311 Oot Jobs - Page 3

GLP & review of analytical data of raw material, finished product & stability sample analysis Knowledge of RCA & CAPA,Change control,Deviation,OOS,Failures,Incident,APQR,batch records,market complaint,line clearance,in-process checks & AQL procedures Required Candidate profile Must have good experience in quality assurance - cosmetics or Pharma industry Must have independently handled the QA documentation wrork Must be sincere and smart Can set new processes

• To maintain and adherence of the GLP and safety procedures in laboratory. • To perform the analysis as per work allocation and records the results in work sheet (Protocols) for raw material / packing materials/intermediates /APIs/ Stability and etc.. as per current specification and method of analysis. • To work as Analyst and maintain the CFR 21 part -11 compliance by following laid down procedures. • To perform all the HPLC related analysis and perform the online documentation for In-process, intermediate, finished products & returned goods / raw materials Hold time / Stability study / working standard analysis as per laid down specification & test procedures , SOPs, as per work allocati...

Job Description You will be responsible for overseeing quality assurance processes as a Manager - Quality Assurance (QA) at ZIM Laboratories Limited located in Nagpur. Your role will involve ensuring adherence to regulatory and compliance standards, implementing strategies to maintain product quality, reviewing and approving quality documentation, managing QA audits, supervising quality control operations, and coordinating with R&D and production teams to uphold quality benchmarks. Key Responsibilities - Oversee quality assurance processes - Ensure adherence to regulatory and compliance standards - Implement strategies to maintain product quality - Review and approve quality documentation - ...

To check documents like equipment log books, temperature & humidity records, Collect in-process and Finished sample as per Specifications and Protocol. Supervision of RM/PM Sampling and dispensing procedure. Machine Line clearance of Production Area. Area Line Clearance of Production area Checking online tablet weight variation, hardness, friability, thickness & DT Time & check informality of weight. Verification of granulation, Compression, Coating, & Packing process & also release for same. Able to fill And Check BMR. Able to Give Batch Approval, verify various Documents. Able to finalize Quality of Finished goods. DOCUMENTATION

About The Role : Job TitleTrading Enabler - VP LocationMumbai, India Role Description The candidate will be part of the Asset & Liability Management (ALM) function and responsible for reducing model risk associated with interest rate risk in the banking book (IRRBB) measurements. The team acts as an intermediary in treasury itself and between the business units and other central functions like Market Risk Management and Model Risk Management. This gives you a unique view into many exciting and important topics. Treasury Treasury at Deutsche Bank is responsible for sourcing, managing, and optimizing Deutsche Bank's financial resources and providing high-quality steering to the Bank on financi...

Responsibilities: * Conduct quality control tests using HPLC & OOS methods. * Ensure compliance with GLP, CGMP, QMS & RCA principles. * Inspect raw materials & prepare test solutions. * Implement change controls & manage OOTs. Food allowance Health insurance Provident fund Annual bonus

- Provide remote QMS support for global sites, handling OOS, OOT, deviations, incidents and change controls. - Review documentation for compliance & drive continuous improvement. - Ensure timely investigation, analysis & change control initiation. Required Candidate profile - 9+ years of QC/QA experience in regulated pharma co. - Reviewing OOS, OOT, APQR & lab incident investigations, change controls & managing deviations - Strong knowledge of USFDA, EU & Health Canada

Pangea Global Services is looking for Database Researcher to join our dynamic team and embark on a rewarding career journey. Collect, verify, and organize large datasets for research and analytics purposes. Design and manage databases ensuring data integrity, security, and accessibility. Develop automated tools for data extraction and cleansing. Collaborate with analysts to support data - driven decision - making and research insights. Disclaimer : This job description has been sourced from a public domain and may have been modified by Naukri. com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before app...

Role & responsibilities :- Handling of Deviations, OOS (Out of Specification), and OOT (Out of Trend): Investigation Execution and Reporting: Impact Assessment: Quality Risk Assessment: Perform risk assessments. Document risk levels and mitigation strategies to support decision-making and continuous improvement. Knowledge of Investigation Methodologies: Apply systematic approaches to identify root causes and contributing factors. Recommend effective CAPA based on investigation findings. Maintain awareness of current regulatory expectations (e.g., FDA, EMA, WHO) regarding investigations and data integrity.

Role & responsibilities Suggested position: Sr Manager / Manager Education: Post Graduation (Life sciences preferred) Total Exp: 15-17 Years (Biopharma is preferred) Others: Ready to support in different shifts Responsibilities: Mainly responsible to review of Harvest, Drug Substance and Drug Product analytical (Biosimilars) raw data and analytical trends Conduct Gemba walkthroughs in QC department and to ensure quality compliance. Involve in investigations (Deviations, OOS, OOT, Lab incidents) to ensure QMS compliance for QC sections Audit trails and conduct routine monitoring in QC to check effectiveness of the system implemented. Responsible for preparation and review of documents SOPs, P...

Preparation, review and approval of stability summary report. Preparation, review of freeze thaw study protocol and report Preparation, review of temperature cycle study protocol and report. Required Candidate profile To review AMV, STP, specification, worksheet of finished and raw material packaging material & To Review and implement Validation protocol for process, equipment, cleaning and Analytical Validation.

Issuance of Analytical Data Sheets and Formats. Preparation and Review of specification and standard test procedure. Review of QC Analytical Data. To ensure online documentation in laboratory as Good Documentation Practices. To attend training as per refresher training schedule. To ensure all time audit readiness in the work area. To perform any other work as and when assigned by Head of department.

1. Line clearance in dispensing, manufacturing and packing area 2. In -Process Quality Assurance activities, sampling, analysis and AQL during production. 3. To ensure stage wise completeness of BMR during production. 4. Monitoring of environmental conditions in production area. 5. Coordination with other departments for smooth running of the plant. 6. Calibration, verification and maintenance of IPQA instruments. 7. To monitor process as per technical directions. 8. To fill all IPQA sampling logs in time. 9. To ensure deviations are properly documented and CAPA implemented. 10. To withdraw samples at different stages of In-Process and finished product as well as validation samples as per TD...

Skills Required: Graduate / PG in management With a minimum of 4 7 years of experience in managing the Admin function. Must have hands on experience into Advance Excel Key Responsibilities Making MIS Reports of collated data Meticulously working on the data collated from various sources of department and preparing comprehensive reports Ensuring the precision of the reports Preparing Delivery Files Extensive work on Excel Preparing necessary dashboards for day to day operations Monitor & analyses data for business trends & prepare monthly revenue & collection report Provide cross functional quality oversight from a compliance perspective fo testing and disposition, quality investigations, val...

Responsibilities: Ensure GMP compliant operations and robust Quality Management System (QMS) execution for API manufacturing at the Ankleshwar site, including documentation control, batch release support. Batch Documentation & Release: Review BMR/BPR, analytical reports, COAs; ensure compliance with specifications and data integrity (ALCOA+). QMS Ownership: Manage change controls, deviations, CAPA, OOS/OOT investigations with timely closure and impact assessment. Documentation Control: SOPs, specifications, STPs, protocols/reports; version control and archival as per GDP. Vendor & Material Quality: Support qualification, sampling, and release of RM/PM; review COAs and ensure traceability. Tr...

Job Responsibilities To ensure Sit Ready for anytime Regulatory Inspection in Compliance to cGMP Norms of Various Regulatory Bodies. To train personnel on cGMP, regulatory expectations, and quality systems to enhance compliance and awareness. To ensure Vendor Qualification activities are conducted as per SOPs, and maintain an up-to-date Approved Vendor List and requalification of Vendor Schedule. To ensure Quality Assurance, Quality Control, Microbiology, Production, Warehouse, Engineering activities are performed in compliance as per current GMP requirement and their effective implementation. Responsible for ensuring QMS elements (Change Control, Deviations, CAPA, OOS, OOT, etc.) are implem...

Role & responsibilities Why Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients. What You Will Achieve In your role, you will help us in investigation of any quality issues in manufacturing and quality laboratories. You will work with a team to investigate deviations and out-of-specification results and atypical result investigations....

Responsible for Overall site QA compliance activities and drive the organization towards quality improvements Handling of Deviation, Change controls, OOS, OOT and CAPA including investigations and impact assessments

Review and analyze health data to ensure accuracy and compliance with regulatory requirements.Collaborate with cross-functional teams to identify and resolve data discrepancies.Develop/implement effective data review processes to improve quality Required Candidate profile Strong understanding of employment firms and recruitment services.Excellent analytical and problem-solving skills, with attention to detail and the ability to work independently.

Review and analyze health data to ensure accuracy and compliance with regulations.Identify trends and patterns in health data to inform business decisions.Collaborate with cross-functional teams to develop and implement data-driven solutions. Required Candidate profile Strong understanding of health data principles and regulations.Experience with data analysis and interpretation techniques.Excellent communication and collaboration skills.

Conduct thorough reviews of ECR data to ensure accuracy and compliance with company standards.Identify and report any discrepancies or errors in the ECR system.Collaborate with cross-functional teams to resolve issues Required Candidate profile Strong understanding of ECR systems and data analysis principles. Excellent analytical and problem-solving skills with attention to detail.

Conduct thorough reviews of ECR data to ensure accuracy and compliance with company standards.Identify and report any discrepancies or errors in the ECR system.Collaborate with cross-functional teams to resolve issues Required Candidate profile Strong understanding of ECR systems and data review principles. Excellent analytical and problem-solving skills with attention to detail. Ability to work effectively in a fast-paced environment

Responsibilities: Individually handling department & manpower. Strong leadership skills to guide, supervise work activities, and help team members develop their skills. Work allocation / Planning and Review of documents. Preparation of SOP, Specification, Standard Test Procedures (STP), Raw Data Sheet (Protocol), Excel worksheet validation etc. Preparation and review of Analytical Method Validation protocol & Report. Preparation and review of equipment qualification documents. Handling of QMS documents like Change control, Deviation, Incidents, OOS, OOT etc. To investigate, identify the root cause and troubleshoot. To maintain GLP and discipline in the QC department. Required Skills Change C...

Conduct thorough reviews of ECRF data to ensure accuracy and compliance with regulatory requirements. Identify and report any discrepancies or issues found during data review. Collaborate with cross-functional teams to resolve data-related issues. Required Candidate profile Strong understanding of ECRF data management principles and practices. Excellent analytical and problem-solving skills, with attention to detail.

Responsibilities: Ensuring Compliances: Quality Assurance professionals play an important role in ensuring that all processes & product comply with QMS/IMS and other relevant regulations. Quality Control: Quality Assurance professionals involved in the development, maintenance & implementation of procedures and system in QC and production. Documentation: QA professionals review and approve documents such as SOPs, batch record & other quality related documents. Audits & inspections: They conduct audits & inspections to ensure compliances with regulations & identify areas for improvements. Investigation & Corrective Action: They investigate deviations or non-conformance & implement corrective ...