Quality Excellence and Documentation Manager

Manager Quality Excellence and documentation

     

JOB DESCRIPTION:

This role is to support the Quality function, driving Operational Excellence in collaborating with multiple stakeholders to drive a culture of systematic Quality management and continuous improvements aligned with Abbott strategy and objectives.

• To manage, review and improve of Quality and Food Safety requirements through “Excellence culture"

• The job holder accountable for driving the Projects of Quality department and ensure on-time delivery as expected

•Lead and promote QualEx program and implement division Qualex project in plant. Looking for Quality improvement opportunities and convert into projects

Liasoning with division Qualex and OPEX functions and coordinating with site OPEX stakeholders

The job holder is responsible to develop good documentation practices in the plant and accountable for document control and document change management of all functions within Abbott Nutrition Jhagadia.

Lead the project metrics and govern the progress of the projects involving the QA function , lioasoning with the cross functions and act as an interface

Lead and track the metrics related to PRFT , coordinate and liase with site stakeholders to improve the PRFT , govern the gold star projects and track the progress

Govern and track the CIP projects , hold regular connects with in the QA function to track the update the CIP progress . Act as an interface with finance

 Act as a QA MOS owner and lead the MOS activities

Major Responsibilities and Authorities:

Evaluating, ideating, conceptualizing and driving strategic initiatives and projects.

• Identify failure modes in current processes and work closely with stakeholder teams to solve the chronic problems and finding long term solutions

• Driving continuous improvement in efficiency, Cost and effectiveness of processes

• Drive Statistical Process Capability/ 6 Sigma / Quality Circle to drive continual improvement in Quality and Food Safety compliances

• Champions project governance and execution of assigned projects

• Ensures risk assessments are completed and that contingency plans are identified and executed

• Support the team in the improvement of the quality and the process improvement initiatives

• Coordinate and drive the inherence program for raw materials as per JH15QA007 and AN15-03-007. Also support for any change in the inherence program .

• Delivery through matrix management systems and driving a culture of continuous improvement.

• Maintenance of Documentaion for Quality management system and work closely with the factory document controller in managing the Quality documents / records/ VMS/DMS / statutory requirements

• QA MIS data compilation & coordination with the concerned departments for taking the corrective/ preventive action.

•Organize regular department project review meeting to ensure project health.

• Lead T5 , all visual KPI boards and related activities at site

• To manage all initiatives associated with the GQP, GQMP & Quality policy, EHS & compliance at site.

• To support in preparation of Opex & Capex budgets for QA function, making the proposal and close follow-up of execution of new and exisitng projects .

To support the QA CIP projects .

• Ensure all the requirements as per the QMS elements and implementing the updated requirements in Quality Assurance to improve & sustain the systems

 Provide necessary direct & indirect support for presenting required documents during internal or external audit.                    

Support to Conduct gap analysis for corporate and division policies, site level documents and regulatory requirements applicable to site and develop action plan to close the gap and mititgate risk

Support QA compliance in BIS / regulatory audits and related documentation

Perform document control activities inlcuding processing of Document change controls, review, approval and filing of completed documents in line with global requirements

Ensure adherence to document retention as per Abbott policies.

nsure Periodic review for site document/Multi site effectivity of global documents is completed by respective site subject matter expert

Provide documentation support to inter department teams to ensure compliance to global documentation requirements.

Lead the project metrics and govern the progress of the projects involving the QA function , lioasoning with the cross functions and act as an interface

Lead and track the metrics related to PRFT , coordinate and liase with site stakeholders to improve the PRFT , govern the gold star projects and track the progress

Govern and track the CIP projects , hold regular connects with in the QA function to track the update the CIP progress . Act as an interface with finance

 Act as a QA MOS owner and lead the MOS activities.

Education Background:

Post Graduate/Graduate  Degree in Pharma/ Dairy or Food Sciences or related field like Master’s Degree in science with 10 to 12 years of experience in quality control or quality assurance function.

Accountability/Scope:

• Understanding of Quality systems ISO 9001/ISO 22000/ FSSAI /BIS / Risk Assessment, conducting Internal Audits and exposure for HAZOP/HACCP/Food Safety systems is desirable.

• Knowledge of regulatory, statutory and corporate policies

• Understanding of Quality systems ISO 9001/ISO 22000/ FSSAI /BIS / Risk Assessment, conducting Internal Audits and exposure for HAZOP/HACCP/Food Safety systems is desirable.

• Knowledge of regulatory, statutory and corporate policies

     

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 > Jhagadia : Operation Support

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 25 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

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

     

     

     

Experience Level

Senior Level