Manager–Supplier Quality Assurance

Job description

JOB DESCRIPTION:

Primary objectives

·  Proper approval and maintenance of compliance status as per Regulatory and Abbott requirements for TPM.
·  Conduct Qualification audits and surveillance audits for raw materials and packaging materials as per Abbott requirements and defined frequency.
·  Maintain Approved Supplier List
·  Ensure compliance to Abbott Quality System and  GMP requirements for Suppliers/TPM
·  Guidance and performance management of reporting staff

                     

KEY TASKS

EXPECTED RESULTS

CONTROL INFORMATION

TPM :

Approval & compliance at TPM :

Ensure all the Abbott guidelines are followed for approval of TPM and “Compliant” status is maintained thereafter.

Ensure Abbott guidelines and Regulatory requirements are compliant at the time of approval and there after, till the end of Abbott contract.

Approval documents, audit reports

Batch Right First Time :

For all batches produced / packed at TPM, define Quality plan & ensure compliance.

Ensure Compliance to set standards of a Batch Release.

BRFT 100%

Line Non-conformance

No line rejections during the process at TPM.

Rejection summary

Process Parameters :

Define  correct Process parameters and get them approved

To train personnel on operation.

To impart scientific knowledge about the operations performed.

Active participation from line

Operators.

Correct processing conditions

To impart timely information to all concerned

To reduce mistakes during working.

To encourage employees to think & implement quality.

Plant operation manual

Review Log sheets

BRFT report

Suggestions Register

Incoming materials :

Define and Implement Quality Plan for incoming RM / PM. Define and implement Quality plan for incoming goods recd from Jhagadia factory for secondary packaging.

Highlight any deviations observed

Take appropriate Action plan & follow-up

Log book

Update management

KEY TASKS

EXPECTED RESULTS

CONTROL INFORMATION

Consumer Complaints :

Report any deviations observed in goods recd from Jhagadia plant for secondary packaging. Initiate investigation on any consumer complaints from the market.

Monitor complaint trends.

Initiate corrective measures for complaints.

Follow-up on corrective actions

Reduction in consumer complaints

Liaison with R&D for any New Product Initiatives and transfer of technical aspects to TPM

Successful transfer of New Products into TPM

No Non-conformance

GMP and Quality System implementation:

Conduct rounds in plant to point out improvements in cleaning

Training on GMP

Results trends on EB/S etc.

Extraneous matter control

Establish weekly/monthly reports

Validated CIP/COP and contamination free production

No recurrence of mistakes  

Well-informed work-force

No product contamination

Summary   shared with the operators /Management

Cleaning summary.

Training Report

QMR

Zero Rejection

QMR

Implement Hygiene and Pest Control at the facility.

Build required resources for analyses including GLP.

Ensure Food safety

Monitor & compliance to analytical results.

Monthly Review

Monthly Review

                                                             

KEY TASKS

EXPECTED RESULTS

CONTROL INFORMATION

Costing and line efficiency/performance  :

Losses within budgeted values and continuous improvements

Define the line operational standards

As per SCB

Compliance and continuous improvement

MIS report

TPM’s supplier control  :

Conduct survey Ensure compliance and continuous improvement Provide alternative /complimentary  sourcing plan

Correct and technically sound sourcing plan

 MIS report

Supplier Quality Assurance :

·  Provide inputs to Purchase for ingredient qualification / selection.
·  Lead & Co-ordinate QA initiatives related at Suppliers
·  Ensure execution of ingredient qualification as per plan
·  Liaison with Division, suppliers, internal stakeholders for follow-up of action plan.
·  Support NPI related qualifications for new ingredients
·  Execution of supplier audits under qualification & surveillance program
·  Verify CAPA of suppliers for all events
·  Ensure sustainability of incoming ingredients
·  Support Technical development for suppliers

Completion of Audits

ASL up-dation

GIQT projects closure

Reduction of ER’s related to RM/PM

GIQT

ASL

                                                             

                                                             

Chemical Contaminants:

·  Act as contact point for all chemical contaminant alerts and define strategy for the market.
·  Define / propose guidelines & policies after consultation with stakeholders for any deviations.
·  Lead Global Shield program

Completion of testing

RCA for any deviation

Contaminants database

GMP & Quality System Implementation:

·  Conduct rounds in plant to point out improvements in cleaning

·  Training on GMP
·  Results trends on EB/S etc.
·  Extraneous matter control
·  Establish weekly/monthly reports

Validated CIP/COP and contamination free production

No recurrence of mistakes  

Well-informed work-force

No product contamination

Summary   shared with the operators /Management

Cleaning summary.

Training Report

QMR

Zero Rejection

  QMR

Guidance and performance management of reporting staff for TPM&SQA areas :

·  Recruitment of staff
·  Performance Management
·  Internal and external customer satisfaction

Qualification and experience should be relevant

Provide Job description, goals training, resources and timely feedback

Ensure requirements are understood and delivered

workday

customer feedback

     

The base pay for this position is
N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

ANSC Nutrition Supply Chain

        

LOCATION:

India > Mumbai : BKC Building

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 50 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)