271 Process Validation Jobs - Page 2

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 6000 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 70 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary To Manage the entire qualification and validation activities in the site specifically related to equipment/utility qualification, cleaning validation, process validation, packaging validation and perform the activities in compliance with the various regulatory guidelines and standards. To monitor regular activities related to quality validation and engineering as per established procedures. Job Responsibilities Review and approval of documents pertaining to equipment/utility qualification, cleaning validation, process validation, hold time studies and packaging validation. Approval of layouts, yearly & monthly schedules, to be added planners. SME for Qualifications and Validations during Regulatory audits and ensuring compliance to regulatory requirements. Assess change controls related facility, equipment, process, utility, cleaning and packaging. Review & approve of standard operating procedures. Co-ordination and implementation of training activities of team members. Responsible for review of site VMP s (Validation Master Plan) and related documents. Responsible for review and approval of process validation & cleaning validation protcolsand reports. Co-ordinate with cross functional teams in Investigations carried out at ARPL. Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance and Passion, Demonstrates strong and visible support of our values. Performs all work in accordance with all established regulatory and compliance and safety requirements. All other duties as assigned as per the expertise in the relevant subject. Job Requirements Education Minimum Bachelor of Pharmacy/ Science or any equivalent degree. Knowledge, Skills and Abilities Possess sound knowledge in Qualification and Validation of Equipment, Facility, Utilities, Process and Cleaning Maintains good Interpersonal skills and communication skills. Strives to drive projects related to Validations & Engineering effectively. Experience Minimum 12 - 15 years of experience in GMP Regulated pharmaceutical industry At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

Role & responsibilities To execute activities related to R&D Process Development, along with a group comprising of Research Officers/ Research Assistants under guidance from the Project Leader/Group Leade Require to Plan and carry out Chemistry related experiments, recording the observation in Protocol Computer literacy etc. Job Description: Literature search with respect to assigned project and its documentation Experimentation (Process development, optimization and validation) Analysis, interpretation (HPLC, IR, NMR, Mass and CHN) and documentation of data General Laboratory Management etc. Scale-up and Technology transfer activity Project related impurities synthesis.

Role & responsibilities Process control Seamless working with shop floor team for process improvement activities Innovate and implement robust processes to minimize the deviations in components Preferred candidate profile Hands on experience in process technology and trouble shooting . Should have hands on experience in analyzing and understanding of process problems and provide the guidance for improvements. Usage of analytical tools and technique to address non-compliances in components and provide the solutions

Valeo is a tech global company, dedicated to designing innovative solutions that redefine mobility. As an automotive supplier partner to automakers and new mobility players worldwide, our primary focus is to create a greener and more secure form of mobility. Our solutions are geared towards enhancing the driving experience and reducing CO2 emissions. With a reputation as a leader in our industry, we are widely recognized as one of the largest and most innovative companies on a global scale. Your mission in this role will involve leading the industrialization of the new P1 project, enhancing production efficiency in terms of both machinery and direct labor within your designated area. Additionally, you will be responsible for sharing and capitalizing on industrial process knowledge in your domain, contributing to the design of new equipment and production lines, and leading Lean design workshops. Your responsibilities will include managing the introduction of production equipment using IPROM, overseeing the development of equipment and assembly lines with suppliers, designing small tools, and validating supplier proposals. You will also be tasked with defining acceptance criteria for new equipment or production lines, conducting pre-acceptance and acceptance procedures, performing trials on production lines, and generating detailed reports. Building and implementing action plans to ensure readiness for FDPR, evaluating equipment capabilities and processes, setting up equipment, proposing process validation plans, and participating in PFMEA and CONTROL PLAN activities will also be part of your role. During mass production, you will be responsible for monitoring quality, cost, delivery, and management (QCDM), suggesting improvements, optimizing equipment performance, reducing cycle times, updating information system routings with SPV validation, supporting production technicians, maintaining contact with suppliers for improvement and support, participating in SPV workshops, and contributing to APU QRQC activities. Furthermore, you will play a key role in standardization by validating PG RAISE and CdC standards created by Standard Owners, approving any proposed changes to standards from sites, applying and promoting standards within your domain, and adhering to SPV rules. It will also be essential to ensure compliance with safety and environmental procedures established by the Valeo Group, uphold 5S standards, report any issues, and promptly address safety violations. As a Process/Manufacturing Engineering Engineer/Technician within the Technical Center, you will be employed on a full-time, regular basis with a permanent contract. The job posting date is 2025-03-18. Join our team and become part of: - One of the largest global innovative companies, with over 20,000 engineers engaged in Research & Development - A diverse and multicultural environment that values international collaboration and diversity - More than 100,000 colleagues across 31 countries, offering numerous opportunities for career advancement - A business deeply committed to minimizing its environmental impact, recognized as the top automotive company in sustainable development by Corporate Knights For more information on Valeo, please visit our website: [Valeo Website](https://www.valeo.com),

As an Assistant Manager/Manager Project, you will be required to possess a B.E/ B. Tech in Dairy Engineering. You should be proficient in English, Hindi, and Marathi languages and fall within the age bracket of 25 to 35 years. The ideal candidate should have a minimum of 6 to 12 years of experience, preferably in the Dairy Processing/Food Industry. Your key responsibilities will include having a deep understanding of various dairy products such as Liquid Milk, Butter, Ghee, Powder, Cheese, Paneer, Whey Processing production, preservation, and utilization. You must have prior experience in Green field/Brown field Project conceptualization, detail engineering, Planning, Budgeting, execution, commissioning, and Project Handover process. Proficiency in Equipment design, selection criteria, GMP concept, Process flow, HACCP, AutoCAD, MS Project, and ensuring technical and quality control of the Dairy processing industry is essential. Your role will involve working on Plant Equipment Saturation, debottlenecking, and equipment OEE. Additionally, you will be responsible for preparing FDS of the process, control matrix, process validation, and Process Mapping for the optimum utilization of equipment. Budget preparation, tender document preparation, project Gantt Chart, Execution schedules, project tracking, commissioning, and coordination with various vendors will be part of your daily tasks. You will play a vital role in Project KPI monitoring, tracking, and ensuring process validation through inter-department coordination. Project site coordination with subordinates, multiple vendors for Process equipment, utility, and Civil will also be under your purview. Your expertise will be crucial in ensuring the successful execution of projects and meeting process requirements effectively.,

* Opening Position * Sales and Application Engineer Requirements : * BE/ B.Tech/ Dip (Mechanical/ EEE) * 3+ years of relevant industrial product sales experience. * Key skills: Hydraulics, Pneumatics, Electrical actuators, Process Valves * Basic Requirement : Two-wheeler and Laptop * Location: Bangalore, Mumbai, Gujarat, Delhi, Coimbatore, Hyderabad, Chennai. Considerable Profile/ Department: 1. Sales profile with technical knowledge in hydraulics, pneumatics, process valves are highly preferrable. 2. Maintenance profile interested for sales and know basic industrial regions are preferrable. Mandatory Requirement: *Two wheeler, Driving License, Laptop *Key skills Field sales , Pneumatics, Hydraulics, Process Valves. extensive customer base knowledge related to hydraulics or pneumatics in regional areas. good communication skill in regional language and English, customer convincing skill, Basic Requirement: Two wheeler, Laptop Thanks & Regards Mrs. Santhiya HR - Recruiter 8008695894 Access Management Consultancy F1, Leela Regency, No.17/8, Morrison 2nd Street, Alandur, Chennai-600 016Role & responsibilities Preferred candidate profile

As a Qualified Person within the Quality department at Piramal Critical Care (PCC) in Haarlem, Netherlands, your primary responsibility will be to certify batches of Medicinal Products before release for sale. This includes ensuring compliance with EU-GMP regulations, relevant EU-directives such as 2001/83/EC and 2011/62/EU, Dutch National Legislations, and overseeing that public service obligations are met. Collaborating with key personnel like heads of production, quality control, quality assurance, and supply chain, you will be responsible for supervising the company's activities to ensure continuous compliance with legal requirements. It is essential for the Qualified Person to be regularly present at the facilities where the operations take place. Your role as a Qualified Person involves certifying and confirming that each finished medicinal product batch complies with GMP, Marketing Authorization, and applicable EU and Dutch National laws. You will also be responsible for evaluating deviations, participating in investigations, recording certifications, approving subcontracted activities, and ensuring self-inspections and audits are conducted regularly. Additionally, you will play a crucial role in approving quality agreements, change controls, process validations, and participating in risk assessments, audits, and inspections. It will be your responsibility to keep appropriate records of delegated duties, decide on the final disposition of products, handle customer complaints, and ensure GMP aspects are implemented and maintained in the quality management system. To qualify for this role, you should be eligible to act as a Qualified Person under EC/2001/83 Directive, have experience in certifying sterile and solid unit dose products, and possess some background in quality assurance for narcotic products. Fluency in Dutch and English at a minimum C1-level is required. At Piramal Critical Care (PCC), we are committed to inclusive growth and ethical practices. We offer equal employment opportunities based on merit, ensuring that all applicants and employees receive fair treatment in personnel matters. Join our team dedicated to delivering critical care solutions globally and contributing to sustainable and profitable growth for all stakeholders.,

The ideal candidate for this role will be responsible for updating self-hygiene practices and ensuring adherence to standard operating procedures within the sterile manufacturing department. You will be in charge of preparing, reviewing, revising, controlling, and implementing SOPs, master documents of production, protocols, and reports. Additionally, you will manage documentations like BMRs, BPRs, and master SOPs, as well as handle change control, deviations, CAPA, investigations, and various manufacturing operations such as filling, sealing, labeling, and packing. Furthermore, you will be required to create production planning on a monthly and daily basis, prepare daily production reports, ensure equipment validation and calibration, and maintain compliance with cGMP, GDP, and departmental discipline. Monitoring manufacturing records, providing training to subordinates, technicians, and operators, and executing tasks as instructed by the HOD are also part of your responsibilities. Moreover, attending training sessions as per schedule, maintaining facility compliance, and ensuring the area is inspection-ready are crucial aspects of the job. Proficiency in equipment operation, cleaning, dispensing, sterilization, filtration, process validation, troubleshooting, and people management will be valuable skills in this role. The preferred educational background for this position is a B.Pharma or M.Pharma degree, along with a total experience of 15 to 18 years in a sterile manufacturing plant.,

You will be responsible for performing commissioning and qualification of Pharmaceutical equipment, specifically systems for Oral Solid Dosage, Injectables, and Fill/Finish. This includes a variety of equipments such as RMG, CoMil, Tablet press, Coating Machine, blister packing machine, Vial Filling Line, PFS Line, Isolators (Negative & Positive), RABs (Open and Closed), GL Reactors, Dryer, Nutsche Filters, Centrifuges, Lyophilizers, etc. Your responsibilities will include developing CQMP, VMP, FRA, cGMP review sheet, interdependencies, System boundary, URS, SCA/SLIA, CLIA, DQR, SRA/QRA, SAT protocol, commissioning protocol, IQ protocol, OQ protocol, PQ protocol, process validation, and cleaning validation protocol. You will execute Commissioning, qualification, and validation activities for Pharma Process Equipments for API, Fill/Finish, and OSD. Additionally, you will review, analyze, and interpret system performance data, handle deviations/discrepancies, conduct investigations, CAPA, and ensure promotion of cGMP and regulatory compliance in assigned projects. Furthermore, you will exercise good judgment in selecting methods and techniques for obtaining solutions, maintain GDP, ALCOA practices, and have hands-on experience with Pharma Process Equipments. Drafting equipment operation SOPs will also be a part of your role. Qualifications & Other Requirements: - BS/MS in Engineering (Chemical, Pharma). - 4-10 years of experience in validation, quality systems, operations, engineering, or a combination thereof. - Experience in multiple GMP validation disciplines with advanced technical knowledge. - Knowledge of Validation Lifecycle approach, international regulatory requirements, and standards. - Experience with Documentum or Maximo is a plus. - Strong verbal and written communication skills, excellent organizational and time utilization skills. - Ability to work independently and within project teams. - Industry experience related to cGMP drug manufacturing, validation, and chemical process design. - Strong computer knowledge including Microsoft Office products.,

Execution of technology transfer to Sun/CMO Site transfer, Scale up, Exhibit, Process validation batches plan with effective planning and utilization of men, materials and machineries. Documentation work like new production introduction form, Scale-up reports, review of Sun/CMO BMR, sampling plan, PV protocol, URS preparation, and Dashboard preparation. To ensure that product is produced and stored according to the appropriate documentation in order to obtain the desired quality. Responsible for Review comments of MF, FMEA, RA protocol (Sampling plan, Process validation protocol) and compliance. 5. Handling Support of Trouble shooting batches for data comparison and route cause Investigation at Sun/CMO. 6. Investigation for product trouble shooting 7. To ensure that the Packing operations or activities are carried out on timely. To monitor prior checkup of equipment planned for usage in Scale up, Exhibit, Process validation batches i.e. Equipment preparation, vial washing dehydrogenation, CIP/SIP System, PLCs, instruments etc. Responsible for Supervise and perform skid trials for better product development and process improvements and also minimizing manufacturing related constraints in future. To prepare the Scale up report, get evaluated and signed by authorized person prior going to Exhibit batches their submitted to QA. Responsible to help the officers and operators to standardize production activities to achieve better efficiency and quality. To review validation protocol, SOP and other cGMP Documents. Close coordination with all the supporting departments i.e. Production, NPQC, QA, QE (Engineering) and warehouse for smooth running of Scale up, Exhibit, Process validation batches. 14 To ensure the compliance of various in-process control instructions provided in MF, FMEA, RA, BMR, and MBMR5.

Responsible for following activities in purification area of BM/BU based on campaign basis 1. Following GMP, safety practices in production facilities and work place. 2. Responsible for production activities: Execution of area, line clearance before execution of activities. Execution of product changeover activities. Responsible for column cleaning, packing, unpacking, evaluation and maintenance. Responsible for drug substance (FDS) transfer/dispensing. Execution of production activities. Monitoring and review of batch parameters/performance. Ensuring material are arranged properly before activities. Verification of samples for analysis. Responsible for shift Monitoring. Handling of online reject material. Review of soft copy for batch monitoring and performance. Execution of process validation. Execution of cleaning validation. Execution of verification protocols/equipment specific protocols. Ensuring buffer preparation in respective shift. 3. Handling of documents: Preparation of new / revision of SOPs, protocols and reports. Preparation of MFRs and BMR's. Primary review of executed BMR's submission to QA. Ensuring online BMR's updation and review of log books. 4. Responsible for monitoring and operation of following production equipments (but not limited to): AKTA Process Purification system Conductivity meter TFF System Peristaltic pumps Weighing Balance Mixing Systems Biosafety cabinet Filter integrity tester pH meter Walk in cold Freezer room Heat Exchanger Mixing vessels Ensuring proper data backup of equipments. Provide clearance for calibration, PMP and validation of equipments. Participate in execution of equipment validations. 5. Responsible for Quality Management Systems Initiation / Review of breakdown request. Initiation of CRN's and Preparation of Risk Assessments. Initiation of incidents, investigation, CAPA. 6. Team member: Facility readiness for audits. 7. Training: Training team members on SOPs / GMP aspects. Attending training on related SOP's / GMP aspects. 8. Monitoring of PM/Qualification of purification area equipments. (Calibration / PMP/Qualification).ease enter job description

1.To involve in plasma products manufacturing. 2.Follow shift and production schedules. 3.To complete the assigned trainings timely. 4.To Monitor the differential pressure, temperature and humidity of the classified area. 5.To Ensure the area, equipments cleaning and readiness of equipments for batch activity. 6.Preparation of buffers and other solutions for downstream process. 7.Handling of process related instruments and equipments in downstream process (DSP). 8.Perform all the assigned manufacturing activities as per the defined procedures (SOP, BMR, Protocols) and record the details in respective document. 9.Checking the availability of stock of chemicals, solvents, raw material etc. 10.Coordinate with cross functional teams for smooth batch operations. 11.To maintain the facility to compliance with GMP. 12.Responsible for execution of relevant documents as per GDP. 13.To involve in equipment qualification and validation of the downstream equipments. 14.To involve in execution of process validation batches and regular manufacturing batches. 15.Provide samples to QC and take follow up for QC testing result. 16.In case of any abnormalities/ deviation observed should be recorded and informed to process in-charge to avoid any quality issues in the product. 17.To ensure adherence to safety procedure and report unsafe conditions and incidents to Supervisor.

1. Follow shift schedule and production schedule as per process requirement. 2.Handling of plasma collection, sanitization, washing, cutting, pooling and thawing. 3.Handling of plasma fractionation process steps. 4.Compliance to all approved procedure, documents and GMP activities. 5.Performing all the assigned manufacturing activities in confirmation to BMR, protocols and recording the details in record sheets and logbooks. 6.In process samples sending to QC for analysis. 7.Performing COP, CIP, PHT and SIP of all the process vessels and equipment. 8.Performing calibration of pH, conductivity meters, turbidity meter, weighing balances and other equipment. 9.Preparation of buffers and other solutions for plasma fractionation process. 10.Monitoring of area cleaning, equipment surface sanitization, differential pressure, temperature and humidity 11.Monitoring and recording the temperature of freezer room and cold room. 12.To get involved in trouble shooting and managing day to day activities. 13.Checking the availability of stock of chemicals, solvents, raw material etc. 14.Report unsafe conditions and incidents to shift in-charge. 15.Adherence to safety procedures. 16.Awareness on PPE usage.

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. 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. Follow SOPs, GMP and safety practices. 2. Facility Area cleaning, Equipment cleaning, drains cleaning sanitization. 70 % IPA arrangement. Discarding general waste, rejects and biowaste. Log books updation. Spillage management. Updating of BMRs and annexures online. 3. Material Arrangement of plastic / glassware. Material packing for sterilization. Arrangement of garments. Arrangement of materials. 4. Process Arrangement of drums and installation of bags. Collection of WFI. Movement of prepared media/buffer to process rooms. Assisting in cleaning of equipments. Movement of samples. Execution of production activities. Monitoring of batch parameters. Arrangement of HDPE Drums, Vessels and installation of SUM bags and liner bags. Samples handling (Sampling and labelling). Handling of Depth filters assembly and harvest activities. Media Buffer preparation activities for process. LN2 container handling for filling activities. 5. Participate in training programs as per training schedule. 6. Responsible for operation of following production equipments (but not limited to): Mixing systems Weighing balance Magnetic stirrer Peristaltic pumps pH meter Cold Room Freezer Heat exchanger Depth filter holders Laminar air flow cabinet Biosafety cabinet Pass box LN2 container

Responsible for production activities 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. Handling of documents Checking practical feasibility of new / revised SOPs, protocols. Updation of log books. Updation of BMRs and attaching annexures online. 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 Training: Attending training on SOP's / GMP as per schedule.

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.

* Opening Position * Sales and Application Engineer Requirements : * BE/ B.Tech/ Dip (Mechanical/ EEE) * 3+ years of relevant industrial product sales experience. * Key skills: Hydraulics, Pneumatics, Electrical actuators, Process Valves * Basic Requirement : Two-wheeler and Laptop * Location: Bangalore, Mumbai, Gujarat, Delhi, Coimbatore, Hyderabad, Chennai. Considerable Profile/ Department: 1. Sales profile with technical knowledge in hydraulics, pneumatics, process valves are highly preferrable. 2. Maintenance profile interested for sales and know basic industrial regions are preferrable. Mandatory Requirement: *Two wheeler, Driving License, Laptop *Key skills Field sales , Pneumatics, Hydraulics, Process Valves. extensive customer base knowledge related to hydraulics or pneumatics in regional areas. good communication skill in regional language and English, customer convincing skill, Basic Requirement: Two wheeler, Laptop Thanks & Regards Mrs. Santhiya HR - Recruiter 8008695894 Access Management Consultancy F1, Leela Regency, No.17/8, Morrison 2nd Street, Alandur, Chennai-600 016Role & responsibilities Preferred candidate profile

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.

Validation Master Plan (VMP, PVMP, CVMP, QMP) Qualification and Validation Documents and execution BMR, BPR, log book, Protocol, Report and SOP Required Candidate profile Preparation and review of PPQ and cleaning validation protocol monitoring of PPQ and cleaning validation activities To prepare and review (SOP's) and procedures related to validation

Role & responsibilities : Should handle and lead project individually(with help of CFT) through APQP Proficiency in quality core tools like control plan, FMEA problem analysis Expert in MS office well known handling Japanese OEM customers do product validation process validation Homologation testing Preferred candidate profile Immediate joiner