Job Description

JOB DESCRIPTION:

Primary Function/Primary Goals/Objectives:

To Sustain Quality Food Safety Assurance & Compliance of QA Operations

Describe the primary goals. objectives or functions or outputs of this position.

Major Responsibilities:

1) Customer Complaint management

• Responsible for implementing and maintaining effectiveness of the Quality & Food Safety Management System

• Coordinates the complaint investigation process for the plant in compliance with Local Regulations and Abbott policies and procedures.

• Reviews batch records, complaint investigations, physical samples, and trend evaluation for inclusion of appropriate documentation in the investigation of the complaint.

• Notifies appropriate management (plant and division) of noted trends

• Assure results of the batch records and investigation information is entered accurately into the Complaint Handling Unit database within the prescribed timeframes, Customer complaint evaluation, investigation and closure in Track wise system & Coordinate with cross functional stakeholders for effective evaluation of customer complaints

2) Continuous Improvement (QA \xe2\x80\x93 CI)

• Drive the Quality Culture at the site through People engagement & active Quality Campaign.

• Is an effective member of a multifunctional team, ensuring that all communications, interpersonal interactions and business behaviors are consistent with the Abbott Code of Conduct.

• Drive all OpEx initiatives to create sustainable Continuous Improvement Culture being a Functional CI Lead.

3.CAPA Coordinator:

• To manage, review and support to improve of Quality of Investigations & CAPA for the Manufacturing Operation.

• Ensure Global Impact Assessment Review by working closely with other functional areas, identify Improvement areas, support in Implementation & execution of the Actions & share the report with divisional team.

• Train relevant Team members on new CAPA management tool.

• Support in CAPA investigations, effectiveness review during PNC / NC & critical quality issues.

Education:

M. Sc / B.E / B.Tech, Biotechnology, Food Technology, Dairy Technology/Masters in relevant Field

Background:

• Experience : 7 to 10 years of relevant experience in Food / Pharma Industry in Manufacturing Environement.

• Knowledge of Quality & Food Safety management, Documentation, Basic, Computer Knowledge, Auditing Skills, FSSC 22000, ISO 9001, FSSAI, BIS, HALAL, Regulaoty & Statutory Requirement Applicable to Food Industry

• 6 Sigma / Lean / Quality Circle : Black / Great Belt Project implementation

• Process Innovation Skills, Decision Making Abilities

• Able to apply strategic and quality logic and project management skills to investigation activities ensuring appropriate investigations are conducted.

• Good project management skills to deliver an effective service in a timely manner.

• Attention to detail to ensure accuracy of work that forms part of the Quality System documentation.

• Good written and oral communication skills to ensure effective and succinct report generation, and effective communication with staff at all levels of the organization.

• Able to work independently & within Multifunctional Team to deliver Organization Expectations

Accountability/Scope:

• Regular tracking and trending of complaints as per set procedure

• Escalate abnormal trend to plant management for possible product actions as necessary, work with stakeholders for detailed evaluation of complaints and closing in system

• Share complaint trend with management during monthly review meetings

• Raise QR\'s for detail complaint investigation depending on complaint trend

• Closing of complaint in Trackwise system as per defined timeline

• Maintains effective communication with Corporate, Division, and Operations/QA Management

• Generates reports from databases and other systems, Addresses complaint information provided by the Abbott Nutrition Complaint Handling Unit, Addresses potential high impact complaints where a potential broader issue is identified

• Evaluates physical sample (field/reference), Reviews Batch Records, Coordinates and distributes investigations to the subject matter experts (SME), Maintains and tracks Plant Investigations via the site tracking system in a timely manner

• Use ABTRAQ for investigations for complaints (Initiation \xe2\x80\x93 Event Owner status), Participate in on market events and Division Complaint meetings

• Complete Plant Investigation files/records, Work additional hours on rush complaints, if necessary

• Works to ensure that actions are on time, thorough, complete, meet the needs of the business and customers, and that required standards and/or procedural requirements are met.

• Facilitates the investigation process to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance

• Supports a work environment that ensures team effectiveness by demonstrating full cross functional team support that complies with Corporate and regulatory requirements.

• Supports the attainment of division goals and objectives.

Ensure 100% CAPA Metrics by Evaluation and progression of timely completion of CAPA system activities, including effectiveness checks, raised for non-conformances, potential non-conformances, and/or deviations, as output from the division\xe2\x80\x99s Quality System & to ensure timely closure linked to Batch Release by Working closely with Medical, Regulatory, Design Assurance and Micro team to assess the event for supporting the impact assessment and batch disposition decision.

• Works closely with other functional areas with the use of investigational tools, to determine the root cause of any nonconformity, ensure that CAPA plans address root causes, and ensure that CA/PAs are implemented to facilitate the rapid, compliant, introduction of new/improved products, processes, and systems.

• Works to ensure that actions are on time, thorough, complete, meet the needs of the business and customers, and that required standards and/or procedural requirements are met.

• Facilitates the investigation process to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance & Lead Site Human Reliability Program by Periodic Assessment to reduce Human Error

• Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area.

• Support in achieving Internal Audits Schedule adherence and on-time closing of Action Plans, area audits and GDP audit schedule, Supplier / Key Service Provider Audits

• Compile, analyze and report CAPA metrics data for Daily Tracking, Weekly Deck, Fortnightly, Monthly & QMRM for Tier & Governance Meeting.

• Ensure Training Compliance of CAPA for site & Technical Support for CAPA improvement, Ideas, Kaizens and CI Metrics for the department.

• Initiate & Ensure Global Impact Assessment Review for CAPA and submit report to Division as per Global CAPA Assessment timelines.

• Ensure all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner

• Accountable to the Quality Organization for achieving mutually agreed upon objectives.

• Supports other organizations in the management of their CAPA actions and provide additional confidence that investigations are initiated and completed in a complete, concise, and timely manner; and that viable corrective actions are identified and implemented to address any non-conformances

• The CAPA System is a key inspection focus of worldwide regulators and auditors & The system must be usable, simple, sustainable and well maintained.

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: No

MEDICAL SURVEILLANCE: No

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

Abbott