Officer – Quality Assurance, Abbott

About us

LIVE YOUR BEST LIFE, NOW AND IN THE FUTURE

We understand that the first step to living your best life is good health. Everything we make is designed to help you do just that. That’s our commitment to building life-changing technologies that keep your heart healthy, nourish your body at every stage of life, help you feel and move better, and bring you information, medicines and breakthroughs to manage your health.

ABBOTT AT A GLANCE

We create breakthrough products – in diagnostics, medical devices, nutrition and branded generic pharmaceuticals – that help you, your family and your community lead healthier lives, full of unlimited possibilities. Today, 113,000 of us are working to make a lasting impact on health in the more than 160 countries we serve.

For more than 130 years, we’ve put science and innovation to work – to create more possibilities for more people through the power of health. We adapt and respond quickly to changes in the world around us to deliver better solutions to help people live their best lives.


WORKING AT ABBOTT

Join our global team helping people live fuller, healthier lives. Every day we strive to reach more people in more places with innovative health technologies. Our goal is to reach 3 billion people each year by 2030. At Abbott you can be part of this, doing work that matters while living your own best life personally and professionally.

Major Responsibilities:

  • On time analysis & release of raw material, in-process samples & finished product samples
  • On time Training completion within predefined timelines.
  • Laboratory standards, chemicals preparation, standardization & stock management.
  • Lab SOP & work instruction review & revision
  • Lab Equipment calibration & preventive maintenance
  • Adhere Abbott safety & quality requirements
  • Lab area 6S, GMP, GLP management• Laboratory consumables stock management etc.

Accountability/Scope:
Primary Functions:

OPERATIONS

  • Ensure right product quality is released to market by carrying out  the timely and accurate analysis of all the finished products in shifts and timely feedback (signals) to Production on quality trends.
  • Responsible for analysis of in-process liquid samples & finished product powder for macro & micro nutrients (protein, fat, moisture, minerals, vitamins etc.).
  • Responsible for operation, calibration & maintenance of equipment as per Abbott & OEM Guidelines.
  • To maintain and upkeep the hygiene, cleanliness and work place safety in the lab.
  • Laboratory SOP & Work instruction review & revision inline with global AN/AQ policies & other relevant governing documents (Including regulatory documents FSSAI,BIS etc.).
  • Participate in product sensory analysis.
  • Implementing, maintaining and improving the established analytical lab and in-process testing process and methods.
  • Monitoring, analyzing and communicating site analytical testing results and productivity, and recommending improvement actions.
  • Participating in site internal audits, Providing professional analytical inputs when any needs from other functions, such as supplier evaluation, validation etc.
  • Managing the analytical lab to assure the EHS compliance, Maintain safe and healthy working conditions for employees under his/her supervision.
  • Attend EHS training assigned and ensure that employees who report to him/her attend required training. •Ensure to submit Near Miss reports and other opportunities to improve the EHS Program. Adhere use of PPE in accordance with all safety rules and practices.
  • Analytical laboratory equipment maintenance and calibration, Analytical reagents, reference standards and glassware procurement and management.
  • Carryout cleaning validations for new equipment and existing equipment and suggest effective methods of cleaning for ensuring right product quality, Support the validation activities in terms of design, operational and performance qualification of the process and laboratory equipment

COST

  • To support in preparation of Opex & Capex budgets for Analytical function, making the proposal and  close follow-up of execution of new and existing projects.

PEOPLE

  • Building and Managing analytical team to assure the capability and stability,  Recommending the structure, roles and responsibilities for the analytical  lab,  Recruiting talents,  Behaving as an example of the analytical staff, Communicating the site goals/metrics, Performing people manager’s activities on setting goals, coaching and reviewing performance, Supporting functional head on building the function structure to achieve the function goals.
  • Promote and support team development activities.
  • Impart training to workmen and staff on GMP requirements and QMS requirements.

COMPLIANCE

  • Implement BIS method where applicable.
  • Preparation of SOPs and work instructions whenever new QMS requirements become effective. Carryout gap analysis of new QMS documents and take actions for their implementation.
  • Ensure that the laboratory operates with calibrated equipment and carryout performance qualifications of the equipment, as per the frequencies.
  • Meet the requirements of EHS/GPCP in handling of Biohazardous waste generated at the laboratory
  • To support the Analytical compliance of ISO 17025, ISO 9001, ISO 22000 and HACCP, BIS, FSSAI requirements in and around the manufacturing facility by regular interaction with all stakeholders.
  • Ensure all the requirements as per the ISO 9000:2000 / QMS elements and implementing the updated requirements in Quality Assurance to improve & sustain the systems.

Education:

  • B.Sc./M.Sc. / MTech in Chemistry (Dairy / Food) with minimum 1-3 years of relevant experience
  • Thorough knowledge of general Analytical analysis procedures.
  • Understanding of Quality systems ISO
  • 9001/ISO 22000/ FSSA /BIS / Risk Assessment and exposure for HAZOP/HACCP analysis.

Background:

  • 1-3 years of experience in a reputed food processing / pharmaceutical industry
  • (Out of which at 1-2 years as QA Executive Analytical Laboratory in similar industry is preferable)
  • Being proficient in Gujarati is advantage.
  • Ability to accurately interpret the quality related problems of ingredients, finished food & process checks in food processing.
  • Ability to conduct trouble shooting studies to resolve the problems encountered w r t Quality and Hygiene/GMP at Site.
  • Ability to handle all type of Analytical quality issues in the entire supply chain.
  • Hands on experience of analytical lab equipment operations. (i.e. HPLC, ICPMS, LCMS, Protein Analyzer, Fat Analyzer, moisture analyzer etc.)

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