Job Description Summary

- To develop, implement, drive, sustain and continuously improve an effective Quality Management System for the Plant in line with BD WW norms, ISO, CE. Ensuring compliance to all quality assurance activities, regulatory and corporate requirements are complied with for all products manufactured in the Plant and release products which are compliant to above standards.
- To build, implement, drive, sustain and continuously improve process validation and control capabilities for existing as well as new products to achieve product quality in compliance to BD’s Standards and Regulatory
requirements in line with BD WW norms, ISO, CE.
- To ensure that plant meets all needed regulatory compliance and continue to upgrade compliance standard

Job Description

Responsibilities include but are not limited to:

Quality Assurance to enhance quality standards of plant
1. Ensure Development & maintenance of quality system for all aspects of plant operations including 1SO 9001, ISO 13485.
2. Assists with supplier and internal audits, as a means of evaluating the effectiveness of the established Quality Systems and Good Manufacturing Practices
3. Corporate Quality Audits
Quality Control
1. Ensure on-time and effective testing of incoming material, in-process material and finished product
2. Ensure microbiology testing and quality testing for raw material, packaged material, assembled
components, finished goods etc. and stability studies
3. Ensuring on time release of all products from plant
4. Ensure design & validate test methods for quality and microbiology testing
5. Ensuring lab practices are improved continuously in line with Good Laboratory Practices
6. Ensuring that Change Control process is followed for all material, process & product related changes.
Regulatory Compliance
1. Ensure Corporate and regulatory compliance of the product
2. Ensure availability of new or renewed manufacturing license for products
3. Handling Regulatory inspection & certification from India as well as other countries/agencies
4. Ensure proper maintenance of batch records for products.
Process Validation, Change Control, Sterilization Validation and Clean Room Testing
1. Supporting introduction of new product & processes by effective process validation and upgrading Bawal's Quality System to support new products.
2. Ensure Change Control process from initiation to end, till ECO release.
3. Ensure effective validation of manufacturing & test processes
4. Ensure implementation MSA (Measurement System Analysis) for CTQs.
5. Well conversant with Root Cause Analysis techniques. Facilitate route cause analysis for major process
and product failures, implement effective and sustainable corrective and preventive actions.
6. Ensure Establishment and maintenance of product quality plan, control plan, process FMEA, validation or re-validation plan, product quality performance review and trending data for the processes and for continuous improvement efforts.
7. Ensure Validation / revalidation of sterilization
8. Ensure Validation / calibration of quality assurance equipment
9. Ensure Environment monitoring for clean rooms.

Customer Complaint
1. Customer complaint Analysis, trending and adequate & timely redressal

People development
1. Provide leadership and guidance to quality team
2. Ensure timely Performance Evaluation
3. Driving Team building and associate engagement initiatives
4. Develop validation capability for plant and leading VRB initiative

Required Skills

Optional Skills

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Primary Work Location

IND Rewari - Bawal

Additional Locations

Work Shift