Overview

POSITION SUMMARY STATEMENT

The process compliance Sr. Officer, Manufacturing is responsible for ensuring compliance (cGMP & GSP) and sustainability of various checks and controls, CAPA implemented at various lines at contract manufacturing sites. This position will provide trainings to CM staff as per the Herbalife requirement. The position will be responsible to manage, facilitate and review the investigations to ensure actual root cause and effectiveness of CAPA implemented and to track the open investigations process. This position will provide routine status updates to his manager.

Sr.Officer, Process Compliance -Manufacturing

To ensure cGMP and GSP compliances at CM sites.
Monitoring of shop floor activities.

GMP rounds of shop floor, warehouses, and service areas.

Review of Manufacturing and packaging activities and to ensure Herbalife requirements have been fulfilled during manufacturing and packaging activities.

Verification of in-process parameters of powder manufacturing & packaging, Granulation, Compression, coating, Capsule filling, Counter filling (Tablet & Capsule), stick packing.

To support CMs with troubleshooting (if any) during manufacturing and packaging activities.

Designing/drafting/review of batch documents.

Manage, facilitate, document, and review investigations to ensure root causes are identified, corrective actions implemented, and the effectiveness of these corrective actions fulfil cGMP and business requirements.

Conduct investigation for non-conformances along with CMs and Herbalife cross function teams to identify root cause.

To support CMs to identify CAPA and implementation of CAPA.

To check effectiveness of implemented CAPAs.

Track open investigation & action items and ensure timely closure.

Compilation of daily observations at shop floor and CAPA implemented.
Provide routine updates on status of manufacturing investigations to project teams and clients and manage client involvement as required.
Drive visual management process to track progress of open investigations to assure appropriate timelines are met and escalate appropriately to assure all critical timelines are met
Organize all cross functional resources required to support investigation and delegate responsibilities across various functions.

Support OpEx team by providing training to CM teams, verification of closed action items and checking effectiveness and sustenance of implemented actions.

Minimum Qualifications

Education

Graduate- Food Technology, M.Pharmacy, Nutrition Science, Mechanical with Food industry experience

Skills

Result Oriented/Getting things done.
Team Player.
Capable of leading teams of shop floor people
Must be well-versed with Microsoft Office (Word, PowerPoint & Excel)
Good Communication Skills, both written and verbal.

Experience

Minimum 3-5 Years.
Industry Type: Pharma/Nutraceutical/Food
Experience in functions: QA/Manufacturing

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Sr Officer, Production & Process Compliance - India