This is a position required to handle sterile-related audits and qualifications based on the current business requirements.
Job Description Summary
This job position is responsible for performing audits globally for vendors [Sterile API, Packaging (Sterile / Non-Sterile), Excipients & Sterile Consumables] and service providers as a part of the vendor qualification program.
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Responsible to perform audits of external CMO (Contract Manufacturing Organization) for sterile manufacturing - SVP (Small Volume Parental), LVP (Large Volume Parental), Biologics & combination products globally as per the current guideline requirement
Responsible for ensuring GMP compliance at site by executing corporate audits of Sterile formulations sites as an SME for sterile operation
Perform external vendor audits pertains to Sterile API, Packaging (sterile and non-sterile), sterile consumables & Excipient.
Perform external CMO audits for sterile manufacturing - SVP (Small Volume Parental), LVP (Large Volume Parental), Biologics & combination products globally as per the current guideline requirement.
Perform service provider audits of Contract Service Providers & contract packaging.
Ensuring GMP compliance at site by executing corporate audits of Sterile formulations sites.
Timely escalation to the management for any risk noticed during audit. Ensure implementation of CAPA for the performed audit in timely manner.
To review and ensure all documentation pertaining to Vendor qualification of suppliers, consumable & service provider for all PAR India sites particular to sterility assurance.
To execute, review and follow-up for completion of technical agreement pertaining to supplier & service provider.
Approving and maintaining the manufacturer/ supplier in SAP.
Handle respective QMS documentation within this function.
To support manufacturing site as sterile SME during regulatory inspection.
Education & Experience:
Master's in science (Microbiology) / Master in Pharma. Microbiology is preferable.
Hands on experience in sterile formulation unit (Manufacturing, Quality, Sterility Assurance & Validation).
Experience in vendor (Sterile and Non-sterile) auditing & supplier qualification
Minimum experience: 10 to 14 Years
