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2 Capa Replication Jobs

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4.0 - 8.0 years

0 Lacs

gujarat

On-site

As a member of the ACG Corporate team, your primary responsibilities will include preparing and conducting tests such as MLT and Water analysis in the Micro Lab. It is crucial to ensure proper documentation and to develop and establish testing procedures. Maintaining accurate records, keeping the work space organized, and fostering a quality culture across the plant are essential aspects of this role. Additionally, you will be responsible for establishing a review mechanism to continuously upgrade and standardize processes. In the functional core of your role, you will be required to review customer quality complaints, which involves investigating complaints, conducting root cause analysis, and identifying Corrective and Preventive Actions (CAPA). It is important to ensure timely closure of complaints within defined timelines and to implement CAPA effectively. Sustainability of the Quality Management System (QMS) through managing deviations, change control, Out-of-Specification (OOS) results, and incident reporting with Quality Risk Management (QRM) is a key aspect of this position. You will also be accountable for timely batch release, maintaining customer-specific certifications for the plant, and independently handling customer audits while providing support to the team during audits. Key result areas for this role include reducing customer complaints, enhancing the complaint resolution score in surveys, minimizing internal failures (in collaboration with the Plant Head), ensuring reproducibility of test results, timely completion of facility licenses and certifications, and effective replication of CAPA for customer/internal audits and Annual Product Quality Review (APQR). In terms of key interfaces, you will interact with internal stakeholders such as Operations, Technical Services, and Quality & Regulatory Affairs/Quality Assurance (Q&RA/QA). Externally, you will engage with customers, external agencies/vendors, and regulatory bodies like the FDA.,

Posted 12 hours ago

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3.0 - 7.0 years

0 Lacs

gujarat

On-site

As a member of the ACG Corporate team, your primary responsibilities will include preparing and conducting tests such as MLT and Water analysis in the Micro Lab. It is crucial to ensure proper documentation, develop and establish testing procedures, maintain accurate records, and uphold a clean work space. Your role will also involve fostering a culture of quality across the plant and implementing a review mechanism to consistently enhance and standardize processes. Within the functional core of your responsibilities, you will be expected to review customer quality complaints, conduct complaint investigations, perform root cause analysis, and identify Corrective and Preventive Actions (CAPA). You will need to ensure timely closure of complaints with the implementation of CAPA, maintain the Quality Management System (QMS) covering deviations, change control, Out-of-Specification (OOS) results, and incident reporting with Quality Risk Management (QRM) principles. Timely batch release, availability of customer-specific certifications, handling customer audits independently, and supporting the team during audits are also key aspects of the role. Your key result areas will focus on reducing customer complaints, enhancing the resolution score in surveys, minimizing internal failures in collaboration with the Plant Head, ensuring the reproducibility of test results, and achieving timely completion of facility licenses and certifications. Furthermore, you will be responsible for the timely and effective replication of CAPA for customer/internal audits and Annual Product Quality Review (APQR). In this role, you will interact with various internal interfaces such as Operations, Technical Services, and Quality & Regulatory Affairs/Quality Assurance (Q&RA/QA). Externally, you will engage with customers, external agencies/vendors, and regulatory bodies like the FDA. Your ability to effectively collaborate with these key interfaces will be essential in driving quality and compliance within the organization.,

Posted 1 day ago

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