Senior Executive, QA Validation

Amneal Pharmaceuticals; Ahmedabad District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Amneal Pharmaceuticals in Ahmedabad is seeking an experienced professional for Qualification/Validation in sterile injectable manufacturing. You will lead end-to-end validation lifecycle including URS, DQ, FAT/SAT, IQ/OQ/PQ and related documentation, ensuring QA standards.

Must have MSc/ BPharm/ MPharm with 7-9 years of hands-on experience in injectable validation, and coordinate with Manufacturing, Engineering and QC to drive timely qualification activities.

Qualifications

• M.Sc./ B.Pharm/ M.Pharm with minimum 7-9 years of relevant experience.
• Hands-on experience in Qualification/Validation function within an injectable pharmaceutical manufacturing environment.

Responsibilities

• To prepare and review URS, DQ, QRM, FAT, SAT, and vendor/supplier's documents related to qualification.
• To execute Qualification / Re-Qualification and Validation activities of Equipment / System / Facility and Plant utilities (HVAC, Autoclave, Isolator, Filling machine, Washing machine, Depyrogenation tunnel, UAFs, Packaging equipment, Water system, Pure steam generation and distribution, Nitrogen/compressed air distribution).
• To perform qualification activities like air flow visualization study, Temperature mapping of Rooms/Chambers, Packaging validation, Transport validation.
• To coordinate with manufacturing, Engineering, Material Management, QC for timely completion of qualification/validation activities.
• To prepare and review Validation/Qualification protocols and reports (IOQ, PQ, RQ, CQ, other qualification documents).
• To prepare and review process validation, cleaning validation, media fill and hold time study protocols and reports.
• To prepare and review SOPs of Validation and Quality Assurance Department.
• To prepare and update Annual Validation Planner.
• To prepare and execute project validation master plan for commissioning and qualification of new/modified facility.
• To assess Change Control, Deviation, CAPA and participate in investigations triggered through deviation, OOS, OOT or other failures.
• To involve in QMS related activities i.e initiation and review of QMS elements.
• To prepare, review and execute risk assessment activity related to equipment/process/facility/system.
• To conduct sampling activities as per protocols (Hold time, Process validation and cleaning validation).
• Establish, monitor and maintain Validation function for audit readiness.
• To prepare VMP and SMF.
• To implement contamination control strategy at site.
• Complete Validation Lifecycle: URS, DQ, FAT, SAT, Commissioning, IQ, OQ, PQ.
• End-to-end validation lifecycle (URS, DQ, FAT, SAT, Commissioning, IQ, OQ, PQ).
• Qualification of equipment, utilities, and facilities in sterile injectable manufacturing environments.
• Process validation and cleaning validation including protocol and report preparation.
• Thermal validation systems and temperature mapping studies.
• Media fill validation principles and execution.
• Basic risk assessment techniques (FMEA approach).
• Validation documentation management and report compilation.
• Use of validation management software and electronic documentation systems.
• Coordination and management of end-to-end qualification/validation activities.

Skills

Qualification/Validation

Injectable manufacturing

Education

M.Sc./ B.Pharm/ M.Pharm

7-9 years relevant experience

Job description

• To prepare and review of URS, DQ, QRM, FAT, SAT, and vendor/ supplier’s documents related to qualification.
• To execute Qualification / Re-Qualification and Validation activities of Equipment / System / Facility and Plant utilities (HVAC system, Autoclave, Isolator, Filling machine, Washing machine, Depyrogenation tunnel, UAFs, Packaging equipment, Water system, Pure steam generation and distribution system, Nitrogen/compressed air distribution system etc.).
• To perform qualification activities like air flow visualization study, Temperature mapping of Rooms/Chambers, Packaging validation, Transport validation etc.
• To co-ordinate with manufacturing, Engineering, Material Management, QC personnel and other users for respective Qualification / Validation / Re-qualification activities for timely completion of activities.
• To prepare and review Validation/ Qualification protocols and reports (IOQ, PQ, RQ, CQ, other miscellaneous qualification documents etc).
• To prepare and review process validation, cleaning validation, media fill and hold time study protocols and reports.
• To prepare and review of SOPs of Validation and Quality Assurance Department.
• To prepare and update Annual Validation Planner.
• To prepare and execute project validation master plan for commissioning and qualification of new/modified facility.
• To assess Change Control, Deviation, CAPA etc. and participate in investigation triggered through deviation, OOS, OOT or other failures.
• To involved in QMS related activities i.e initiation and review of QMS elements.
• To prepare, review and execute risk assessment activity related to equipment/ process/ facility/ system.
• To conduct sampling activities as per the protocols (Hold time, Process validation and cleaning validation etc.).
• Establish, monitor and maintain Validation function for audit readiness.
• To prepare VMP and SMF.
• To implement contamination control strategy at site.
• Complete Validation Lifecycle: URS, DQ, FAT, SAT, Commissioning, IQ, OQ, PQ
• End-to-end validation lifecycle (URS, DQ, FAT, SAT, Commissioning, IQ, OQ, PQ)
• Qualification of equipment, utilities, and facilities in sterile injectable manufacturing environments
• Process validation and cleaning validation including protocol and report preparation
• Thermal validation systems and temperature mapping studies
• Media fill validation principles and execution
• Basic risk assessment techniques (FMEA approach)
• Validation documentation management and report compilation
• Use of validation management software and electronic documentation systems
• Coordination and management of end-to-end qualification/validation activities

Key Responsibilities

JOB DESCRIPTION

• To prepare and review of URS, DQ, QRM, FAT, SAT, and vendor/ supplier’s documents related to qualification.
• To execute Qualification / Re-Qualification and Validation activities of Equipment / System / Facility and Plant utilities (HVAC system, Autoclave, Isolator, Filling machine, Washing machine, Depyrogenation tunnel, UAFs, Packaging equipment, Water system, Pure steam generation and distribution system, Nitrogen/compressed air distribution system etc.).
• To perform qualification activities like air flow visualization study, Temperature mapping of Rooms/Chambers, Packaging validation, Transport validation etc.
• To co-ordinate with manufacturing, Engineering, Material Management, QC personnel and other users for respective Qualification / Validation / Re-qualification activities for timely completion of activities.
• To prepare and review Validation/ Qualification protocols and reports (IOQ, PQ, RQ, CQ, other miscellaneous qualification documents etc).
• To prepare and review process validation, cleaning validation, media fill and hold time study protocols and reports.
• To prepare and review of SOPs of Validation and Quality Assurance Department.
• To prepare and update Annual Validation Planner.
• To prepare and execute project validation master plan for commissioning and qualification of new/modified facility.
• To assess Change Control, Deviation, CAPA etc. and participate in investigation triggered through deviation, OOS, OOT or other failures.
• To involved in QMS related activities i.e initiation and review of QMS elements.
• To prepare, review and execute risk assessment activity related to equipment/ process/ facility/ system.
• To conduct sampling activities as per the protocols (Hold time, Process validation and cleaning validation etc.).
• Establish, monitor and maintain Validation function for audit readiness.
• To prepare VMP and SMF.
• To implement contamination control strategy at site.
• Complete Validation Lifecycle: URS, DQ, FAT, SAT, Commissioning, IQ, OQ, PQ
• End-to-end validation lifecycle (URS, DQ, FAT, SAT, Commissioning, IQ, OQ, PQ)
• Qualification of equipment, utilities, and facilities in sterile injectable manufacturing environments
• Process validation and cleaning validation including protocol and report preparation
• Thermal validation systems and temperature mapping studies
• Media fill validation principles and execution
• Basic risk assessment techniques (FMEA approach)
• Validation documentation management and report compilation
• Use of validation management software and electronic documentation systems
• Coordination and management of end-to-end qualification/validation activities

Qualifications

• M.Sc./ B.Pharm/ M.Pharm with minimum 7-9 years of relevant experience
• Hands-on experience in Qualification/Validation function within an injectable pharmaceutical manufacturing environment