Gmp Auditor Job in Pharmazones

Gmp Auditor

Pharmazones 4+ weeks ago

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Job Summary

Preparation and implementation of Quality management System
Preparation of all the master documents like Site Master File, Validation Master Plan, Quality Manual, Risk Analysis Documents, User Requirement Specifications, Standard operating procedures, Qualification / Validation protocols, Training Modules, Batch Manufacturing and Packing Record
Execution of Project Validation Master Plan
Installation and qualification of all the high end and sophisticated instruments like HPLC, GC, AAS, UV, IR, Stability Chambers, Incubators etc along with their operation and calibration procedure documents
To impart training to employees on basic GMP, Data Integrity, and Quality systems & maintain the records.
Performing Gap Assessment of Formulation & API facilities to evaluate the compliance as per Regulatory requirements of USFDA, MHRA, EU etc.
Qualification

Qualification of all the critical utilities like Compressed Air, Purified Water and HVAC

Qualification of all the production equipments and machines

Qualification of all the QC Instruments and Equipments

Process validations

Cleaning Validation

Analytical Method Validation

Audit (Formulation, Raw Material (API / Excipients), Packing Material & Service Providers) for evaluation of cGMP compliance as per USFDA, MHRA, PICS, WHO, ICH Q-7 & EU-GMP( Eudralex Part 2)
Participating in Regulatory audits and subsequent compliance submission.
Timely submission of audit report & review of Compliance Report submitted by vendor
Technology transfer from one plant to another plant
Imparting training to the interdepartmental candidates on day to day Regulatory updates & over Quality System
Preparation / review of technical agreement
Implementing the QBD (Quality by Design) in Formulation Development and in API Development.
Preparation and implementation of Quality management System
Review of change control report, deviation report, vendor audit reports, Self inspection reports

Experience Required :

3 to 5 Years

Vacancy :

2 - 4 Hires