BD (Becton, Dickinson and Company) Assistant Manager, Quality Assurance in Rewari, India

Job Description Summary

• Quality leadership position supporting the plant quality manager in ensuring products are manufactured to specifications and within compliance to relevant regulations and standards.

• To develop, implement, drive, sustain and continuously improve an effective Quality Management System for the Plant in line with corporate policies and relevant regulations.

• Oversee all aspects of quality to achieve product quality in compliance to BD’s Standards and Regulatory Requirements. To ensure that plant meets all needed regulatory compliance and continue to upgrade compliance standard.

Job Description

Principal Accountabilities

1. Quality Assurance to enhance quality standards of plant

  • Ensure Development & maintenance of quality system for all aspects of plant operations including ISO 13485

  • Planning and organizing resources for incoming inspection, routine testing of production process outputs and lot releases for all manufactured products

  • Participation in Corporate Quality Audits.

%

20

2. Quality Control

  • Ensure on-time and effective testing of incoming material, in-process material and finished product

  • Ensuring on time release of all products from plant

  • Ensuring lab practices are improved continuously in line with Good Laboratory Practices

  • Ensuring that Change Control process is followed for all material, process & product related changes

  • Ensure Validation/Calibration of inspection equipment

  • Ensure design & validate test methods for quality and microbiology testing

20

3. Regulatory Compliance

  • Ensure implementation of QMS, BD WW and Regulatory requirements

  • Ensuring lab practices are improved continuously in line with Good Laboratory Practices

  • Ensure establishment of SOP’s for inspection and testing in the quality labs

  • Ensure proper maintenance of batch records for products

20

4. Process Validation, Change Control, Sterilization Validation and Clean Room Testing

  • Supporting introduction of new product & processes by effective process validation and upgrading Bawal's Quality System to support new products

  • Ensure Validation / revalidation of sterilization

  • Ensure Validation / calibration of quality assurance equipment

  • Ensure Environment monitoring for clean rooms

20

5. People development

  • Provide leadership, development and guidance to QC team

  • Ensure timely Performance Evaluation

  • Driving Team building and associate engagement initiatives

  • Drive multiskilling to mitigate risk due to attrition

20

3. Critical Challenges

  • Ensure quality standard are met & continuous up gradation of quality standards

  • Ensure compliance to relevant regulatory standards

  • Complete understanding of statistical tools and application to process for quality improvements

  • Complete understanding of the product value stream to drive improvement in product quality

  • Develop systems, policies, procedures and work instructions for both current & future products at par with the relevant standards

  • Understanding customer requirements both internal / external and ability to take action to meet the requirements

  • Ability to effectively manage a team of associates and ability to develop people

  • Working in cross functional/cross culture environments

Unique Knowledge & Skills

  • Planning, analyzing and executing skills

  • Effective communication & interpersonal skills

  • Knowledge of Industry Standards & Regulations

  • Knowledge of ISO and other quality standards

  • Networking with WW BD plants & corporate resources

  • Exposure to Validation, Statistical Quality Control and Statistical Process Control

  • Effective analytical and problem solving skills

  • Six Sigma knowledge

  • People Development

  • Leadership and supervisory skills- should have worked in Cross Functional Teams/projects

  • Adaptability to new & dynamic situations and flexible to change

Primary Work Location

IND Rewari - Bawal

Additional Locations

Work Shift

BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.