515 Ipqa Jobs - Page 5

1. Following GMP, safety practices in production facilities and work place. 2. Responsible for buffer preparation activities Area drains cleaning and documents updation. Verification and receiving of material required for buffer preparation activities. Execution of Buffer preparation activities. Preparation of area, equipments before batch activities. Updation of batch parameters. Samples handling (Sampling and labelling). Intimation of incidents to Shift in-charge. Updation of room / equipment status labels. Arrangement of sterile material. 3. Handling of documents Updation of log books. Updation of BMRs and protocols/reports 4. Responsible for operation of following production equipments Mixing systems Conductivity meter Weighing balance Peristaltic pumps Walk in Cold room Freezer room Magnetic Stirrer pH meter Heat exchanger 5. Attending training on SOP's / GMP as per schedule

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.

Responsible for production activities 1. Monitoring of area drains cleaning and documents updation. Updation of room / equipment status labels. Verification of material required for production activities. Preparation of area, equipments before batch activities. Execution of production activities. Monitoring of batch parameters. Updation of batch parameters. Samples handling (Sampling and labelling). Intimation of incidents to Shift in-charge. Assisting in column packing, unpacking and evaluation activity. 2. Chromatography column and resin monitoring. 3. Handling of documents Checking practical feasibility of new / revised SOPs, protocols. Updation of log books. Updation of BMRs and attaching annexures online. 4. Responsible for operation of following production equipments (but not limited to): AKTA Process Purification system Conductivity meter AKTA Pilot Purification system Peristaltic pumps TFF System Mixing Systems LAFU Filter integrity tester pH meter Heat exchanger Walk in cold room Freezer room 5. Training: Attending training on SOP's / GMP as per schedule. 6. Responsible for Quality Management Systems Initiation of breakdown request. Initiation of CRN's. Initiation of incidents, Investigations and CAPA.Please enter job description

1. Following GMP, safety practices in production facilities and work place. 2. Responsible for production activities: Monitoring of area drains cleaning and documents updation. Updation of area / equipment status labels. Samples handling (Sampling and labelling). Arrangement of material required for activities. Assisting in Execution of production activities. Updation of BMR's. Receiving material (RM miscellaneous). Returning miscellaneous materials to warehouse. Planning and Execution of FDS thawing and dispensing activities. Assisting in product changeover activities before batch execution. Assisting column packing and execution of equipment specific protocols. Assisting in Equipment (Purification TFF system) cleaning.

Responsibilities: * Ensure compliance with GMP, GLP & BPR review. * Conduct process validation, cleaning verification & change control. * Collaborate on batch manufacturing & release processes. * Prepare SOPs, BMRs & BPRs.

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.

Responsibilities: * Ensure compliance with BMR & GMP guidelines. * Collaborate with production team on quality control processes. * Conduct IPQA activities within miscellaneous industry. Food allowance Annual bonus Provident fund

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

The candidate should be M.Sc. (Preferably Microbiology) / M.Pharm/Quality Assurance) with at least 10 /12 years of relevant experience in medical devices industry. IPQA, QMS, Validation, compliance , QA related to its processes and strategy.

Responsibilities: * Implement Change Control procedures during deviations/CAPAs. * Conduct BPR reviews, BMR analysis, GMP compliance checks. * Ensure product quality through process validation and CAPA implementation.

To take plant rounds for monitoring production operations. To review BMRs, BCRs, and analysis records before the release of API. To perform sampling of APIs, maintain its records, and ensure the cleaning of sampling tools. To provide line clearance at the time of product change over. To perform the documentation control activity at the site. To monitor/Maintain/Review Records and Handling of controlled/Retained samples of Intermediates/Finished API/KSM.

Role & responsibilities : • Responsible for Leading the Quality function and day to day In-process Quality verification with consistent result both in terms of Quality and Quantity to meet daily plant output/customer requirements. • Performing in-process quality inspection for accuracy, specification parameters and workmanship. Develop and implement best quality processes in production • Tabulate and document data relating to products, processes, materials, its qualities, and reliabilities. • Train staff, technicians, and professionals on the aspects of quality control activities. • Troubleshoot and resolve problems relating to quality using quality tools ( analysis of COPQ in order to achieve savings.DMAIC, 8D, 4Q, PDCA etc.) Capture and PDCAP-YY7 • Conducting regular Inspections and Audits to assess product quality and compliance with established standards. • Collaborating with production teams to Identify areas for improvement and develop solutions to address quality Issues. • Ensuring that all quality-related processes comply with local and international regulations and standards. • Providing training and support to production teams to improve their quality control skills and knowledge. • Reviewing customer feedback and using this information to identify areas for improvement. • Support during Customer Intections, QA drafting and approvals etc. Implementing Poka-Yoke wherever possible to prevent quality errors and improve safety level. • Support and lead continuous improvement programs, problem solving and process improvement activities. • Adhere to QMS, other company policies and procedures & Quality Documentation Control. • Strong Technical know-how about the Process flow. KAIZEN & ISO-9001 and 14001,45001 Documentation. • Strong Knowledge about the Corrective Action Plan (8D), Continual Process Improvement. • Shows moral courage, openness and honesty in all dealings. Good communication and interpersonal skill. Skills required: 1.English Communication skills, 2.Good local launguage Communication Skills 3.Good Knowledge in Excel & PPT 4.Team management

EXL Services.com ( I ) Pvt. Ltd. is looking for Senior Executive to join our dynamic team and embark on a rewarding career journey Leading the full audit cycle by checking tax compliance, verifying financial records, and inspecting accounts. Analyzing the results of the audit and presenting possible solutions for ineffective financial practices to management. Evaluating company accounting procedures, payroll, inventory, and tax statements to guide financial policymaking. Conducting risk assessments to recommend aversion measures and cost savings. Following up with management to ensure remediations are implemented into the company's financial practices. Supervising junior auditing personnel and implementing their research work into the auditing process. Preparing and reviewing annual audit memorandums. Researching applicable federal and state laws and regulations to ensure the company's books are compliant.

Role & responsibilities Responsible for defining QA strategy, approach and execution in the field of document control, IPQA, qualification/validation, GLP, training activities etc. and responsible for leading and directing QA team To approve SMF, VMP, quality manual and validation protocol. To conduct internal audit / self-inspection to ensure compliance to GMP and another regulatory requirement. To arrange management review meeting and escalate the outcome of quarterly report to management. To handle the Market Complaints and to participate in Product Recall. To approve quality system documents likes Change controls proposals, Deviations, Incident reports, CAPA reports, OOS and OOT, NCR, Market Complaints, product recalls and Returned goods. Responsible for review and approval of new as well as revised related Specification, Standard Test Procedure and Analytical Work Record. Responsible to design validation/ qualification strategies Responsible for validation /qualification of processing equipments, cleaning equipments and testing equipments on time. Responsible for day-to-day validation planning and execution activity. Responsible to approve specifications, standard test procedures and analytical work records. To approve quality management system documents i.e. change controls, deviations, incident reports, out of specifications, out of trends, non-conformance reports, market complaints, product recalls, returned goods, corrective and preventive action reports. Responsible for regulatory & customer audits preparation, execution and its compliance. To approve and authorize technical agreements from customer and outside party. Responsible to coordinate with regulatory department for submission of dossiers and documents to regulatory department. Responsible to make the management aware of any deviation/non-compliance or any other quality related issues during validation/ qualification & processing. To ensure the implementation of quality risk management procedures. Responsible to finalize training topics as per requirement and organize annual training plan with Training coordinator on cGMP and technical aspects. To ensure that processes needed for the Quality Management System are established, implemented and maintained. Responsible for investigation & review of non-conforming events including customer complaints and internal non-conforming events. Responsible for report, review, evaluation and tracking of change control, deviation, incident, market complaint, non-conformance report, product recall, corrective and preventive action. Responsible to ensure that a document control procedure is adopted to approve, review and update all changes to critical documents within the scope of Quality Management System. Responsible to perform vendor audits and internal audits. To check audit trial and back-up verification documents. Participation in study raised through Quality Management System.

Overview We are seeking a highly organized, proactive, and detail-oriented Executive Assistant to support our Senior Vice President (SVP). This role requires a high level of professionalism, discretion, and the ability to anticipate needs while managing a wide range of administrative and executive support tasks in a fast-paced environment. Responsibilities Manage and optimize the SVPs calendar, scheduling meetings, appointments, and travel arrangements. Prepare, review, and organize correspondence and other confidential documents. Coordinate internal and external meetings, including logistics, agendas, and follow-ups. Serve as a liaison between the SVP and internal/external stakeholders. Handle expense reports, invoices, and budget tracking as needed. Maintain strict confidentiality and discretion in all interactions. Taking care of all activities related to SVPs office. Visa processing. Maintaining & Updating tracking tracker. Qualifications Bachelors degree preferred; equivalent experience considered. Minimum of 5 years of experience in an executive support role, preferably supporting C-level or SVP executives. Exceptional organizational, time management, and multitasking abilities. Strong verbal and written communication skills. Proficient in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint); familiarity with collaboration tools like Teams and Concur is a plus.

Urgent Requirement for Rabale MALE Candidate Knowledge Required:- Good knowledge of 21 CFR Part 11 / Annexure 11 (Must) Good knowledge of CSV,GAMP 5 (Must) Good knowledge of Data Integrity requirements for Pharma (Must) Experience of working at Pharma Site QC,QA,IT,CSV etc Must Experience Candidate with 3 - 5 years of experience in Pharma/Life science domain working knowledge in authoring on Computer System Validation Deliverables, Part 11/Annex 11, Data Integrity Work experience in Pharmaceutical Sector will be desirable Experience in Authoring all CSV deliverables e.g. URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment, etc Experience on validation of any of the enterprise level applications. e.g. Documentum, LIMS, LMS, , etc. Author, review and approval of SOPs, Guidelines/Policies as applicable. To have functional knowledge of Regulatory guidelines, Quality and Manufacturing processes. A team player with good communication skills (verbal & written)

JOB PROFILE OF SR. TECHNICAL OFFICER-QUALITY ASSURANCE MENDINE PHARMACEUTICALS PVT LTD Job Title / Designation- SENIOR TECHNICAL OFFICER - QA Qualifications- M.PHARM Experience- 5 to 6 years experience in QUALITY ASSURANCE Job Objective- The ideal candidate will be responsible for implementing and maintaining quality systems, ensuring compliance with cGMP guidelines, conducting internal audits, reviewing batch records, and supporting regulatory inspections. This role demands strong documentation skills, a sound understanding of pharmaceutical quality standards, and the ability to work collaboratively across departments to uphold product integrity and safety throughout the manufacturing process. Job Responsibilities 1) Quality Risk Management 2) Batch Manufacturing Record preparation 3) Process Validation 4) Packaging Material Specification Preparation 5) APQR 6) Cleaning Validation 7) Regulatory Affairs activity 8) Dossier preparation 9) Application of ONDLS system 10) Form 29 & Form 30 preparation 11) Endorse documents preparation 12) New drug application 13) COPP application in ONDLS.

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile and Allergy Therapy Products, and Generics Solid Dosage Formulations. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma which is subsidiary to Jubilant Pharmova Limited. Jubilant Generics have 2 manufacturing sited at Roorkee, Uttarakhand and Salisbury, Maryland, USA engaged in manufacturing of Tablets and Capsules. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business team focusses on B2B model for EU, Canada and emerging markets. Kindly refer www.jubilantpharmova.com for more information about organization

Currently we are hiring Q.A officer for our pharma manufacturing industry. Requirement:- Qualification:- M.Sc./Pharma/Pharma Experience :- Fresher can apply Location:- Panoli (Gujarat) Salary :- As per company norms Benefits:- PF/Bonus

Novo Nordisk Global Business Services (GBS) India Department GCM DP RoW Job Location Hyderabad Are you an expert in aseptic manufacturing with a strong quality mindset and a desire to make a tangible impact on global healthNovo Nordisk is seeking a dedicated Manufacturing Specialist to join our Global Contract Manufacturing Drug Product (GCM DP) team in Hyderabad, India. In this role, you''ll be crucial in ensuring the high-quality production of life-saving insulin and GLP-1 products through our Contract Manufacturing Organizations (CMOs). ! The Position As a Manufacturing Specialist (SME), you''ll be the go-to expert driving Technology Transfer projects for commercial products, ensuring top-tier quality with our Contract Manufacturing Organizations (CMO) partners. Your key responsibilities will include: Lead cross-functional teams, ensuring seamless collaboration between Novo Nordisk as the sending Unit and Contract Manufacturing Organizations (CMOs) partners as the receiving Unit. Act as a mentor and support Contract Manufacturing Organizations (CMOs) to ensure Novo Nordisk products are manufactured to the highest quality standards. Provide training, share best practices, and review and approve validation documents to safeguard compliance. Offer oversight and support during the planning and execution of validation and qualification activities. Define, manage, and deliver on complex projects in collaboration with CMOs, Quality Assurance, and project managers. Drive problem-solving initiatives and provide scientific and technical solutions within tight project timelines. Qualifications Bachelor’s /Master’s degree in engineering. Possess 10+Years experience and relevant 5 years of manufacturing experience, especially in an international, multicultural environment. Expertise in aseptic manufacturing processes is non-negotiable. Capable of communicating naturally and effectively with stakeholders at all levels with adept at finding solutions and motivating stakeholders to achieve ambitious goals. Possessing a strong mindset, a focus on continuous improvement, and keen attention to detail. Demonstrates the ability to work independently with minimal supervision, a strong willingness to learn new skills, and the motivation and flexibility to thrive in a fast-paced, dynamic environment. About the Department GCM DP RoW Projects is dedicated to delivering life-saving insulin and GLP-1 to patients in regions such as Africa, India, the Middle East, and Asia. By partnering with CMOs in these areas, the department plays a pivotal role in improving the quality of life for patients living with diabetes and obesity. With a focus on Market Access initiatives, the team tailors projects to meet the unique requirements of each country, offering exciting growth opportunities. The department thrives on innovation and problem-solving, overcoming challenges and navigating complex regulatory landscapes to deliver insulin and GLP-1 on a global scale. Based in Hyderabad, India, you’ll join a diverse and dynamic team committed to making a difference.

Novo Nordisk Global Business Services (GBS) India Department: GCM DP RoW Location Hyderabad, India Are you an experienced aseptic manufacturing project manager with a strong technical background and a passion for making a direct impact on patients'' livesDo you thrive in an international environment where cultural awareness is key to your successIf so, this could be your dream role! ApplyNow! The Position As a Project Manager in Aseptic Manufacturing, you will lead and mentor cross-functional teams, including both Novo Nordisk and our Contract Manufacturing Organisation (CMO) partners. It includes, Ensure the seamless Technology Transfer and manufacturing of our commercial products, always upholding Novo Nordisk''s stringent quality standards and adhering to cGMP and regulatory requirements. Lead and manage aseptic manufacturing projects, specifically leveraging your expertise in areas like Formulation/Compounding, Filling, Washing & Sterilisation, Environmental Monitoring, or Clean Utilities. Developing and managing detailed project plans and timelines and communicating effectively with steering groups and key stakeholders. Monitoring progress and proactively securing necessary resources. Developing project risk grids and identifying mitigation strategies with both Novo Nordisk and our Contract Manufacturing Organisation (CMOs). Qualifications Bachelor’s or Master’s degree in engineering. Possess experience of 5-12Years of project management experience with a proven track record of successful project delivery in a highly regulated environment, especially internationally. Aseptic manufacturing experience is a must, and experience with Technology Transfer of biologics is a significant advantage. Professional experience balancing individual drive with effective stakeholder involvement. Proficiency in project management software (e.g., MS Project, Smartsheet, Jira, or equivalent). Demonstrated fluency in written and spoken English is essential. About the Department GCM DP RoW Projects is a dedicated team committed to providing life-saving insulin and GLP-1 to patients in regions such as Africa, India, the Middle East, and Asia. By partnering with CMOs in these areas, the department strives to make a meaningful impact on the quality of life for patients living with diabetes and obesity. Our projects are tailored to meet the unique requirements of each country, offering exciting growth opportunities. With a steadfast commitment to innovation and problem-solving, we work to overcome challenges and navigate complex regulatory landscapes to deliver insulin and GLP-1 on a global scale. Join us in making a difference.

Perform line clearance activities prior to production operations. Review Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and Batch Filling Records (BFR). Execute in-process QA checks and verifications during manufacturing and packaging. Manage control sample collection, storage, and documentation. Collect in-process, finished product, and customer complaint samples as required. Compile Annual Product Quality Review (APQR) data and perform trend analysis. Participate in process validation, hold time studies, and related quality activities. Coordinate with relevant departments for timely batch release. Conduct routine GMP checks in production, warehouse, and other relevant departments. Coordinate and review vendor management documents and compile vendor assessment reports. Manage document archival as and when required in compliance with applicable procedures. Issue and control formats, Standard Operating Procedures (SOPs), specifications, and batch records. Qualifications: B.Pharma/M.Pharma/M.Sc (Chemistry) Exp.- 5-10yrs

Roles and Responsibilities: ONLY FOR MALE CANDIDATES Conduct quality assurance activities such as BPR review, BMR review, SOP preparation, validation, cleaning validation, equipment qualification, process validation, stability analysis, and OOS/OOT investigations. Ensure compliance with regulatory requirements by maintaining records of batch manufacturing, testing results, and other relevant documents. Develop and implement quality control procedures for bulk drugs production. Perform analytical testing of APIs using HPLC/GC techniques.

Role & responsibilities: The candidate would be required to take on the responsibility of ensuring quality product and production efficiency. Some of the key responsibilities that may be given are: 1. Review and maintain batch records, SOPs and quality documentation. 2. Conduct in-process checks and ensure GMP compliances. 3. Perform internal audits and assist in external audits (FDA, WHO, ISO, etc.) 4. Handle deviations, CAPA, change controls, and OOS investigations. 5. Ensure data integrity and documentation as per regulatory requirements. 6. Coordinate with QA, QC and Production teams to maintain quality standards. 7. Carry out validations and risk assessments Preferred candidate profile: The candidate should be hardworking and honest. Should be able to manage time, prioritize work accordingly and work well within a team. Proficiency in MS Word/excel and English is mandatory. Experience in testing is desirable but Freshers may apply

Role & responsibilities Line clearance in Packaging and Manufacturing area. Handling IPQA Maintaining of all documents related to manufacturing areas as per WHO, GMP. In Process Quality Assurance Schedule and coordinate batch record issuance. Arrange for the effectiveness of SOPs in Documentum software. Preferred candidate profile Preferred candidates from OSD background only.