Abbott Hiring for SR. EXECUTIVE-QA-CI LEAD

MAJOR RESPONSIBILITIES

• 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.

• Support in achieving Internal Audits Schedule adherence and on-time closing of Action Plans.

• Train relevant Team members on new CAPA management tool.            

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

• Drive Quality Improvement Projects to reduce the Cost of Quality (COQ) in various manufacturing / lab processes.

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

• Drive the POP Improvement Programme through cross-functional team alignment.

• 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.

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

• Identification of the Cost of Quality (COQ) improvement areas in various Manufacturing & Lab process & Drive COQP with Cross Function & Review Improvements with Management.

• Support to Drive site Protect our Product (POP) Program to Enrich Site Food Safety Culture by Quality awareness at the shopfloor through training, Quality Circle and supporting Quality campaign for improving the shopfloor engagement. Involve with event owner to support thorough investigation for POP (Micro, Pest, EM, and Package Integrity) and Critical incidents.

• 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, Lead Improvement Projects of PoP, Lean Six Sigma Initiatives, Ideas, Kaizens and CI Metrics for the department.

• Identify and facilitate process improvement projects, training/ workshops to drive cultural change.

• 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

• 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.

• 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.