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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.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.

. Conduct CRB meeting as per the Policy requirements

Comments: (optional)

Education: M. Sc / B.E / B.Tech, Biotechnology, Food Technology, Dairy Technology

Background: • Experience : 5 to 7years 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:

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’s 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.

• 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.

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 corpjat@abbott.com