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

　　An Equal Opportunity Employer

　　Abbot welcomes and encourages diversity in our workforce.

　　We provide reasonable accommodation to qualified individuals with disabilities.

　　To request accommodation, please call 224-667-4913 or email [email protected]