8 Csv Validation Jobs

Job Title: Quality Assurance (QA) Team Lead QA Systems & Tools Management (QMS). Role detailed classification QA Team Lead - Systems & Tools Management (QMS) Job Summary: We are seeking highly skilled and experienced Life Sciences (LS) Quality Assurance (QA) Team Lead (TL) Systems & Tools Management (QMS) to join our LS Practice team. The QA Team Lead oversees quality systems, documentation control, and QMS operations to ensure compliance with regulatory standards (GMP, ISO, ICH). This leadership role drives continuous improvement, audit readiness, and cross-functional collaboration across manufacturing, regulatory, and quality teams. The QA TL supports the development, implementation, and m...

Title: Asst. Manager- Instrumentation & Control Custom Field 2: 1121 Location: Bavla, Gujarat, IN Country/Region: IN State: Guja City: Bavla Company: Dishman Carbogen Amcis Limited Business Unit: General Travel Description: Key Skills RequiredArea of expertise: Calibration Documentation Review, Thermal Validation, PLC and CSV Validation, QMS , Change Control, Deviation , CAPA. Experience in the field of Automation (PLC programming/SCADA). Knowledge of different types of network protocols like BACNet, LON, Modbus, OPC, and other protocols. MP documentation, guideline, documentation flow, Impact assessment , QMS, thermal validation/area temp mapping, Green/brown field project erection/commissi...

QA Team Lead 843 Job Summary We are seeking a highly skilled and experienced Life Sciences Quality Assurance (QA) Team Lead Systems & Tools Management (QMS) to join our Life Sciences Practice. This role involves leading QA teams, managing Quality Management Systems (QMS), and ensuring compliance with global regulatory standards such as GMP, ISO, ICH, cGMP, and GLP . The QA Team Lead will oversee QMS components, documentation control processes, audit readiness, and continuous improvement initiatives. The position requires strong expertise in QA systems, regulatory guidelines, and cross-functional collaboration across manufacturing, regulatory, and quality functions. Key Responsibilities Team ...

Role & responsibilities 1. Preparation of Basic & Detailed Engineering for Instrumentation and PLC /DCS related Automation Projects. 2. Review and approve the Design Documents including Specifications, Drawings, and Calculations for Instrumentation and Control System. 3. Planning, Installation, Pr-Commissioning, Commissioning and Qualification of Instrumentation and PLC /DCS related Automation Projects. 4. Involving in all CSV Validation as part of Instrumentation Scope 6. Ensure that projects are finished on schedule and under budget by working together with project managers, other engineers, and clients 7. Knowledge of Codes, Standards & Regulations related to Instrumentation and Control S...

Experience - 17 20 Years Qualification - B.E. / B. Tech Electronics / Instrumentation/Mechanical Responsibilities Manage and lead the engineering department at the site, ensuring smooth operations. Oversee operation and maintenance of HVAC systems and utilities. Develop, implement, and monitor monthly planners and maintenance schedules. Ensure readiness of the department for customer and regulatory audits; represent the department during audits. Implement corrective and preventive actions (CAPA) and monitor their effectiveness. Monitor and ensure compliance with process equipment and facility maintenance activities in line with cGMP requirements. Maintain and control all engineering document...

Senior Manager - Validation and Change Lead What you will do In this vital role you will for leading and charting the course for Applied AI & Automation technology products and services team. Our team builds and transforms technology capabilities that positively impacts business outcomes. This individual will be responsible for developing and leading a highly talented team that is built for delivering high-end and innovative technologies. The ideal candidate will have a proven track record of leadership in project management, Intelligent Automation, GxP Validation, Automated Testing, and Agile methodologies. Additionally, collaboration with Cross-Functional and global teams is required to en...

Role & responsibilities 1. Responsible for issuance and retrieval of batch production & control record (BPCR) through EDMS 2. Review of batch production & control record (BPCR) 3. To perform incubation, withdrawal and reconciliation activity of stability 4. To ensure & execute retention samples are handled as per the SOP 5. To maintain records of daily monitoring temperature & humidity of stability chamber. 6. To perform annual product quality review. 7. To perform CSV validation as per SOP 8. Applying approved labels to all approved finished products. Preferred candidate profile Bulk drug & API Industry candidate preferred.

Roles and Responsibilities Conduct CSV activities such as risk assessment, gap analysis, and validation planning. Perform computer system validation (CSV) activities according to industry standards like GAMP5 and 21 CFR Part 11. Ensure compliance with EU Annexure 11 requirements for software validation. Collaborate with cross-functional teams to identify and resolve issues related to HPLC, LIMS, EMS, BMS systems. Develop test scripts and execute tests using V-model approach. Preparation, Execution, Compilation and approval of below documents (Not limited to) 1) User requirement specifications 2) Validation Plan 3) GxP Assessment 4) System Design Specification 5) Risk Assessment 6) Network (I...