Quality Compliance and Validation Lead
Hochster Pharmaceutical Industries
Total years of experience :20 years, 8 Months
Manage the pharmaceutical regulatory GxP regulations throughout the manufacturing site, including handling internal and external auditing activities.
Maintain and responsible KPI’s for managing, measuring and improving QMSs performance.
Lead the quality operation team to maintain the manufacturing processes to standard KPIs.
Handle of CAPA, investigating non-conformances and deviations to change control procedures based on a well-developed Quality Risk Management (QRM) system.
Manage the products manufacturing process development to meet the optimized quality standards.
Task owner of the QMSs (ISO standards) implementation, auditing and certifications.
Create quality risk management system adhering international pharmaceutical regulations.
Responsible the implementation of the site Validation Master Plan (VMP) for machine, equipment utilities qualification, process and method validation.
Prepared and updated the required validation master plans (VMP) and schedules.
Responsible for developmental stages of process validation and risk assessment for hazardous products.
Managed manufacturing machine performance qualification plans and reported on over all equipment efficiency (OEE).
Reported on outcome of regulatory inspections and ensure responses are complete and managed.
Lead manufacturing process improvement projects engaging Six Sigma roadmaps for a wide range of drug dosage forms
Ensure that procedures and specifications are appropriate and followed.
Performed deviation investigations for non-conformances to process, methods validation and performance qualification protocols acceptance criteria.
Responsible for periodic GxP internal and external audit compliance, and quality management reviews.
Produced Reports on the GMP compliance in the manufacturing site.
Created qualification and validation master plans, protocols and reports
Responsible for integrating the GMP requirement within the ERP (ORACLE) system.
Created, conducted and following GMP, GSP, GLP and safety training programs.
Led quality risk assessment and control plans throughout the manufacturing site.
Evaluated and ratified technical deviation, CAPA and change control procedures.
Handled continuous improvement projects focusing on product quality and process efficiency.
Responsible for the in-process quality control activities including sampling, testing and reporting.
Created deviations, root cause analysis reports and CAPA plans based on QMS requirements.
Evaluated the product quality during manufacturing process validation stages.
Handled product customer complaints according GMP standards.
Executed training program according to quality management system.
Responsible for microbiological environmental monitoring and aseptic process validation plans.
Created quality operations SOP’s, Annual Product Review (APR).
Carried out the release of product batch on SAP system.
Responsible for clean rooms microbiological control for sterile and non-sterile area.
Responsible for microbiological water analysis, raw material, bulk and finished products.
Handled clean room qualification and aseptic process validation.
Produced validation and routine test method for sterile and non-sterile products.
Performed validation and routine sterility testing and Endo-toxin limit test.
Handled cleaning validation projects in sterile and non-sterile manufacturing sites.
Lead dry and steam sterilization equipment and process validation.
Carry out of specification (OOS) result investigation reports.
Implementation for quality systems ISO 9001/2000 and HACCP standards.
Coordinating internal auditing.
Maintenance of quality records.
Change control.
Establishing training programs.
Total Quality Management