181 Oos Jobs - Page 2

Understand customer needs & requirements to develop effective quality control processes Supervise inspectors, Technicians Keep accurate documentation Handling OOS & OOT Preparation of Audit report Understand requirements of ISO 13485:2016 (MDQMS)

Role & responsibilities BMR/BCR preparation and approval SOP preparation and approval Change control and Deviation handling OOS/OOT investigation & CAPA implementation Trackwise software and good Computer skill.

Lodha Group is looking for Data Analyst (Pre-Sales) to join our dynamic team and embark on a rewarding career journey Managing master data, including creation, updates, and deletion. Managing users and user roles. Provide quality assurance of imported data, working with quality assurance analysts if necessary. Commissioning and decommissioning of data sets. Processing confidential data and information according to guidelines. Helping develop reports and analysis. Managing and designing the reporting environment, including data sources, security, and metadata. Supporting the data warehouse in identifying and revising reporting requirements. Supporting initiatives for data integrity and normalization. Assessing tests and implementing new or upgraded software and assisting with strategic decisions on new systems. Generating reports from single or multiple systems. Troubleshooting the reporting database environment and reports. Evaluating changes and updates to source production systems. Training end-users on new reports and dashboards. Providing technical expertise in data storage structures, data mining, and data cleansing.

Oversees QC activities, staff training, SOPs, calibrations, GLP compliance, audits, records, and lab investigations (OOS/OOT) and aligns QC goals with production and ensures lab standards (candidates having approval from Raj. FDA will be preferred).

Roles and Responsibilities Conduct stability analysis of APIs using HPLC, GC, and other relevant methods. Ensure compliance with cGMP guidelines during API production. Perform method validation, transfer, and maintenance activities according to established procedures. Collaborate with cross-functional teams to resolve quality issues and implement corrective actions. Maintain accurate records of testing results, reports, and documentation. Desired Candidate Profile 8-12 years of experience in Quality Control (API) department in pharmaceutical industry. MS/M.Sc(Science) degree from a recognized university. Strong knowledge of QMS principles and regulations such as GMP/cGMP. Must experience in Team Handling of 5 Members.

Roles and Responsibilities Prepare batch manufacturing documents, including BMRs, BPRs, and BPR reviews. Ensure compliance with GMP guidelines during API production. Conduct OOS investigations and implement corrective actions as needed. Collaborate with cross-functional teams to resolve documentation-related issues. Maintain accurate records of all documentation activities. Desired Candidate Profile 3-6 years of experience in API production or related field (document preparation). Strong understanding of GMP compliance and regulations. Proficiency in document preparation software such as BPR review tools. Experience with investigation procedures for OOS events.

Role & responsibilities Leads and optimizes QA function that supports organizations QMS in compliance with respective international regulatory requirements. • Hosting and support in external/client audits and regulatory inspections hosted by Auriga. • Audits and inspection handling. • Conduct internal system and process audits within Auriga systems. • Conduct external audits including the audit of vendors, clients and/or clients business partners and service providers. • Lead and manage a team of clinical audit professionals, providing guidance, training, and mentorship. • Support the operations team for adequate root cause identification, conducting gap analysis and implementation of corrective action plan. • Participate in risk assessments and preparation of risk-based audit plan for auditing internal processes, vendors and customers. • Supporting the CAPA management in audit and Inspection related CAPAs. • Support the document life cycle management, deviation handling process and change control process. • Prepare audit reports to communicate outcomes of quality review activities. • Preparation and or/review of company standard operating procedures (SOPs) and such other quality documents. • Interpret and implement quality assurance standards within the organization. • Liaise with quality representatives, internal customers and external customers across Auriga global access offices as required to achieve quality objectives. • Ensure development and maintenance of a PV Quality System for Standard Operating Procedures, auditing, review CAPAs, Change control and deviations. • Evaluate client audit and regulatory inspection findings and prepare and distributes reports to observation staff, management and customers.

JOB SUMMARY: To ensure on handling of documents like analytical test procedures, specifications, standard operating procedures from initiation till implementation. To ensure quality control GLP related activities are performed as per SOP for calibration, qualification of instrument and equipment. To ensure sampling activities are performed as per SOP and sample integrity are maintained till analysis completion. To ensure working/reference standards are made available for analysis and timely qualification of standards within due date. To involve in investigations and to collaborate with cross function team for root cause determination and implementation of effective CAPA. To ensure safety and use of required personal protective equipments during day-to-day activities. Responsible for carrying out any other responsibilities assigned from time to time orally or in writing by HOD. To maintain and enhance quality index of the site unit data elements pertaining to QC function. Identify the training need and organize for the training to concerned group in QC to avoid event and unconfirmed OOS due to errors during analysis. ESSENTIAL JOB FUNCTIONS: To ensure stability samples are charged and analysis completed within the due date and stability chambers are monitored and maintained at respective conditions. To ensure effective analytical methodology are placed for testing. To ensure analytical method validation and analytical method transfer activities are completed and validated methods are adopted for testing. To ensure sampling activities of RM/Intermediates/Finished as per approved standard operating procedures. To ensure stability study sampling, stability study chamber monitoring and timely withdrawal and completion of analysis. To review the analytical method validation, method transfer, regulatory submission related documents, working reference standard procurements. To co-ordinate self-inspection (internal audit) and its compliances. To approve the lab event/out of specification/our of trend/our of calibration/CAPA/change control/deviation. Ensure trend of quality control errors and effective CAPA implementation. To monitor the compliance with the requirement of GMP. To participate in the management reviews of process performances, product quality and of the quality management systems and advocating continual improvement. To ensure a timely and effective communication and escalation process exists to raise quality issues to appropriate levels of management. To conduct training program and ensure it effectiveness. To ensure quality control GLP related activities are performed as per SOP for calibration, qualification of instrument and equipment. To follow safety & use of required personal protective equipment during day to day activities. To ensure maintenance of housekeeping at shop floor and reporting day to day activities to QC head and in absence delegate change to second line manager. To participate in laboratory internal audits, customer audits, health authority inspection. Awareness of IMS systems (ISO14001:2015 and ISO45001:2018) Travel Estimate Low Job Requirements Educational Qualification M.Sc Chemistry Experience 15+ years experience

1)Compliance and Documentation Management 2) Quality Control Performance Metrics 3)Stability study & Documentation Oversight 4)Quality Management System (QMS) Management 5 to 10 years of relevant experience Should be familiar with cGMP practices.

1. Monitoringof Site Activities 2. FindingUnsafe Acts Unsafe conditions and escalating the same to plant HSE leadclearing the same on shop floor by the deviated departments. 3. Supportingto plant HSE Lead in the HSE functions/ activities/ procedures in relateddocumentations as per the department requirements. 4. Ensuringto impart the Tool Box Talks to workmen or conducting by the supervisors priorto the work activities. 5. Updatingthe HSE documentation on regular basis. 6. Ensuringthe contractors workmen to follow the HSE policies procedures as per theHetero Plasma Sciences Pvt Ltd. 7. Monitoringthe vendors/ contractors at site during execution of works and their sitevisits. 8. Regularsite inspections/ site rounds. 9. Ensuringto monitor the activities whether they (Hetero team/ contractor workmen) areadhering to work permits or not and raising the deviation as per the violation. 10. Planningdoing the HSE activities at site as per the HSE planner by coordinatingwith cross functional departments. 11. Periodicchecking inspection of Safety Emergency equipments and clearing its gapsif there will any by the support of concerned departments.

1. Preparation of buffers and other solutions for plasma fractionation process. 2. Batch manufacturing record samples sending to QC for analysis. 3. Performing PHT, CIP and SIP of all the process vessels. 4.Follow shift schedule and production schedule, planning of shifts for the subordinate as per process requirement. 5. Preparation Review of equipment IQ, OQ and PQ documents. 6.To involve in Production planning and execution. 7. To get involved in technical discussion and planning for execution of new product validation batches and commercial batches in plant. 8. To get involved in Batch-to-batch yield analysis and investigation for low yield or OOS routed through Change control or deviation.

Shall have good knowledge on operation of Purified water system. 2. Shall have good knowledge on operation of Pure steam generator system. 3. Shall have good knowledge on operation of WFI system. 4. Shall have good knowledge on GMP and GDP.

1. Shall have good knowledge on operation of Purified water system. 2. Shall have good knowledge on operation of Pure steam generator system. 3. Shall have good knowledge on operation of WFI system. 4. Shall have good knowledge on GMP and GDP.

1. Shall have good knowledge on operation of Purified water system. 2. Shall have good knowledge on operation of Pure steam generator system. 3. Shall have good knowledge on operation of WFI system. 4. Shall have good knowledge on GMP and GDP.

1. Responsible for review of specifications, STPs, GTPs and analytical test data sheets. 2. Review of analytical reports of raw material, packing materials, water samples, product samples, OOT, water trends and ensuring compliance. 3. Responsible to attend the training programs. 4. Responsible for monitoring of quality control Lab (Daily calibration, PMP, Instruments back up data, Excel work sheets lock, user log books). 6. Responsible for handling technology transfer documents. 7. Responsible for review of stability protocols, stability analytical data and summary reports. 8. Responsible for handling of change controls, OOS, OOT, Incidents and investigations. 9. Responsible for compliance of GLP in Lab. 10. Responsible for review and approval of LIMS related activities. 11. Approval and issuance of configured COA in LIMS. 12. Responsible for audit trail verification for QC lab instruments.

1. Preparation and Maintenance of SOPs, STPs, Specifications, GTPs and Worksheets related to Product testing. 2. Preparation, revision, review and execution of Analytical method Validation protocols and reports related to product testing. 3. Responsibilities for preparation of masters (Product, Specifications, Tests, worksheets, Test plans and TTD etc.) in LIMS. 4. Responsibilities for effective documents (STPs, Specifications and GTPs etc.) uploaded in LDMS. 5. Responsible for material management like weekly, monthly indent Ensure monthly indents are placed and materials received in timely manner, reservation placed through SAP. Ensure compliance `w.r.t expiry, usage and discard of materials. 6. Operation and calibration of QC Instruments related to product testing. 7. Testing and release of product samples by techniques such as: General tests (Physical appearance, pH, Color, Extractable volume, Osmolality, Conductivity, etc.) Gel Electrophoresis (IEF, SDS-PAGE, etc.) Colorimetric assays (Sialic acid, Quantification of Polysorbate 80 and Polysorbate-20, etc.) Quantification assays (Protein concentration by absorbance (Spectral scan)/Protein content by UV (OD @ 280 nm, Trehalose dihydrate, Mannitol, Sucrose, etc.) ELISAs (Host Cell derived Proteins, Protein A Leachate, etc.) Q-PCR (Host Cell DNA, Mycoplasma testing etc.) HPLC techniques (Product concentration by RP-HPLC, Size Exclusion chromatography, Peptide mapping, etc.) UPLC techniques (Cation exchange chromatography, Protein A Chromatography, N-Linked Glycans by hydrophilic liquid interaction chromatography, etc.) 8. Preparation of reagent solutions, buffers and maintenance of the records. 9. Temperature and humidity monitoring of labs and instruments. 10. Sample receiving, A.R. No allotment, Testing, Documentation and reporting of analytical results in LIMS for In process, batch release, stability and Miscellaneous samples related to product testing. 11. Withdrawal and aliquoting of batch release and stability samples for analysis. 12. Responsible for preparation of shift schedules and test planning activities. 13. Responsible for cGLP compliance. 14. Responsible for handling of OOT (Out Of Trend), OOS (Out Of Specification), Incidents, LIRs and Change controls related to product testing. 15. Responsible for change management: Ensure CRNs initiation and closure within target date. 16. Preparation, revision and review of miscellaneous protocols and reports related to product testing. 17. Review of analytical data and work sheets related to product testing. 18. Maintenance of stability samples and reserve samples related to product testing. 19. Responsible to execute the assigned activities in LIMS, TRIMS, DMS or any other software applications. 20. Responsible for usage, monitoring and verification of all kind of laboratory books. 21. Preparation, execution and review of reference standard qualification. 22. Maintenance of all QC documents related to product testing. 23. Assist in execution of Analytical method validations.

1. Responsible for preparation of Validation Master Plan, validation related SOPs and schedules. 2. Responsible for preparation of facility, equipment, area qualification protocols and reports. 3. Responsible for execution of facility, equipment and area qualification activities. 4. Responsible for operation and handling of Dataloggers, HVAC related equipments. 5. Responsible for compilation and review of validation raw data and test certificates. 6. Responsible for preparation of Installation qualification (IQ), Operational qualification (OQ) and Performance qualification (PQ), revalidation protocols and reports. 7. Responsible for execution of IQ, OQ, PQ, Revalidation of Equipments. 8. Responsible for In-process assurance of Engineering department activities like utilities monitoring, verification of log books, PMP records, review of Schedules and calibration records. 9. Responsible for co-ordination with user department and validation service providers for execution of qualification activities. 10. Responsible for handling of risk assessments, deviation, change control and incidents related to qualification/validation. 11. Responsible for preparation of Utilities Annual summary reports.

1. To perform Equipment operation and cleaning. 2. To supervise the Visual inspection and batch packing execution as per plan. 3. To perform the documentation as per Batch record and SOP. 4. To perform the equipment qualification as per protocols and SOP. 5. Responsible to maintain documents as per cGMP norms. 6. Co-ordinate to cross functional team as per day-to-day activities. 7. Responsible for SOP, MPR and BPR preparation and revision. 8. Co-ordination with team to execute daily packing and visual inspection plan. 9. Ensure the training completion before doing activity. 10. To raise batch record request as per plan. 11. Responsible for QMS related activity(Change control, Deviations, Batch record) in packing and visual inspection activity. 12. Monitor day to day activities. 13. Reporting all the activities, incidents and problems to Reporting officer

1. Responsible for review of specifications, STPs, GTPs and analytical test data sheets. 2. Review of analytical reports of raw material, packing materials, water samples, product samples, OOT, water trends and ensuring compliance. 3. Responsible to attend the training programs. 4. Responsible for monitoring of quality control Lab (Daily calibration, PMP, Instruments back up data, Excel work sheets lock, user log books). 6. Responsible for handling technology transfer documents. 7. Responsible for review of stability protocols, stability analytical data and summary reports. 8. Responsible for handling of change controls, OOS, OOT, Incidents and investigations. 9. Responsible for compliance of GLP in Lab. 10. Responsible for review and approval of LIMS related activities. 11. Approval and issuance of configured COA in LIMS. 12. Responsible for audit trail verification for QC lab instruments.

We are looking for a skilled MySQL DBA Professional with 5-10 years of experience to join our team in IDESLABS PRIVATE LIMITED. The ideal candidate will have a strong background in database administration and management. Roles and Responsibility Design, implement, and manage database architectures to support business requirements. Develop and maintain databases to ensure high performance, security, and availability. Collaborate with cross-functional teams to identify and prioritize database needs. Troubleshoot and resolve complex database issues efficiently. Ensure compliance with organizational standards and best practices. Optimize database queries for improved performance and efficiency. Job Requirements Strong knowledge of MySQL database administration and management. Experience with database design, development, and implementation. Excellent problem-solving skills and attention to detail. Ability to work collaboratively in a team environment. Strong communication and interpersonal skills. Familiarity with database security and access control measures. Proficiency in managing large-scale databases and ensuring data integrity.

We are currently hiring a candidate who will be responsible for managing ecom platforms to ensure achievement of annual targets in terms of revenue and growing market share. Category Management Identifying opportunities and charting growth within and outside of operating categories aggressively New platform development Set up and drive sales on new ecom marketplaces to capture market share in relevant categories Account management Liaising with marketplace managers, solving account issues, building relationships, aligning internal teams for success Management on ecommerce platforms Studying & analyzing competition, own products, keywords etc. to provide deep insights and inputs on observations and drive interventions to completion to achieve goals Product launches Planning and executing successful launch campaigns, monitoring, linking up with internal and external teams to drive success Inventory planning Ensuring inventory replenishment to avoid OOS, ensuring fastest time to customer by planning All India inventory disposition Deals, Promotions and Ads Management of all marketing including deals, promos and ads, strategizing and executing, monitoring results for optimization Reporting & Analysis Monitoring all ecom metrics, generating informational dashboards to aid decision making, analysing data to drive interventions

RoleKMIL - Monitoring Requirement2 Gender- Male/ Female both are preferred Education Background- CA / MBA (preference would be MBA- Finance) Experience level - 3 to 5 years (relevant experience not required) Preferred profile- Risk team of retail or wholesale division of any Bank / NBFC. The Key profile of Monitoring & Policy Risk Analyst is to carry out Risk Assessments for Pan India CRE Lending Portfolio is laid down below for your reference . Key responsibilities include Implement effective risk management processes for the Construction Finance business verticals to identify potential risk in the underwritten portfolio and ensure portfolio health Carry out background research and gain a thorough understanding on the project, the developer and the regional market, highlighting any negative reports so as to ensure the quality of the invested portfolio. Track the progress of the project and monitor disbursement as per the project lifecycle. Ensure that the disbursement milestones are achieved as per the underwritten sanctioned conditions. Recommend policy amendments/ refinements based on regulatory and market changes Undertake automation of existing processes by liaising with the IT department Prepare various dashboards and reports such as Monthly and quarterly portfolio monitoring report Overdue Analysis Early Warning Signals r eview Deviation Analysis Analytical Insights like Limit/ Renewal Management, Covenant/ PDD Management Trends analysis of the regional P ortfolio Perform various monitoring activities such as NOC issuance- Due diligence for the Monitoring and instruct for Escrow SI Threshold Map collections with the Escrow credits on regular intervals.

Job Title:- KMIL- Wholesale Banking- Risk Monitoring Analyst Grade:- M4/M5 Location:- Mumbai Track financial and project performance covenant: Monitoring financial and project performance against predefined convenants. Identify deviations and promptly communicate findings to relevant stakeholders. Project performance analysis: Conduct through analysis of project performance metrics. Provide insights and recommendations to mitigate risks. Track Compliances to sanctions conditions: Moniotor compliance with sanctions conditions imposed on credit facilities. Take proactive measures to address any non- compliance issue Site Visit: Conduct on site visit to assess the progress and status of projects. Documents observations and report findings to management Compliance with RERA regulations: Ensure adherence to regulatory guidelines and internal policies. Stay updated on regulatory changes and implement necessary adjustments. Early warning signal tracking: Identify early warning signal as per the existing policy indicating potential credit risks. Collaborate with relevant teams to develop strategies for risk mitigation. Coordination with business and credit underwriting team Liaise with business units and credit underwriting teams to gather relevant data and insights. Collaborate on credit risk assessment and monitoring activities. Job Requirement- MBA with 5 to 8 Years of experience is preferred

You will be responsible for initiating, reviewing, and approving various quality management systems such as Change Controls, Deviations, Investigations, CAPA, OOS, and Complaints. You will also handle Return Goods and ensure the smooth functioning of the quality system by performing risk assessments as required. Conducting regular internal audits and reviewing/approving all documents including SOPs, Spec & STPs, Forms, protocols, and reports will be part of your duties. Additionally, you will review annual product quality review reports, provide training on cGMP topics to employees, and support customer audits/visits as well as regulatory audits. You will assist in providing necessary documents for amendments, annual updates, regulatory filings, and CMC supporting documentation. Other tasks may include filling out questionnaires, declarations, quality agreements, and executing any additional responsibilities assigned by the Head of Department.,

Greetings from Avani Consulting. We are hiring QC Officer / Trainee and QC Associates for a leading Pharma API Company in Mysore. Positions: 1. QC Officer / Trainee : EXP: 2 to 3 year exp in Pharma Company. Salary : Up to 4LPA ( Take way home only . NO Parks & Benefits ) 2. Quality Control Associates - API : EXP: 5 to 9 year exp in Pharma API Industry. Salary : Up to 7.5LPA ( Including Parks & Benefits ) Preferred candidate profile Qualification : M.Sc. Chemistry Experience : Pharma -API Quality Control Role & responsibilities : Handling and troubleshooting of Analytical Equipment's like HPLC, GC-HS, FT-IR, UV, Potentiometry, Polarimeter, ICP and KF. Handling of Analytical Method development and Method Validations. Qualification of Equipments as per GLP requirements. Analysis of Inprocess, Stability and FG Samples as per the Specification. Operation, Maintenance and Calibration of HPLC and GC as per the schedule. Review of results and release of Analytical test report or Certificate of Analysis. Maintenance of minimum consumables in the Laboratory. Planning and coordination to release on time results delivery. Investigation of OOT/OOS in the laboratory. Sampling of Raw Material, Inprocess and Finished product samples. Basic knowledge on LIMS/SAP. Handling 21 CFR compliance. ***NOTE :: NO CHARGES Looking forward to know about your interest. Thanks & Regards Priyanka Palit [9518220852 | priyanka@avaniconsulting.com]