Sr. Executive-QA-CI lead, Abbott

WHO WE ARE

We’re dedicated to fulfilling the promise of human potential, in all places, in all aspects and stages of life. We believe that health is the key to that promise. Because at our healthiest, we’re capable of achieving anything. And that’s why our pursuit of helping people achieve their best health at every life stage will never end. This is how we put that belief into practice each and every day.

OUR PROMISE
We are here for the people we serve in their pursuit of healthy lives. This has been the way of Abbott for more than a century—passionately and thoughtfully translating science into lasting contributions to health.

Our products encircle life, from newborns to aging adults, from nutrition and diagnostics through medical care and pharmaceutical therapy.

Caring is central to the work we do and defines our responsibility to those we serve.

  • We advance leading-edge science and technologies that hold the potential for significant improvements to health and to the practice of health care.
  • We value our diversity—that of our products, technologies, markets and people—and believe that diverse perspectives combined with shared goals inspire new ideas and better ways of addressing changing health needs.
  • We focus on exceptional performance—a hallmark of Abbott people worldwide—demanding of ourselves and each other because our work impacts people’s lives.
  • We strive to earn the trust of those we serve by committing to the highest standards of quality, excellence in personal relationships, and behavior characterized by honesty, fairness and integrity.
  • We sustain success—for our business and the people we serve—by staying true to key tenets upon which our company was founded over a century ago: innovative care and a desire to make a meaningful difference in all that we do.

The promise of our company is in the promise that our work holds for health and life.

Since 1910, Abbott has been dedicated to helping people in India live healthier lives through a diverse range of science-based nutritional products, diagnostic tools, branded generic pharmaceuticals, and diabetes and vascular devices.

Headquartered in Mumbai, Abbott India Limited, a publicly listed company and a subsidiary of Abbott Laboratories, takes pride in offering high-quality trusted medicines in multiple therapeutic categories such as women’s health, gastroenterology, cardiology, metabolic disorders and primary care.

One of India’s fastest-growing pharmaceutical companies, Abbott India Limited is part of Abbott’s global pharmaceutical business in India.

We have expertise across product development, manufacturing, sales and customer service and are dedicated to providing high-quality, reliable products with the expert clinical support our customers need.

Abbott India Limited believes in providing quality healthcare through a mix of global and local products for people in India. Our in-house development and medical teams undertake product and clinical development tailored to the unique needs of the Indian market. Our employees work to produce high-quality, high-volume formulations using cost efficient processes. And, our trained personnel are dedicated to ensuring compliance with international quality standards.

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.

QUALIFICATION/BACKGROUND

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

Qualification: M.Sc., Biotechnology, Food Technology, Dairy Technology

  • Knowledge of Quality & Food Safety management, Documentation, Basic, Computer Knowledge, Auditing Skills, FSSC 22000, ISO 9001, FSSAI, BIS, HALAL, Regulatory & 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

Comments

  • Suresh Kumar Punna
    August 22, 2022

    MSc in Food Technology with 12 years of rich experience in Bakery, confectionery, chocolate Industries,
    Currently working with Britannia industries pvt Ltd as a Regional Quality Assurance officer for Hyderabad region – 8 CMUs in Hyderabad region.

  • Birbrata Chowdhury
    August 22, 2022

    I am interested for your company

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