
Job Posting End Date:
14.05.2024