Quality Assurance - Validation Senior Specialist
Follow-up and review implementation of all validation activities including: process/product, cleaning and computer system validation, quality risk management activities and change management activities before being presented to validation lead for final revision & approval.
Prepare validation activities plans & issue
protocol that comply with regulatory requirements & company policy.
Witness and follow-up validation run execution,
collect all necessary data and register and assess any anomalies.
Issue validation report, communicate validation
outcome with management and concerned stakeholders and archive reports.
Register, communicate & assess any changes will be conducted
in site prior change execution & track execution of change actions.
Prepare NCR reports, deviation and NCR risk assessment &
review CAPAs relevant to validation activities.
Register & evaluate identified current or potential quality
risks, suggest with key stakeholders proper mitigation actions &
re-evaluate risk after their implementation.
Provide periodical reports to superior with appropriate analysis
regarding all validation updates to ensure effective & accurate updated
Fulfill other related tasks as asked by management and as arising
from the business.
B.Sc. degree in Pharmaceutical Science or in Science.
Years of Experience:
1 April 2021
Application End Date:
14 April 2021