Quality Analyst

POSITION SUMMARY STATEMENT (defines the major functions/purpose of the position)

NFTE is responsible for ensuring compliance (cGMP & GSP) and sustainability of various checks and controls, CAPA implemented at various lines at contract manufacturing sites. The position will be responsible to support Site team to facilitate and review the investigations to ensure actual root cause and effectiveness of CAPA implemented on shop floor. This position will provide routine status updates to his manager.

DETAILED RESPONSIBILITIES/DUTIES:

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 as per Batch records and to ensure Herbalife requirements have been fulfilled during manufacturing and packaging activities. Monitoring of CCPs, Metal detector, Induction sealer, Xray machine)
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.
• 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 of Market feedback/NCR.
Track open investigation & action items and ensure timely closure.
• Compilation of daily observations at shop floor and CAPA implemented.

Review of material reconciliation & daily reporting.
• 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
• Coordination with Cross functional team. Verification of closed action items and checking effectiveness and sustenance of implemented actions.

SUPERVISORY RESPONSIBILITIES:

• Work with Contract Manufacturing team.
• Follow up for all observation closure in time.

ORGANIZATIONAL RELATIONSHIPS:

MINIMUM QUALIFICATIONS: The following are the minimum qualifications which an individual needs in order to successfully perform the duties and responsibilities of this position.

Education: Graduate-Food technology, M.Pharma/ B. Pharma, Nutrition Science, Mechanical with Food industry experience

Roles & Responsibility : Covered above

Skills :-

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

Experience:

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

PHYSICAL DEMANDS: In general, the following physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.

(Check One by double clicking on the box:)

Sedentary: Limited activity, no lifting, limited walking Moderate: Mostly standing, walking, bending, frequent lifting

Light: Office work, some lifting, considerable walking Arduous: Heavy lifting, bending, crawling, climbing

WORK ENVIRONMENT: In general, the following conditions of the work environment are representative of those that an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job within the environment.

I have read and understand the essential functions of the job and know that other duties may be assigned and/or changed at any time.

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