Senior Manager QA ValidationConfidential • Dahej, India
Senior Manager QA Validation
Confidential • Dahej, India
18 days ago
Job descriptionResponsible to department activity planning related to process validation, cleaning validation and qualification activity. Responsible for Overall Validation and Qualification activities at site. Responsible to review of Calibration certificates and reports. Responsible for review & approval of Instrument specification record, calibration schedule, Preventive Maintenance schedule, validation schedule and other schedule. Activities other than the defined in the Job responsibility are to be done, as per the requirement of HOD, by following HODs instruction and guidance. Bachelors Degree (BA / BS) B. Sc. - Required Bachelors Degree (BA / BS) B. Pharm - Preferred Master Degree (MS / MA) M. Sc. - Preferred Master Degree (MS / MA) M. Pharm - Preferred 15 years or more in 15-17 years Regulatory Compliance & Validation Guidelines (FDA, EMA, ICH, WHO) - Advanced Validation Master Plan (VMP) Development & Execution - Advanced Process Validation (PV) - Expert Cleaning Validation - Expert Equipment Qualification (DQ, IQ, OQ, PQ) - Expert Environmental Monitoring & HVAC Qualification - Expert Computer System Validation (CSV) & Data Integrity - Expert Risk-Based Validation (QbD & PAT Implementation) - Advanced Deviation Handling, CAPA & Change Control in Validation - Advanced Regulatory Inspections & Audit Readiness for Validation - Advanced SOP Updates & Compliance - Advanced Risk Assessment & Failure Mode Analysis - Expert Statistical Data Analysis & Process Capability - Expert GMP Knowledge - Expert GDP Knowledge - Expert Deviation Management - Advanced Change Management - Advanced Report Writing - Advanced Capability Development - Advanced Resource Management - Advanced Manufacturing Process and Equipment Understanding - Advanced Effective Communication - Advanced Continuous Improvement - Advanced Demonstrates leadership - Advanced
Description
JOB DESCRIPTION
The role involves reviewing and executing qualification and validation documents for equipment, facilities, and utilities. Key tasks include preparing validation protocols, coordinating with teams, ensuring c-GMP compliance, and providing training on validation processes.
Essential Functions
- Responsible to review and execution of qualification document related Equipment, Facility and Utility like Plant equipment, HVAC, Water system and Compressed air system.
- Responsible to review and execution of Re-Qualification document.
- Responsible to co-ordinate with manufacturing personnel for respective qualification / validation / Re-qualification activity form timely completion of activity.
- Responsible for preparation, review and execution of risk assessment related tEquipment, System, Facility and Process.
- Responsible for preparation and review of validation master plan tensure execution of activity.
- Responsible for preparation of cleaning validation protocol and compilation and review of cleaning validation report.
- Responsible t0 conduct sampling activity as per the approved cleaning validation protocol.
- Responsible for preparation of process validation protocol and compilation and review of process validation report.
- Responsible for preparation of packaging validation protocol and compilation and review of packaging validation report.
- To co-ordination with Quality control or Micro department for sample preparation and testing for cleaning validation, Equipment, Utilities and System qualification / validation / re-qualification study.
- Responsible to prepare and reviewed SOPs for process validation, Cleaning Validation and Qualification.
- Responsible to impart training of validation / qualification for equipment / system / utilities / process.
- Responsible to review of change control to evaluate validation requirement.
- Responsible to review of deviation and laboratory OOS related to validation.
- Responsible to check c-GMP compliance.
Additional Responsibilities
Education
QUALIFICATIONS
Experience
Skills
Specialized Knowledge : Licenses :
Skills Required
Cleaning Validation, Continuous Improvement, Change Management, Resource Management, deviation management , Report Writing, capability development
Create a job alert for this search
Qa Manager • Dahej, India