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Company Name: Johnson & Johnson Private LimitedPost Name: Product & Process Quality Lead
Qualification: Graduate in Pharmaceutical Sciences / Postgraduate in Science / Bachelors in Engg
experience: minimum 5-7 years relevant experience in Quality Assurance / Quality Control function in Pharmaceutical/ Medical Device industry.
Location: Aurangabad, India
Roles & Responsibilities
- Ensure Product & Process Quality operations are in compliance with applicable regulations and policies, including FDA, safety and environment and ensure that Good Manufacturing Practices (GMP) are followed on shop floor.
- Has Knowledge and experience of Process validations, Facilities validation, Microbiology & QC Test Method Validations.
- Has Knowledge and experience in Change Control, BOM processes & SAP system.
- Mentor, train and supervise the Product & Process Quality staff.
- Improve the efficiency of the Product & Process Quality using process excellence and lean principle .
- Communicate department objectives and metrics.
- Develop and analyze statistical data and product specifications to determine present standards and establish proposed quality and reliability expectancy of the finished products, including raw materials, in-process and finished goods.
- Assure personnel is properly trained and developed for their function and future responsibilities.
- Communicate metrics and systems used to measure and guide improvements to product and system quality and customer satisfaction to quality assurance staff.
- Ensure resolution of daily Product & Process Quality issues, inter and intra department.
- Provide inputs to Product & Process Quality reports, requirements and other information in response to requests for proposals, quotes and other business opportunities.
- Review of Sterilization records for autoclave and EO sterilization.
- Make recommendations to management regarding ways to improve manufacturing processes and increase product quality and delivery while reducing production costs.
- Responsible for revision/creation of documents like SOP & QAP required for manufacturing the product.
- Ensure the correctness and availability of the artwork (Product Graphics) to enhance market acceptability.
- Ensure compliance with Quality System requirements.
- Utilize problem-solving skills and statistical techniques to support product/processes control that is aligned with the overall quality and business vision.
- To represent Product & Process Quality function and provides technical support and information to production and Utilize cost control initiatives to reduce expenses.
- Responsible for managing overall site Product & Process Quality Program in compliance with all applicable regulations and policies, including FDA, safety and environmental.
- Responsible to formulate, coordinate and meet Product & Process Quality objectives & strategies.
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