07 Oct
|
Synovatic India Machinery
|
Umargam
07 Oct
Synovatic India Machinery
Umargam
Company Description Synovatic India Machinery Pvt. Ltd.™ is a leading manufacturer and supplier of machinery and equipment for industries such as Pharmaceuticals, Chemicals, APIs, and more.
Role DescriptionThe QA/QC Executive Engineer is a full-time, on-site position based in Umbergaon, responsible for overseeing and ensuring quality assurance and quality control activities across manufacturing processes. The role involves ensuring that products, components, manufacturing processes, and documentation comply with customer requirements, approved specifications, drawings, and applicable quality standards.
The candidate will be responsible for preparation and review of Qualification Documents such as DQ, IQ, and OQ, along with FAT (Factory Acceptance Test) documentation and Compliance Reports. The role requires strong hands-on experience in quality documentation, inspection, testing, and coordination with customers and internal teams for successful completion of FAT activities.
Key responsibilities include
- Preparation, review, and compilation of Qualification Documents including DQ, IQ, and OQ as per project and customer requirements.
- Preparation of FAT protocols, FAT reports, Compliance Reports, test plans, inspection reports, and other quality-related documentation.
- Strong involvement in FAT planning and execution, including coordination with internal departments and customers.
- Taking responsibility for conducting and coordinating External FATs, including customer inspections, addressing technical/quality observations, and ensuring timely closure of punch points.
- Conducting Inward Material Inspection (Incoming Quality Inspection) of raw materials, bought-out components, fabricated parts, and other incoming materials against drawings, specifications, purchase requirements, and quality standards.
- Maintaining proper records of inward inspection,
inspection reports, material certificates, test certificates, and related quality documentation.
- Monitoring manufacturing and assembly activities to ensure compliance with approved drawings, specifications, quality standards, and customer requirements.
- Conducting stage-wise and final inspections of machinery, components, and assemblies.
- Reviewing technical specifications, engineering drawings, quality requirements, and inspection criteria.
- Identifying and reporting non-conformities and coordinating with Production, Design, Purchase, and other relevant departments for corrective actions.
- Supporting Root Cause Analysis, CAPA, and continuous improvement activities for quality-related issues.
- Conducting and supporting internal and external quality audits and ensuring timely closure of audit observations.
- Ensuring proper maintenance, traceability, and control of quality records and documentation.
- Coordinating with suppliers for quality issues, inspection requirements, documentation, and corrective actions.
- Ensuring adherence to ISO 9001:2015, internal quality procedures, customer-specific requirements, and applicable industry standards.
- Supporting timely completion and delivery of projects by ensuring quality activities, inspections, testing, and documentation are completed within the required schedule.
- Collaborating effectively with Production, Design, Purchase, Service, and Project teams to ensure consistent product quality.
Qualifications
- Diploma/Degree in Mechanical, Production, Industrial Engineering, or a related engineering discipline.
- Relevant experience in QA/QC, quality inspection, machinery manufacturing, fabrication, industrial equipment, or similar manufacturing environments.
- Strong knowledge of Pharma & API machines, equipment, manufacturing processes, and customer-specific quality and qualification requirements.
- Strong practical knowledge and experience in DQ, IQ, OQ, and other Qualification Document preparation and execution.
- Strong experience in FAT preparation, FAT execution, FAT reporting, Compliance Reports, and customer inspection activities.
- Experience and confidence in conducting and coordinating External FATs with customers.
- Strong knowledge and hands-on experience in Inward Material Inspection / Incoming Quality Inspection.
- Positive understanding of technical drawings, specifications, BOMs, inspection standards, and quality requirements.
- Knowledge of ISO 9001:2015, quality management systems, CAPA, Root Cause Analysis, NCR management, and other quality tools.
- Experience in conducting stage-wise, in-process, final, and pre-dispatch inspections.
- Ability to prepare and maintain quality documentation, inspection reports, test reports, FAT reports, compliance reports, and qualification documents with a high level of accuracy.
- Strong analytical, problem-solving, coordination, and communication skills.
- Proficiency in MS Office (Word, Excel, PowerPoint) and relevant quality/documentation software.
- Ability to coordinate independently with customers, suppliers, Production, Design, Purchase, Service, and Project teams.
- Solid attention to detail, ownership, and ability to manage multiple quality activities and deadlines in a fast-paced manufacturing environment.
📌 QA/QC Executive Engineer (Umargam)
🏢 Synovatic India Machinery
📍 Umargam