271 Process Validation Jobs - Page 10

Glowria Lifecare Pvt. Ltd. is looking for QA Officer to join our dynamic team and embark on a rewarding career journey. Develop and implement quality control processes and procedures.Conduct audits of production processes and facilities to ensure compliance with regulations and quality standards.Develop and maintain documentation related to quality control activities.Investigate and resolve quality issues, working closely with production, engineering, and other departments.Develop and maintain product or service specifications, quality plans, and procedures.Monitor and analyze quality data to identify trends and opportunities for improvement.Train employees on quality control processes and procedures.Collaborate with suppliers and customers to ensure quality requirements are met.Manage and report on quality control metrics.Ensure compliance with all regulatory requirements and standards.Knowledge of quality control principles, practices, and procedures.Strong analytical and problem-solving skills.Excellent communication and interpersonal skills.

About Amgen Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Sr Validation Engineer What you will do Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. In this role you will be serving patients through internal collaboration with Amgen’s global quality teams, manufacturing sites and external engagement with contract manufacturing organizations. You will make key contributions to fulfill Amgen’s missions of serving patients by ensuring supply of high-quality product produced at contract manufacturers to patients. The Senior Validation Engineer will oversee strategies and documents related to DS/DP Process Performance Qualification, Cleaning Validation, and Packaging Qualification at contract manufacturing organizations (CMOs) located across North America, Europe and JAPAC regions. The candidate should have prior experience with qualification of the following modalities, primarilysynthetic API/DS and DP manufacturing, FDP and packaging qualification, and aseptic DP. Be an integral quality member of Amgen cross-functional contract manufacturing teams that includes but is not limited to operations, analytical science, process development, supply chain, etc. Project teams will includetech transfers, new product introductions, and ongoing validation maintenance activities. Roles & Responsibilities: Translate Amgen requirements into the language of the CMO Identify and assess validation/quality risks to enable risk-based decisions Validation document author/approver Determine appropriate sample plans and acceptance criteria for primary and secondary packaging processes. Aseptic processing system oversight (media fill, autoclave validation, EM) Prepare materials/documents (playbooks) for topics to be presented during audits/inspections Perform validation change control assessments Review/approve validation deviations Review/approve Master Batch Records Perform Person in Plant activities as required Escalate issues to Validation/Quality management, as needed Author Validation sections of Marketing Applications Write/review responses to regulatory questions (RTQs) Drive Operational Excellence and Champion Change Authority: Determine outcome of validation activities Decision to approve or reject validation documentation Provide input on Validation position on related topics and strategy for the site Decision to approve Master batch Records This role may require working in shifts or extended hours within the same shift to support global time zones. What we expect of you Basic Qualifications and Experience: Doctorate degree OR Master’s degree with 4 to 6 years of experience in process validation or a related field OR Bachelor’s degree with 6 to 8 years of experience in process validation or a related field OR Diploma with 10 to 12 years of experience in process validation or a related field. Functional Skills: Must-Have Skills: Prior experience serving as Validation lead for NPI or tech transfer of manufacturing processes. Relevant experience in qualification of finished drug product and packaging processes. Minimum of 6 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations. Ability to have a positive impact on others; the ability to affect the behaviors of others by connecting with and inspiring them Good-to-Have Skills: Working foundation in cleaning validation and aseptic process simulation.Experience in resolving complex deviations associated with validation studies. Understanding of the applicable manufacturing/testing processes (i.e. Synthetic API, Drug Substance, Drug Product, Packaging, Device manufacturing processes). Proven experience in designing and/or improving processes at conceptual level Desire to partner with internal and external stakeholders across teams Understanding of industry requirements/expectations that comprise a robust Validation package. Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Candidate should have experience on activities listed below but not limited to Scale up of process from Lab to Pilot to Commercial. Process validation of new molecules for regulatory filings Process validation of Cost Improvement Processes Yield and Capacity Improvement. Root Cause Analysis for OOS/OOT and Identification of appropriate CAPA Preparation of Investigation Reports. Process Hazard Analysis and Hazop studies preparation. Selection of Equipment Documentation related to Process Engineering activities like PFD, P&ID, Hazop, FMEA etc.. B. Tech , Chemical Engineering

Key Roles & Responsibilities: 1. Oversee and support the overall activities during the product development life cycle from quality perspective in R&D (API and intermediates). 2. To understand the site needs with respect to system establishment and sustainability. 3. Author/ Review and approve the SOPs/work directions required for implementing the Quality systems in R&D activities as per GLP and regulatory requirements. Ensure effective implementation of SOPs/ work directions. 4. Review and approve Lab Familiarization Reports (LFR), Product development reports (PDR), Technology transfer, product specifications & STPs, analytical method validation, method transfer, qualification, calibration, process validation protocol and reports. Ensure effective execution of these activities. 5. Periodic audits of R&D laboratory. Ensure online documentation and review lab notebooks, PDR/LFR documents, analytical documents and stability data. 6. Effective maintenance of R&D records, distribution and archival systems. 7. Perform cGMP audit of R&D facilities and operations. Assist the team in auditing contract manufacturers/ vendors/ contract testing laboratory. 8. Ensure R&D team is trained for their relevant job function and GMP/ GLP training. 9. Provide quality related inputs to new projects, existing project, up gradations etc. 10. Participate in identification of key starting material (KSM)/ registered starting material (RSM) and ensure that it is correctly identified. 11. Participate in handling of OOS, OOT, Deviations, Batch failures, investigations and CAPA implementation at site. 12. Establish raw material standards by studying manufacturing/ R&D requirements-conferring with suppliers. 13. Responsible to follow the safety and environmental procedures deployed in the site. Graduation and above in Science / Pharmacy

Job Description Performing In-process Checks at different stages of manufacturing and packing stages for various products during validation activity and ensuring the compliance. Preparation, execution and compilation of process validation (Process performance qualification) and cleaning validation & cleaning verification. Review of master batch manufacturing record and batch packing record in SAP. Active participation in execution of qualification and calibration activity. Ensure the compliance of the SOPs and cGMP requirements in Qualification and validation. Ensuring the compliance of the SOPs and cGMP requirements at shop floor. Work Experience 2 to 4 years Education Graduation in Pharmacy Masters in Chemistry Competencies

Hi, We are hiring for ITES Company for Validation Associate Role. Job description ***Minimum 3 years as Validation Associate is required.*** 1. Data validation test script creation: Create necessary validation scenarios needed to ensure checks are functioning as required and document scenarios in the Data Validation Specification(DVS). Document expected results for each testing scenario. Feedback to the clinical Data Scientist (CDS) any ambiguities in logic that require clarification for testing scenario creation. 2. Data validation test script execution: Entry of test data as specified in each testing scenario Compare the result obtained through entry of the test data to the expected result. Re-execute all checks that do not pass to ensure they are actual failure. Document validation failures. For validation failures due to incorrect testing scenarios, update DVS and re-execute testing scenario. Re-execute and document within the DVS validation results for checks that required programming updates. 3. Validation of the SI data set creation process: Enter data into all study visits and forms. Extract data from InForm into SI datasets Generate list of data within InForm Generate list of data contained within SI datasets Compare InForm listing to the SI dataset listing. Document unexpected inconsistencies between listing. Review time slicing specification against the SI data sets to ensure time slicing variables are being accurately populated. Document incorrect/unexpected time slicing variable assignments. Compare the pre-defined variable values as specified in the DVS against the SI data sets. Document inconsistencies To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 171 b) To Apply for above Job Role ( Pune ) Type : Job Code # 172 c) To Apply for above Job Role ( Indore ) Type : Job Code # 174

Job Description 1 Master & Control of all documents like SOPs, BMR, Specification & MOA, logbooks, calibration records to concern departments. 2 Issuance of all documents like SOPs, BMR, Specification & MOA, logbooks ,calibration records to concern departments 3 Preparation of all documents like SOPs, BMR, Specification & MOA, logbooks, calibration records of concern departments 4 Reviewing of HPTLC, TLC, GC reports, peaks, graphs etc 5 Checking & signing of BMR of Liquid syrup, Tablets & Mother tincture section. 6 Receipt & storage of executed documents like BMR, Analytical logbooks, calibration records etc. 7 Receipt & storage of control samples of finished product, raw material etc. 8 Receipt, storage & destruction of superseded SOPs. 9 Preparation of process validation protocol & Report. 10 Receipt & storage of executed validation protocol & Report 11 Receipt & storage of executed Qualification documents of equipment & instruments 12 Stability studies documentation with help of Quality control. 13 Preparation & Revision of SOPs of Quality Assurance department. 14 Compliance and preparation of Audit Report. 15 Maintenance of control sample room & Documentation room. 16 Training of sub ordinates & evaluation. 17 Preparation of Training schedule and its implementation and monitoring. 18 Identification of training needs to internal/ external to the sub ordinates. 19 Compliance of Audit Report from Government authorities (FDA). 20 Any other activity assigned by the management.

Job Summary : As a Quality Assurance (QA) professional with a qualification in MSc Chemistry, the primary role revolves around ensuring adherence to established quality and regulatory standards. The responsibilities cover a wide range of quality-related tasks, documentation management, and process validation activities in alignment with ISO and cGMP standards. Key Responsibilities: 1 Review and Implementation of ISO 9001 standards, Quality Management System Compliance, cGMP standards, ISO 14001, Halal & HACCP standards 2 Preparation of Certificate of Analysis, Good Receiving Note and other related documents in process QA checks. 3 Review of Purchase order coordination for dispatch activities 4 To ensure the dispatch activities and clearance 5 Coordination for finished products 6 To verify the LMR, BPR and analytical records 7 Preparation of cleaning validation protocols and reports 8 Prepartion of process validation protocols and reports 9 Preparation/revision of MFR for all new existing products based on changes 10 Review and approval of Lot Manufacturing Record and Batch Packing Record 11 Preparation of blending protocols and reports 12 Document Management Control

Software Engineering Lead Analyst - HIH - Evernorth ABOUT EVERNORTH: Evernorthexists to elevate health for all, because we believe health is the starting point for human potential and progress. As champions for affordable, predictable, and simple health care,we solve the problems others don’t, won’t or can’t. Software Engineering Lead Analyst – SAP Integration Suite Position Overview We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position is right for you, we encourage you to apply! Our people make all the difference in our success. This area within Evernorth is a wholesale pharmaceutical distributor that provides customized business solutions and access to specialty drugs to community physicians, specialty pharmacies, and health systems. As a senior Engineer, you will maintain delivery objectives, timelines, and high standards. You will be supporting SAP Integration Suite and ensure you work well within the team. Additionally, the ideal candidate will have strong knowledge in supply chain and distribution management along with an understanding of EDI and SAP CPI. Responsibilities Support the full software lifecycle of design, development, testing, and support for technical delivery. Be hands-on in the design and development of robust solutions to hard problems, while considering scale, security, reliability, and cost Support other product delivery partners in the successful build, test, and release of solutions. Works with both onsite and offshore team members in properly defining testable scenarios based on requirements/acceptance criteria. Be part of a fast-moving team, working with the latest tools and open-source technologies Work on a development team using agile methodologies. Understand the Business and the Application Architecture End to End Solve problems by crafting software solutions using maintainable and modular code. Participate in daily team standup meetings where youll give and receive updates on the current backlog and challenges. Participate in code reviews. Ensure code quality and Deliverables. Provide Impact analysis for new requirements or changes. Responsible for low level design with the team Maximize the efficiency (operational, performance, and cost) of the application assets. Required Experience / Qualifications Proficient in SAP Integration Suite, with a strong understanding of its components including SAP Cloud Platform Integration (CPI) and SAP API Management. Extensive experience with Electronic Data Interchange (EDI) standards such as X12, and XML. Proficiency in designing, mapping, and managing various EDI transactions like 850, 855, 810, 812, 856, 844, 845, 849, 852, 867, 832, 816, 997. Strong programming skills in languages commonly used for integration such as Java, JavaScript, Groovy, and XML. Ability to develop custom integration flows and adapters. Experience in integrating SAP systems (SAP ECC, S/4HANA) with external systems, third-party applications, and trading partners. Familiarity with IDocs, BAPIs, RFCs, and Web Services. Hands-on experience with middleware platforms, particularly SAP CPI, and their integration with SAP Integration Suite. Expertise in data mapping, transformation, and validation processes. Ability to create and manage complex mapping scenarios. Strong analytical and problem-solving skills to troubleshoot and resolve integration issues effectively. Excellent communication skills, both written and verbal, with the ability to work collaboratively with cross-functional teams, business stakeholders, and external partners. Conduct code reviews and mentoring for more junior resources. Ability to manage development individually, and multi-tasking, work with cross business teams/IT areas. Ability to look at big picture without losing sight of details. Understanding of IT, and release/delivery using CI/CD pipelines. Adaptability to work in a fast-paced and dynamic environment. Attention to detail to ensure high-quality software deliverables. Time management skills to prioritize tasks and meet project deadlines. Required Experience & Education: 5-8 years of professional work experience in technology industry Experienced with EDI Managed development in life Sciences and/or Distribution Bachelor’s degree or equivalent in Computers, Information Technology, or related field or the equivalence of education and experience Proven experience with architecture, design, and development of large-scale enterprise application solutions. Desired Experience / Qualifications: Experience in pharma industry. Location & Hours of Work Full-time position, working 40 hours per week. Expected overlap with US hours as appropriate Primarily based in the Innovation Hub in Hyderabad, India in a hybrid working model (3 days WFO and 2 days WAH Equal Opportunity Statement Evernorth is an Equal Opportunity Employer actively encouraging and supporting organization-wide involvement of staff in diversity, equity, and inclusion efforts to educate, inform and advance both internal practices and external work with diverse client populations. About Evernorth Health Services Evernorth Health Services, a division of The Cigna Group, creates pharmacy, care and benefit solutions to improve health and increase vitality. We relentlessly innovate to make the prediction, prevention and treatment of illness and disease more accessible to millions of people. Join us in driving growth and improving lives.

Kaliberr bioscience pvt ltd is looking for QA Executive to join our dynamic team and embark on a rewarding career journey You will also be responsible for identifying and resolving quality-related issues and ensuring that the company's products and services meet the requirements of customers Conduct regular quality audits to identify and resolve quality-related issues Develop and maintain quality metrics to track performance and identify areas for improvement Manage the documentation process for quality assurance procedures, including the creation and maintenance of standard operating procedures (SOPs)

Knowledge of Process development for APIs and intermediates/Trouble shooting of products at plant level/Planning and executing the experiments/Technology transfer to plant level/Handling reactions from mg to gram scale/ API R&D Required Candidate profile Cost reduction and plant troubleshooting/OD at plant site for technology transfer as & when required/ Chemistry/Regulatory Guidelines/GMP/GLP/ Timely delivery/ Compound interpretation NMR/LCMS/HPLC

Carry out solar resource assessment for various available resources based on the Project location Analysis of Energy Yield Numbers for various scenarios with different technology and optimizing the Plant Layout. Providing BOQ for the Project based on the AC & DC Cable Loss Calculation, Optimized Scenario. Evaluation of Module technology based on the documentation received from Module OEMs. Evaluation of Robotic Cleaning Solution technology based on the documentation received from Module OEMs. Plan Module Factory Visits for Inspection of the Module Manufacturing Process. Contribution to interface with Lender's Engineer and support Lenders due diligence. Working along with O&M Team to perform EL and FTR for the evaluation the health of the installed modules. Thorough understanding of ISO 2859 AQL Criteria for sample selection of modules for EL & Visual tests. Preparation of SOPs and Checklists for the methodology followed for various processes. Understanding the tests performed on modules. Understanding the test results and taking appropriate decision in selection of modules.

To follow safety rules in the premises according to the company norms. Responsible for Dispensing, checking and receiving of PPM from warehouse on need basis. Responsible for operation Maintenance and cleaning of External washing and Vial washing & Depyrogenation tunnel areas. Operation and cleaning of glove integrity and filter integrity testers. Responsible to perform the in process checks during operation. Responsible for Decartoning activity. Responsible for monthly frequency activity. Responsible for line clearance before start of the Activity. Preparation and periodic revision of SOPs related to respective area. Monitoring of DP, RH and temperature area in their respective area. To maintain the BMRs and other log books in respective area as per cGMP and SOP. Responsible for timely completion of calibrations and validations in coordination with Eng. and QA related to respective areas. Responsible for the Operation and cleaning of Automatic visual inspection. Responsible to perform visual inspection of the products /media filled vials as per the sop. Operation and cleaning lux mater, visual inspection table. Operation and cleaning of glove integrity and filter integrity testers Preparation, filtration and issuance of disinfectant and deactivation solutions to all the sections in the production area. Responsible for cleaning and storage of all the filling machine accessories and change parts Operation and cleaning of table mounted LAF and Ceiling mounted LAF Operation and cleaning of steam sterilizer and HPHV steam sterilizer. Preparation of loads meant for Autoclaving like garments, disinfectant, filling, filtration, rubber stopper and seals for sterilization as per the validated load pattern. Responsible for ensuring garments washing, drying and folding activities Timely completion of SOPs Training and On the job trainings related to respective area. Responsible for Maintenance of cleaning in in External washing and vial washing area & Depyrogenation tunnel areas and f Component preparation and sterilization area. Cleaning and sanitization of drain points in External washing and Vial washing & Depyrogenation tunnel areas and f Component preparation and sterilization area Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HODs instructions and guidance.

Responsibilities: * Ensure compliance with regulatory requirements through quality control measures * Conduct process validations, cleaning verifications & change controls * Prepare validation protocols & reports

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. Handling Support of Trouble shooting batches for data comparison and route cause Investigation at Sun/CMO. Investigation for product trouble shooting 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 ie 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 ie Production, NPQC, QA, QE (Engineering) and warehouse for smooth running of Scale up, Exhibit, Process validation batches. To ensure the compliance of various in-process control instructions provided in MF, FMEA, RA, BMR, and MBMR.

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. Handling Support of Trouble shooting batches for data comparison and route cause Investigation at Sun/CMO. Investigation for product trouble shooting 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 ie 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 ie Production, NPQC, QA, QE (Engineering) and warehouse for smooth running of Scale up, Exhibit, Process validation batches. To ensure the compliance of various in-process control instructions provided in MF, FMEA, RA, BMR, and MBMR.

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. Handling Support of Trouble shooting batches for data comparison and route cause Investigation at Sun/CMO. Investigation for product trouble shooting 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 ie 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 ie Production, NPQC, QA, QE (Engineering) and warehouse for smooth running of Scale up, Exhibit, Process validation batches. To ensure the compliance of various in-process control instructions provided in MF, FMEA, RA, BMR, and MBMR.

Ensure scientific assessmentinto the Manufacturability of the product for a robust process developmentduring new product introductions, product site transfers and processvalidation. Technical Support during process optimization activities related to ProductTransfer ProcessValidations. Technical input andknowledge sharing with team and Cross functional team (CFT). Root Cause Analysis, Statistical evaluationsand Trouble Shooting of existing commercial as well as site transfer products. Improving process capabilities, yields androbustness. Prepare, Review and Approval of technical documents like MFR, PORM, BMR,BPR, Risk assessment , protocols and reports for Trial batch, Hold timestudy, Stability study, Process validation, Exhibit or submission batchdocumentation, alternate vendor development and side transfer project. Support documentation teamin order to deliver end to end documents from development batches (exhibit) tocommercial lifecycle management. Q

03 - 06 years experience of external preparations, Ointment and OSD IPQA activities Job Responsibilities - - Totrack batches for process validation, packing validation and hold time study. Certificationof Appropriate and timely Line-Clearance for Manufacturing, Packing, Dispensing Tocarry out the online checks& to take on line SAP entries. - ToWithdraw & Submit the Samples (Analysis SFG and FG & Control samples,Validation, Regulatory, R&D, Hold time study & Micro samples) toConcern Dept. as & when required. - Toensure the cGMP on the shop floor and to highlightthe on line Problems / Non Conformances with the respect to Procedures,Specifications, SOPs, cGMP etc. on day to day basis Numbers ofcritical/major nonconformance noticed. OnlineBPR, Logbooks completion & Review of documents like Preventive calibrationrecords, daily/weekly quarantineregister etc. in the Concerned dept. - Issuanceof Batch Manufacturing Records and Batch Packing Records to productiondepartment. - Reviewof Executed Batch Manufacturing Records and Batch Packing Records Toverify online finished goods before transfer to BSR.

As an Order Management Specialist, you will handle customer order intake, ensuring accurate product ordering (HW, SW, services) and initiating tasks like purchase orders, sales orders, invoices, and delivery notes. You will support procurement, distribution, invoice validation, and cash collection, resolving disputes when needed. Additionally, you will provide informal guidance to new team members. You have: 6+ years of relevant experience. Strong understanding of customer order intake and validation processes for hardware (HW), software (SW), and services. Proficiency in managing purchase orders, sales orders, invoices, delivery notes, and letters of credit. Experience coordinating procurement and distribution processes, including demand capture, purchasing, goods receipt, and freight cost verification. Ability to monitor and ensure timely completion of transaction-related tasks. Excellent problem-solving and conflict resolution skills for handling customer disputes effectively. It would be nice if you also had: Skilled in validating customer invoices and supporting cash collection, including managing remittances and resolving disputes. Strong communication skills for liaising with internal teams, customers, and suppliers. Ability to provide guidance and support to new team members, ensuring adherence to procedures and task execution. Coordinate and validate customer order intake. Manage ordering of products (HW, SW, and services). Trigger task creation for transactions like purchase orders, sales orders, and invoices, ensuring timely completion. Support procurement execution, including demand capture, purchasing, goods receipt, and invoice verification. Assist in distribution execution by planning transportation and verifying freight costs and invoices. Help coordinate and validate customer invoices. Support the cash collection process, including managing documentary remittances and resolving disputes. Provide informal guidance to new team members on procedures and tasks.

Dear Candidates, Greetings from KEYBIZ DASHBOARDS, We are looking for Quality Assurance Executive & Sr.Executive injectables&OSD for one of our reputed pharmaceutical client, based at Hyderabad & Vizag location. Please find below openings list. 1.IPQA 2.QMS 3.AQA 4.Validation 5.Equipment Qualification 6.CSV 7.Market Complaints. The above positions we are looking for Hyderabad & Vizag locations, interested please share us updated cv to prasanthi@mydashboards.in or feel free to call on 6305391924 Thanks and Regards Prasanthi - Dashboards Team HR

Preferred candidate profile Year of experience : 4 - 6 yrs Must have exposure on Review of documents MFR, BMR, BPR, QC specification, process validation data, stability summary report. Having exposure in licensing, Knowledge of GMP & GDP. Candidate must have exposure in regulatory market. Interested candidate may share resume at hr.plant@zuventus.com

Ensuring annual budget plan adherence of all administrative related services to the entire factory Ensuring availability of infrastructure related services like workstation, computer/ laptop, intercom, mobile connection, etc. to all employees Ensuring adherence to norms and policies in terms of new joining facilities like payment for shifting, allotment of car with respect to companys car policies, etc Ensuring smooth joining process of new employee by providing him/her all the services entitled to him according to his grade and the policy Ensuring proper management of travel related services to all employees in terms of local taxi, flight, bus, train, hotel, guest house bookings, etc Ensuring proper colony management, housekeeping, horticulture, and maintenance of other facilities like wash rooms, cabins, halls, discussion rooms, etc Adherence to and Implementation of OHSAS , Sustainability, ESOPS and EMS Guidelines and Principles and Preparation and Maintenance of all necessary documents Critical Skills Sets : Application Knowledge of Sales, Service and Marketing processes Quality Core Tools - SPC, FMEA, MSA, APQP, PPAP and Process Validation etc. Application knowledge of QC Tools and Basic Statistics as well as advanced statistical tools and techniques Standardization (DWM, System Development and Policy Management) Business Lean Auditing and Assessment Skills (Preferably an IMS Auditor) Data Analytics and Business Tools Learning Enabler (Training Management, Influencing and Facilitation Skills) Good Communication and Presentation Skills and ability to work across hierarchies Experience 5 to 8 yrs. Industry Preferred Qualifications Graduation General Requirements

Candidate should have experience on activities listed below but not limited to Scale up of process from Lab to Pilot to Commercial. Process validation of new molecules for regulatory filings Process validation of Cost Improvement Processes Yield and Capacity Improvement. Root Cause Analysis for OOS/OOT and Identification of appropriate CAPA Preparation of Investigation Reports. Process Hazard Analysis and Hazop studies preparation. Selection of Equipment Documentation related to Process Engineering activities like PFD, PID, Hazop, FMEA etc. . B. Tech , Chemical Engineering

Instrument Handling - pH Meter, Analytical Balance, Friability Tester, Disintegration Apparatus, Hot Air Oven, Moisture Balance, UV Sprct. Raw & Packing Material Testing Strong GLP Adherence Robust GMP Documentation Regulatory Compliance Awareness Required Candidate profile Experience: 2–3 years in pharmaceutical Quality Control Strong knowledge of analytical instruments and QC procedures Soft Skills: Detail-oriented, organized, good interpersonal & communication skills