Plant Quality Leader

Becton Dickinson

4 - 7 years

6 - 9 Lacs

rewari

Posted:1 day ago| Platform:

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Skills Required

manpower handling operations quality control production manufacturing equipment production planning plant operations

Work Mode

Work from Office

Job Type

Full Time

Job Description

Develop and implement a comprehensive Quality Management System to ensure compliance with regulatory requirements.
Conduct audits and assessments to identify areas for improvement and implement corrective actions.
Collaborate with cross-functional teams to design and validate test methods for quality and microbiology testing.
Ensure on-time and effective testing of incoming material, in-process material, and finished products.
Implement and maintain quality systems for all aspects of plant operations, including ISO 9001 and ISO 13485.
Assist with supplier and internal audits to evaluate the effectiveness of Quality Systems and Good Manufacturing Practices.
Ensure development and maintenance of quality systems for all plant operations, including ISO 9001 and ISO 13485.
Handle corporate quality audits and quality control activities.
Ensure timely release of all products from the plant and continuous improvement of lab practices in line with Good Laboratory Practices.
Ensure adherence to Change Control processes for all material, process, and product-related changes.
Ensure regulatory compliance for the plant and availability of manufacturing licenses for products.
Manage regulatory inspections and certifications from India and other countries/agencies, while maintaining batch records for products.
Support the introduction of new products and processes through effective process validation and upgrading the Quality System.
Ensure Change Control processes from initiation to end ECO release and effective validation of manufacturing and test processes.
Implement MSA (Measurement System Analysis) for CTQs and facilitate root cause analysis for major process and product failures, implementing effective and sustainable corrective and preventive actions.
Establish and maintain product quality plans, control plans, process FMEA, validation or re-validation plans, and product quality performance review and trending data for continuous improvement efforts.
Ensure validation/revalidation of sterilization and calibration of quality assurance equipment, while monitoring environments in clean rooms.
Analyze customer complaints, conduct trending, and provide timely redressal.
Provide leadership and guidance to the quality team and ensure timely performance evaluations.
Drive team building and associate engagement initiatives and develop validation capabilities for the plant, leading VRB initiatives.

Job Requirements

Minimum 10 years of experience in quality assurance and process validation.
Strong knowledge of ISO 9001, ISO 13485, and other relevant regulations.
Excellent leadership, communication, and problem-solving skills.
Ability to work in a fast-paced environment and prioritize tasks effectively.
Strong analytical and troubleshooting skills, with attention to detail.
Experience in managing and developing a quality team.
A graduate degree is required for this position.

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