09/04/2025 updated
100 % available
Senior Quality Assurance Executive with 12+ Years in Pharmaceutical Validation
Hyderabad, India
Worldwide
M.Pharmacy (Pharmaceutical Analysis)AutoclavesBiopharmaceuticalsCleanroomsGood Manufacturing PracticesEnvironmental MonitoringSterilizationQuality ManagementCooling, Air-conditioning and VentilationValidation ProtocolsProtocol DevelopmentPharmaceutical Production
Pharmaceutical Validation
Extensive experience in qualification and validation of pharmaceutical equipment, utilities and processes for solid orals, sterile injectables and biopharmaceuticals.
Quality Assurance
Expertise in preparation and review of qualification protocols, validation documentation, and ensuring cGMP compliance in pharmaceutical manufacturing.
Green-field Projects
Specialized knowledge in qualification of green-field pharmaceutical projects, including facility design qualification and commissioning.
Protocol Development
Proficiency in preparation of qualification protocols (IQ, OQ, PQ) and validation protocols for pharmaceutical equipment and processes.
Clean Room Technology
Knowledge of clean room validation including CIP/SIP, terminal sterilization, and qualification of controlled environments.
HVAC System Qualification
Experience in qualification of HVAC systems, temperature mapping, and environmental monitoring in pharmaceutical facilities.
Equipment Qualification
Expertise in qualification of pharmaceutical manufacturing equipment including autoclaves, filling machines, and processing equipment.
Extensive experience in qualification and validation of pharmaceutical equipment, utilities and processes for solid orals, sterile injectables and biopharmaceuticals.
Quality Assurance
Expertise in preparation and review of qualification protocols, validation documentation, and ensuring cGMP compliance in pharmaceutical manufacturing.
Green-field Projects
Specialized knowledge in qualification of green-field pharmaceutical projects, including facility design qualification and commissioning.
Protocol Development
Proficiency in preparation of qualification protocols (IQ, OQ, PQ) and validation protocols for pharmaceutical equipment and processes.
Clean Room Technology
Knowledge of clean room validation including CIP/SIP, terminal sterilization, and qualification of controlled environments.
HVAC System Qualification
Experience in qualification of HVAC systems, temperature mapping, and environmental monitoring in pharmaceutical facilities.
Equipment Qualification
Expertise in qualification of pharmaceutical manufacturing equipment including autoclaves, filling machines, and processing equipment.
Experience
Professional experience5 - 10 years
Freelancer since2025
Languages
EnglishFluent
Project history
Preparation and review of validation protocols (IQ, OQ & PQ), execution and compilation of qualification activities for various equipment including Autoclave, Tunnel Sterilizer, and Clean-in-place systems.
Preparation of process performance qualification protocols, review of executed data, preparation of qualification reports, and monitoring of process validation batches.
Preparation and review of qualification documents, execution of C&Q protocols, and verification of system drawings for pharmaceutical equipment.