Process Technology support, Machine assembly QA

8 - 12 years

0 Lacs

Posted:22 hours ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

As a candidate for the position, your role will involve continuing FDA license, providing guidance and training to improve processes related to Granulation and compression, and troubleshooting process-related challenges both in-house and at customer sites. Additionally, you will be responsible for testing machine performance as per Protocol and carrying out documentation work to maintain records for process optimization. Key Responsibilities: - Aid the level above in setting up trials and tests at various stages and conducting customer trials at the factory - Conduct customer visits to resolve process-related challenges - Perform market surveys and gather information on challenges faced by customers for resolution - Conduct GAP analysis, Root Cause Analysis (RCA), and implement solutions at the site - Suggest customers for formulation changes and provide design-related solutions when required - Carry out in-house validation and on-site validation - Obtain reference letters and facilitate sales by demonstrating machine features at the site - Train customers and internal teams at the site - Prepare a formulation data bank and publish relevant information - Conduct in-house machine testing as per protocol - Ensure continuation of FDA license and related audits Qualifications and Education Requirements: - Bachelors in Pharmacy (B. Pharm) - 8-10 years of relevant experience in the pharma industry (Experience in Pharma production/ R & D) Key Competencies Required: Technical: - Basic understanding of product related characteristics, granulation process, compression process, coating process, and characteristics of different molecules - Advanced understanding of critical formulations, MUPS Formulation Processing & Compression, Bilayer Process & Compression, Compression Machine related knowledge, FDA regulations, audits, and compliance, as well as validation and documentation Behavioral: - Demonstrate innovation, cross-functional team working, quality and service orientation, and delivering consistent results - Focus on people development for multiskilling, training for knowledge enhancement, and personal development Key Result Areas: - Effective machine testing to avoid challenges at the site - Provide effective solutions at in-house and customer sites for reported challenges - Demonstrate machine performance at the site - Ensure continuation of FDA license and compliance with related requirements,

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