7 Deviation Handling Jobs

The ideal candidate will be responsible for overseeing the execution of production plans by utilizing pre-approved procedures, protocols, and manufacturing records. You will need to ensure strict adherence to cGMP and EHS (Environmental, Health, and Safety) norms to maintain compliance. Additionally, you will supervise and coordinate production activities, managing available resources effectively to meet production targets. Maintaining quality control is a key aspect of this role, where you will be required to uphold standard process parameters following Batch Manufacturing Records (BMRs) and other relevant documents to ensure high-quality production and compliance. Furthermore, you will be responsible for preparing and managing documentation, including Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs). It will be your duty to enforce and sustain cGMP practices in the plant, overseeing activities such as raw material dispensing, weighing balance calibration, and cleaning procedures. Moreover, you will initiate and oversee change control procedures and provide training to production personnel on cGMP trends, regulatory requirements, and standard operating procedures (SOPs). In this role, you will be accountable for maintaining an optimal level of manpower and overseeing manpower development to enhance quality, productivity, and cost efficiency. Handling deviations, change control, and investigation reports will also fall under your responsibilities. This is a full-time, permanent position that offers benefits such as health insurance, paid sick time, and Provident Fund. The work schedule is during day shifts, and the work location is on-site.,

Review and approval of all analytical test data of Quality control. Review and usage decision of analytical reports in LIMS, Empower and SAP. Electronic signatures level-2 for chromatography data station (CDS) and standalone instruments. Review the Analytical test report in LIMS. Review the reported results against specification and trends. Review the method validation and method transfer documents. Review the instrument calibrations and working standard qualification records. Handling the Incidents/ Deviations, Out of Trends, Out of Specification including investigations, Corrective and Preventive actions follow up and closure. Monitoring of analytical activities in Quality control laboratory. Verification of Specifications/standard test Procedures/Worksheets/Analytical Reports before Approval. Verification and review of the audit trails for Standalone, Empower and LIMS. Ensure cGMP / cGLP compliance. To follow Safety, Health and Environmental procedures and practices. Review and approval of excel sheet validations. Review results acceptance for API and Excipients and Packing material. Review of compiled of Stability Data and its verification/ Exhibit batch sampling protocols. Handling of Robotic Process Automation of Chromatography Data review (RPACD) To carry any other activities assigned by upward reporting staff. Qualifications Educational qualification: A Bachelor's/Master's degree in Pharmacy, Chemistry, Chemical Engineering, or a related field Minimum work experience : 3 to 7 years of experience in pharmaceutical manufacturing or a similar role

As an HVAC & Portable Water System Technician, you will be responsible for ensuring the healthy operation of HVAC equipment with minimal breakdowns. This includes conducting maintenance operations and troubleshooting of electrical panels, as well as managing the portable water system throughout the entire plant. You will also be required to validate the HVAC system regularly to ensure the healthiness of the AHU system. Additionally, you will be responsible for in-house installation work related to the HVAC system, maintaining log keeping in compliance with QMS standards, executing breakdowns, maintenance, and troubleshooting of the HVAC system, and managing inventory control to prevent equipment downtime. Safety concerns should be a top priority to avoid accidents during work, and providing training to junior staff for better job performance is essential. In terms of new projects, you will be involved in planning changes in facility, executing the changes, validating and qualifying them, and eventually handing them over to the end users. It will also be your responsibility to supervise the preparation of QMS documents for HVAC validation, including SOPs, protocols, reports, and ensuring compliance with current guidelines. Handling deviation and change control related documents will also fall under your purview. You will be involved in vendor selection and qualification for validation activities, as well as planning and executing HVAC validations according to predefined SOP protocols. Effective inventory management for critical spare parts to reduce equipment downtime will also be a key aspect of your role.,

The responsibilities for this role include reviewing raw and finished product specifications, ensuring good laboratory practices in the Quality Control department, reviewing audit trial records, analyzing analytical records, reviewing instrument calibration and equipment qualification documents related to QC, validating analytical methods, verifying samples, handling reserve sample room, ensuring analyst qualification, reviewing working standards, managing deviations, change control, OOT, OOS, laboratory incidents, investigations, and annual trends, coordinating CAPA implementation verification and closure, reviewing instrument and equipment preventive maintenance, monitoring and recording temperature and humidity in the laboratory area, and managing document control. The ideal candidate should possess skills in audit trial, OOT, deviation handling, OOS, backup and restoration data management, sample handling, instrument maintenance, quality assurance, instrument calibration, laboratory practice, laboratory incidents management, change control, method edit forms, working standards review, analytical records analysis, quality control, document management, equipment qualification, stability protocols, analyst qualification, analytical method validation, CAPA implementation, and temperature monitoring.,

As a bench scientist in our organization, you will be responsible for conducting experimentation and research in the area of formulation development, process development, regulatory affairs, and intellectual property for global markets. Your work will involve planning and executing experiments aligned with project milestones while applying scientific principles such as Quality by Design (QbD), Design of Experiments (DoE), statistics, and scale-up principles. You will be expected to analyze and interpret data from literature reviews effectively to support decision-making processes. Additionally, you will need to understand the intellectual property landscape, develop strategies, search for prior art, and establish proof of concept through experimentation. Collaboration with cross-functional teams including Manufacturing Science and Technology (MS&T), Quality Assurance (QA), Quality Control (QC), and production teams across different geographies will be crucial for technology transfer and timely execution of submission batches. Your role will also involve identifying challenges, bottlenecks in development, and providing mitigation proposals at various stages of product development. Furthermore, you will be responsible for problem-solving, prioritizing activities, conducting development trials, and ensuring alignment with established milestones. Clear communication with internal stakeholders, proactive identification of challenges or risks, and adherence to business unit Key Performance Indicators (KPIs) will be essential aspects of your role. On a day-to-day basis, you will work closely with the formulation development teams to achieve key milestones, conduct experiments following QbD principles, and prepare presentations at different stages of product development. Your tasks will include literature reviews, sourcing API and Excipients, conducting preformulation studies, executing development trials, interpreting analytical data, and preparing necessary documentation for regulatory submissions. To be successful in this role, you should hold a Ph.D. in Pharmaceutical Sciences with at least 1 year of experience or an M.Pharm in Pharmaceutical Sciences with a minimum of 3 years of experience from reputable universities. Prior experience in working with generic pharmaceuticals in regulated markets such as the US, EU, or Canada will be advantageous. Your commitment to personal accountability, effective work habits, continuous learning, and collaboration with internal teams will be instrumental in contributing to the success of our organization's mission to make good health more affordable and accessible globally.,

Perform inspections on products, components and materials to ensure they meet specified quality standards and customer requirements (Incoming Quality , in process Quality & Final Inspection). Monitoring of Product and Process related documents and Improvements activities. Basic Prepare document for customer and supplier regarding Quality system audit. Customer Complaint Handling, Rework and Rejection, in process Rejection Control. Ensure Collection, Monitoring & highlight (Corrective Action preventive action (CAPA),Customer Compliant, deviation handling etc. Communicate quality concerns and findings to relevant to production managers, engineers. Participate in continuous improvement initiatives to improve product quality and reduce Defects. Basic Knowledge of ISO 9001:2015 Related documentation, implementation and maintain. Basic skill of Microsoft Office like Excel, word and Power point. Team HR Prateek Rana 9662590791 prateek@srisaioverseas.com,

Manage QA documents and records Handle deviations, changes, CAPA, complaints Conduct audits and supplier evaluations Monitor quality metrics and improvements Train staff and ensure ISO compliance