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