Get alerts for new jobs matching your selected skills, preferred locations, and experience range. Manage Job Alerts
3.0 - 8.0 years
8 - 12 Lacs
Bengaluru
Work from Office
Educational Master Of Technology,Bachelor Of Science,Bachelor Of Technology,Bachelor of Engineering,Bachelor of Pharmacy (Honors),Master of Pharmacy Service Line Application Development and Maintenance Responsibilities Key components of the responsibilities are as mentioned below but not limited to:6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA, DD, IQ, OQ, PQ’s, TRM.Assure compliance with GxP (GMP, GCP, GLP) & privacy requirements. Develops and maintains IT GxP compliance documentation.Ensure GxP Computerized Systems are validated as per GAMP -5 requirements.Stakeholder management and good executor with required communication.Candidate must have fair conceptual understanding on below key areasoIT QMSoValidation/QualificationoRisk management. oHandling of defects/Deviations oInvestigations oCAPA Handling oTest Management & Compliance Candidate must have understating on latest regulations i.e. 21CFR Part 11, EU annex 11, and Guidelines e.g. GAMP5 guide.Candidate will provide an application validation expertise practically on different scenarios as applicable case to case i.e., standalone/enterprise etc. Technical and Professional : Hands-on experience on testing tools like HP ALM, Kneat and SNOW-Experience to MES, QMS (Trackwise), Lab solutions i.e. LIMS, Empower CDS, Chromeleon, Business Analytics, Middle wares etc. will be an advantage -OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus)-PAS/DCS Qualification -ISA95 High level of understanding -OT Security will be a plus.-Standalone Systems Qualifications-PAS/DCS Integrated with Manufacturing Equipment qualification. Preferred Skills: LS Domain-Computer System Validation (CSV)
Posted 1 month ago
2.0 - 5.0 years
7 - 11 Lacs
Noida
Work from Office
Key requirements for this role are as follows: Excellent Communication skills Stakeholder comms Progress updates Comms related to Risk/Issue Outstanding Planning skills (using Agile/SAFe) Scope Clarity and Goal Setting Art of breaking down the work Estimation Work Allocation Risk and Dependency Management Strong Tracking and Monitoring Tracking progress Identifying and Raising Risks Behaviours Accountability/Ownership demonstrated Ability to work cohesively with people/teams Domain Should have preferably worked in Capital Markets Mandatory Competencies Agile - Agile FS Domain - Capital Market Beh - Communication
Posted 1 month ago
5.0 - 10.0 years
5 - 9 Lacs
Bengaluru
Work from Office
Immediate Openings on CSV Analyst _Bangalore Experience : 5+ Skill:- CSV Analyst Location : Bangalore Notice Period :- Immediate . Employment Type: Contract . Job Description: Key Skills: - Application/Product development testing and experience in Computer Systems Validation (CSV) - Experience in QMS, Regulatory Requirements, GxP Compliance, and Good Documentation Practices - Strictly adhereing to Business SOPs, cost & coverage, requirement specifications & formulation of Test Cases in HP ALM for the Functional, Integration, end-to-end, Usability, and smoke testing. - Experience in the development of Qualification test scripts (IQ,OQ, PQ and VSR) for CSV projects - Good knowledge of CSV, GAMP5, 21CFR Part 11, and good documentation practices - Knowledge on HP ALM and Jira Tool and validation approval process using ALM
Posted 1 month ago
3.0 - 6.0 years
8 - 12 Lacs
Gurugram
Work from Office
Job Overview: We are seeking experienced research professional to join Oliver Wyman s Knowledge D epartment . You will work closely with partners and consultants in the Financial Services practice s with focus on the Banking and Financial Services sector to gain insights to support business development and project delivery. The Knowledge D epartment supports our consultants with planning and execution of on-demand research projects as well as the interpretation, evaluation, and preparation of results . You will be helping consultants to scope and develop their research needs, conduct timely , accurate and cost-effective research for focused needs, deliver compelling synthesized end products. Y ou will work with a wide range of information tools and proprietary databases to provide research for client projects and business development. The role requires the ability to develop strong relationship s with practice members and help consultants to scope and develop their research needs , conduct timely, accurate and cost-effective research for focused needs, deliver compelling synthesized end products , and w ork within the framework of the European based team, sharing work and experience and helping build the research function in the region . Key Responsibilities Work with a wide range of information tools and proprietary databases, providing both quick solutions and in-depth research for the business. Be able to think critically and develop the most efficient solutions Synthesize information and glean key concepts and trends from the information, provide own point of view and basic insights in the deliverables. Collaborate with global research teamengaged in client service, business development or intellectual capital building by delivering highly relevant and well-synthesized research. Directly engage in strategic projects, together with our research specialists and consultants, contribute to updates and maintenance of customized knowledge products Build expertise in Financial Services sector topics and master tools and resources to support your data analysis. Develop strong trusted relationships with the practice members and research colleagues to promote effective knowledge sharing and positive work environment. Independently manage the pipeline of industry-specific tasks, set priorities, and collaborate with a team of international colleagues to meet client demands. You will be required to exercise independent judgment to solve internal client demands. This will involve prioritizing your own work to satisfy competing needs and building excellent task management and time management skills Use MS Office tools to produce graphical portrayal of research findings, customized to project needs Experience and Skills Required At least3-5years experience of working in banking or capital markets sectors, providing business informationand conducting analysis. Relevant experience in professional consulting firms is an advantage. Experience of working with specialized data sources is essential. For example:Factiva, Capital IQ, Refinitiv, Bloombergand otherdatabases. Growth mindset and high-quality work standards, willing to continuously improve your skills to enhance service to our clients. Excellent communication skills and research synthesis skills allowing you to draw out key insights and to provide basic data analysis. Team player who has experience of and has enjoyed working as part of a team. We look for enthusiastic, collaborative, and flexible team members who are able to empathize with clients and peers. Excellent Excel skills. Proficiency with rest of MS Office suite. Experience with Power BI is an advantage. What we can offer you A stimulating working environment that provides opportunities for professional growth, access to mentoring and training programs Attractive compensation package and selection of benefits Working in diverse and dynamic team environment. Friendly and flexible workplace that promotes work-life balance. Fresh fruit, beverages and snacks A range of digital collaboration and online communication tools to support effective team work Various social initiatives and learning opportunities adapted for virtual settings
Posted 1 month ago
3.0 - 7.0 years
4 - 5 Lacs
Pune
Work from Office
EXIM: • Manage documentation retention of all commercial documents for North America shipments. • Follow up for missing documents from all vendors in a timely manner to prevent logistics delays. • Goods Receipt of 3rd party invoices in SAP • Verification of commercial invoices as per US Customs entries • Export Planning & operation. Sales order-Purchase Order • Support Sales by managing customer orders, creation of Sales order-Purchase order (SOPO). • Coordination with Sales team, inventory team & Planning team to analyze & place order as per business requirement. • Support marketing in implementing customer complaints resolution. • Creating Standard reports on Open Orders, closed order & Inventory availability and posting transactions on SAP. • Resolving the issues with sales order/Purchase order to make smooth shipment. • Checking the Import/Export custom document (shipment detail, CTH, duties etc.) of North America shipment & maintain the data. • Highlight the concern in EXIM document for resolution & work for solution as well. Customer Services: • Support Sales by managing customer orders, document creation, logistics planning and execution, shipment tracking, returns management. • Creating Standard reports on Open Orders, Inventory availability and posting transactions on SAP • Create Sales Contracts and liaison with Sales / Finance to create sales contracts / orders. • Create Documentation, co-ordinate with logistics and warehouse, track shipment and inform customer for sales orders. • Assist Key Account Managers in allocation of shortage material and create dispatches as per allocation. • Create standard reports on Inventory, open order status for the perusal of planning and sales team. • Create return orders, documentation, co-ordinate with logistics and warehouse for all customer returns. Toller: • Shipment transaction like STO (Stock transfer), Production posting, BOL creation, PGI & PGR for stock etc. • Analysis of stock and input from UPL NAM warehouse & third party and process the transaction in SAP. Other activities • Support to any other Logistics function. • Work on Improvement projects & process streamline. • MIS & Data mining and initiative for improvement within system & process. • Excellent in IQ & coordination with stakeholder to resolve the error/problem. Strong Organizational Skills • Strong Follow-up Skills • SAP and intermediate Excel • Written and Verbal Communication Skills • International Logistics Experience a plus Preferred Sectors for sourcing the talent – Manufacturing. Resource needs to work in Global region shift as per country time zone. English communication is must & comfortable to work in regional shift time. Logistics/EXIM knowledge is required. Education - bachelor’s degree/MBA in SCM or IB. Experience - 3 to 6 years Preferred location from Pune /Nearby Pune.
Posted 1 month ago
5.0 - 8.0 years
7 - 10 Lacs
Medak, Telangana
Work from Office
The Senior Executive QA (Engineering Assurance) will be responsible for executing and reviewing qualification lifecycle documents for GMP equipment, utilities, and facilities. The role includes oversight of URS, DQ, IQ, OQ, and PQ protocols, engineering change controls, risk assessments (FMEA), and periodic requalification activities. This position works closely with Engineering, Validation, Projects, and cross-functional QA teams to ensure timely qualification and regulatory readiness. Key Responsibilities: QA review and approval of qualification protocols and reports (URS, DQ, IQ, OQ, PQ) Oversight on facility, utility, and equipment qualification activities QA support for engineering change controls and deviation handling Risk assessment and mitigation using tools like FMEA and HAZOP Periodic review and requalification planning Participation in internal/external audits and regulatory inspections Ensuring data integrity and documentation compliance across qualification records Responsibilities Qualifications B.Tech / M.Tech / B.Pharm / M.Pharm / M.Sc. with specialization in Engineering, Life Sciences, or related field 5-8 years of relevant experience in QA Engineering or Qualification/Validation domain Strong knowledge of GMP regulations (USFDA, MHRA, EU) and qualification standards (ISPE, WHO, ICH Q9, Q10) Hands-on experience in equipment/facility qualification, HVAC, water systems, and cleanroom validations Excellent documentation review, risk assessment, and communication skills
Posted 1 month ago
8.0 - 13.0 years
10 - 20 Lacs
Hyderabad
Hybrid
Employment Type: Contract Working Mode : Hybrid 12+ years of experience working in electronic based Computer System Validation in a GxP environment Demonstrated ability to maintain a CSV and Computer and Instrument System Change Control process Experience in employing risk-based approaches to CSV Experience in qualification of GLP Instrument Systems Ability to provide Quality oversight during implementation of GxP Software as a Service tools and systems Experience in perform
Posted 1 month ago
3.0 - 5.0 years
5 - 7 Lacs
Gurugram
Work from Office
Company: Oliver Wyman Description: We are seeking experienced research professional to join the Oliver Wyman Knowledge department. The professional will work closely with partners and consultants in the India, Middle East & Africa (IMEA) Region on the Transportation & Services team in areas such as: aerospace & defense, aviation, rail, postal, logistics, travel and leisure. The global Knowledge Services Research Team supports our consultants by sourcing and synthesizing market data, industry developments and company information necessary for the successful execution of client projects and business development initiatives. Key Responsibilities: Conduct in-depth research, producing synthesized analysis providing own point of view and expert insights in the deliverables Work with a wide range of information tools and proprietary databases, providing both quick solutions and in-depth research for the business. Be able to think critically and develop the most efficient research strategies to solve complex client requirements Produce graphical portrayal of research findings - compiling research results into a presentation and/or formatting into desired format, customized to project needs Independently manage the pipeline of industry-specific tasks, set priorities, and collaborate with a team of international colleagues to meet client demands. You will be required to exercise independent judgment to solve internal client demands. This will involve prioritizing your own work to satisfy competing needs and building excellent task management and time management skills Collaborate with consultants engaged in client service, business development or intellectual capital building by delivering highly relevant and well-synthesized research. Directly engage in strategic projects, together with our research specialists and consultants, contribute to updates and maintenance of customized knowledge products Building expertise in the IMEA related industry topics and resources to support data analysis Develop strong trusted relationships with IMEA practice members and work within the framework of the Dubai based research team dedicated to IMEA, sharing work and experience and helping to build the research function in the region Use MS Office tools to produce graphical portrayal of research findings, customized to project needs Produce curated newsletters (advanced, and automated where possible) and provide support and sometimes take a lead for internal research projects Experience and Skills required: We require a graduate degree with at least 3 to 5 years of research experience in transportation, especially in any of the following sectors: aviation, maritime, surface transport and logistics - - preferably in management consulting or research firm Knowledge of India and Middle East business and economic context Excellent English skills proficiency in Arabic language a plus Knowledge of general resources such as Eikon, Cap IQ or Factiva and industry specific resources such as IATA, BMI Fitch. Excellent knowledge of the Microsoft Office suite (Excel, PowerPoint, Word, Outlook) Excellent research synthesis skills with ability draw key insights from data and to provide basic analysis of findings What we can offer: Full time job contract with an attractive compensation package (including year-end financial bonus) Attractive compensation package and selection of benefits A stimulating working environment that provides opportunities for professional growth, access to mentoring and training programs Inclusive culture with Employee Resources Groups and CSR activities Working in diverse and dynamic teams, friendly and flexible workplace that promotes work-life balance.
Posted 1 month ago
1.0 - 5.0 years
6 - 10 Lacs
Jaipur
Work from Office
: Job TitleLoan Operations Senior Analyst LocationJaipur, India Role Description PB Lending Operations (Banking) team is part of Wealth management Operations which takes care of Loan Payments, receivables, Invoice Generations, Auto debit setup, Loan reporting, Collateral bookings and reconciliations for Private clients. What well offer you 100% reimbursement under child care assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Accident and Term life Insurance Shift Allowance Your key responsibilities Deal Origination/Account set upDeal building for bilateral and Agented deal in Loan IQ system, Credit agreement documents validation, deal closing with Initial Funding, Upfront Fee, Amortization, Funding, MFF, MCF and MGL. Amendment document validation and processing in Loan IQ system. Reallocation Notice review and processing in Loan IQ system Managing email box and processing funding requests on already set up loans in system. Adjustments of Interest rates in Deposit account when required. Managing email box and processing funding requests on already set up loans in system. Adjustments of Interest rates in Deposit account when required. Preparing of automated and manual reports on outstanding Documents and sharing with business, Keeping a track of outstanding document on loan account. Following up with business for submission. Identifying a business risk and report it to respective stakeholders. Prepare an action plan to mitigate risk and close the outstanding risk items withing deadlines. Handling Audits requirements with explaining the process and providing documents Training new staff and keeping documents updated to process and Audit requirement. Your skills and experience Experience in Lending Operations is required Working hands on knowledge of Loan IQ application is must. Must understand U.S. based Lending products Needs to be a self-starter with significant ability to undertake initiatives. Strong interpersonal / good negotiations skills are required. Follow through skills, Effective communication skills, fluency in Microsoft Office skills, ability to confidently handle internal clients, futuristic and innovative approach will be expected. Ability and willingness to work in night shift is a must. How well support you A culture of continuous learning to said progression About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.
Posted 1 month ago
5.0 - 8.0 years
7 - 10 Lacs
Bengaluru
Work from Office
SAP FI - Treasury Risk and Cash Liquidity Mgmt - Expert proficiency in SAP FI Treasury - Ability to read through the customer business processes and simultaneously formulating the adoption of the best business practices in meeting the foreseeable challenges Ability to review, validate the right set of questions Create solution workshops with senior business managers, review validate solutionproposals and estimates, rendering advice on best business practices and getting the buy in to adopt these practices Ability to create solution road maps integrating multiple disparate processes Ability to present and get the buy in forthe solution from senior managers Implement the solution by leading the team In addition to leveraging the standard processes, come out with innovative solutions and timely execution of the project within the agreed time lines Do: Implement deployment quality strategy for the assigned Accounts Provide inputs in the development of strategy for the assigned accounts while considering the quality standards, client expectations, quality, and monitoring mechanisms Review and reallocate the priorities to align with the overall strategy of the line of business / business unit Quality control and Customer satisfaction Support the completion of Annual Customer Satisfaction survey by ensuring completion of survey by the account customers, representatives for various projects within the account. Ensure completion of survey and address any queries in a timely manner. Support in conceptualizing the action planning by communicating with clients and interacting with Delivery Managers, vertical delivery heads and service delivery heads Drive the account wise tracking of action planning identified for sustained CSAT in various projects. Drive the Quarterly pulse survey for selected accounts or projects for periodic check-ins. Support the Account Leadership teams for tracking and managing client escalation for closure. Early Warnings and Business partnership Drive the implementation of mechanisms for preventing client escalations / dis-satisfactions by creating an early warning system in DigiQ covering aspects like delivery quality, delivery schedule, resources constraints, financial issues (overloading of effort / over-run potential), productivity, and slippages on milestones. Participate in Monthly and Quarterly Business review along with Business and Account leadership to ensure adherence of defined quality processes, define new life cycle models and ensure gating processes are followed the projects within the accounts. Drive the upskilling of delivery teams on quality management tools, knowledge management and create mechanisms for sharing of best practices. Support the collection of metrics on the performance / health of process and regular publishing of compliance and metrics dashboards. Continuous Improvement Drive a culture of continuous improvement in the assigned accounts to ensure enhance efficiency and productivity of resources Create mechanisms between the projects in the account for sharing knowledge, quality issues, risk mitigation methods within the accounts to drive the continuous improvement Plan and drive year on year improvement goals in various projects by way of process streamlining & improvements and automation, leading to cost savings and / or efficiency Support the collection of metrics to show the improvements- efficiency / productivity improvement. Team Management Team Management Clearly define the expectations for the team Assign goals for the team, conduct timely performance reviews and provideconstructive feedback to own direct reports Guide the team members in acquiring relevant knowledge and develop theirprofessional competence Drive geography specific trainings for the quality team, designed basis the statutory norms that apply in different countries Ensure that the Performance Nxt is followed for the entire team Employee Satisfaction and Engagement Lead and drive engagement initiatives for the tea Track team satisfaction scores and identify initiatives to build engagementwithin the team Deliver No. Performance Parameter Measure 1. Quality Control and Customer satisfaction CSAT Score-BU/Account/Portfolio level Process Compliance/Exceptions Scores Audit Coverage percentage Schedule performance Scores Planned vs actual project effort Resource productivity scores 2. Capability Building New Employee Onboarding New Employee Certifications 3. Continuous Improvement Lean projects implemented per year Productivity improvement of resources Continuous Improvement Processes implemented per year 4. Team Management Team attrition % Employee satisfaction scores 5. Capability Building % trained on domain and location specific skills, % of team trained in necessary leadership skills Mandatory Skills: SAP FS-CM Functional. Experience5-8 Years.
Posted 1 month ago
3.0 - 5.0 years
4 - 8 Lacs
Bengaluru
Work from Office
SkillSAP FI-FSCD LocationPune and Bangalore Minimum of 4 years SAP experience Configure G/L, A/P, A/R, Asset Accounting, Interface Integrations, Experience on Collections and Disbursements (FS-CD) Experience providing application support Relevant SAP certifications are a plus Do Ensure timely response of all the tickets raised by the client end user Service requests solutioning by maintaining quality parameters Act as a custodian of clients network/ server/ system/ storage/ platform/ infrastructure and other equipments to keep track of each of their proper functioning and upkeep Keep a check on the number of tickets raised (dial home/ email/ chat/ IMS), ensuring right solutioning as per the defined resolution timeframe Perform root cause analysis of the tickets raised and create an action plan to resolve the problem to ensure right client satisfaction Provide an acceptance and immediate resolution to the high priority tickets/ service Installing and configuring software/ hardware requirements based on service requests 100% adherence to timeliness as per the priority of each issue, to manage client expectations and ensure zero escalations Provide application/ user access as per client requirements and requests to ensure timely solutioning Track all the tickets from acceptance to resolution stage as per the resolution time defined by the customer Maintain timely backup of important data/ logs and management resources to ensure the solution is of acceptable quality to maintain client satisfaction Coordinate with on-site team for complex problem resolution and ensure timely client servicing Review the log which Chat BOTS gather and ensure all the service requests/ issues are resolved in a timely manner Deliver NoPerformance ParameterMeasure1.100% adherence to SLA/ timelines Multiple cases of red time Zero customer escalation Client appreciation emails Mandatory Skills: SAP FI Financial Supply Chain Management. Experience3-5 Years.
Posted 1 month ago
0.0 - 5.0 years
4 - 8 Lacs
Visakhapatnam, Hyderabad
Work from Office
Job Description The scope of work for this role is to provide QA Validation support to validation activities associated with of Laboratory instruments and Manufacturing equipment in pharmaceutical industry. The responsibility includes review and approval of Qualification/Validation documentation DQ,IQ,OQ,PQ including Risk assessment, specifications, executed protocols, summary reports, deviations, periodic reviews, procedures, and change controls. In addition, this role may provide support to the sites data integrity initiative. Successful candidate requires a strong working knowledge of global cGMP with an emphasis on validation lifecycle including computer system validation, 21 CFR Parts 210 and 211, and Part 11, Electronic Records and Electronic Signatures Candidate requires strong interpersonal, oral and written communication skills as there is a high degree of collaboration required between members of QA Validation/Qualification personnel. Candidate must be detail oriented as the main job responsibility is review and approval of validation documentation Should also have some experience in Mechanical Qualification Job Requirements Skills: Strong working knowledge of global GMPs with emphasis on validation, including computer validation Strong interpersonal, oral and written skills Detail oriented Education: Candidate must have at a minimum a BE or equivalent, engineering or related sciences with pharmaceutical or biopharmaceutical experience in a quality assurance and/or validation/Qualification role. Past experience working with Equipment Qualification, Quality Management system, Document, Document Management System, Track wise, and etc. Experience working with process manufacturing equipments (RMG, Sifter, Blender, compression m/c, Capsule filling m/c & etc), Utility (Water system, HVAC & etc) and other lab instruments is a plus.
Posted 1 month ago
5.0 - 10.0 years
5 - 9 Lacs
Ahmedabad
Work from Office
> Role Objective: A key objective of this profile is to ensure the effective planning, execution, and documentation of validation and calibration activities, in compliance with regulatory standards and internal policies. The role focuses on maintaining high-quality standards, managing internal and external audits, and ensuring adherence to ISO 13485 and other relevant quality management standards. Additionally, the role supports continuous quality improvement initiatives and ensures that validation activities align with business needs and regulatory requirements. > Desired Candidate Profile: Bachelor's or master's degree in engineering, life sciences, or a related field. A minimum of 6 years of experience in quality assurance within the medical device or pharmaceutical industry. Strong knowledge of validation processes, quality systems, and regulatory standards, such as MDD 93/42/EEC and ISO13485. Experience managing CAPA (Corrective and Preventive Action), conducting risk assessments, and handling internal/external audits. Proven ability to manage validation projects, including scheduling and team coordination. Excellent communication, organizational, and analytical skills. > Role & Responsibilities: Plan and execute validation and calibration activities according to the approved schedule, including HVAC, process, transport, sterilization, equipment qualification, and temperature mapping. Coordinate the preparation of PR, PO, material issuance, and service entries for validation-related activities. Provide training to relevant personnel on validation processes and artwork review. Review and compile validation reports from external agencies, ensuring timely approval and payment processing. Verify vendor agreements and certifications, ensuring timely renewals and regulatory compliance. Oversee and ensure the proper execution of QMS activities, including document management and software use (e.g., TrackWise). Participate in line clearance and IPQA (In-Process Quality Assurance) activities as needed. Prepare and review GMP (Good Manufacturing Practice) documents such as SOPs, protocols, and other required documents. Ensure adherence to ISO13485 standards and other relevant regulations. Collaborate with the regulatory department to provide validation and calibration documents as needed for regulatory submissions. Participate in internal and external audits, ensuring timely and accurate documentation submission. Manage PR initiation and closure in TrackWise for qualification and calibration activities. Prepare and execute equipment and utility validation documents as per schedule. > Functional Skills Required: Expertise in Quality Management Systems (QMS) and validation processes. In-depth knowledge of MDR and other relevant regulatory frameworks. Strong proficiency in CAPA management, auditing, and risk assessment. Technical expertise in process, equipment, and product validation. Ability to manage multiple validation projects and meet strict deadlines. > Behavioral Skills Required: Strong team management and leadership abilities. Excellent problem-solving and analytical skills. High attention to detail and a commitment to accuracy. Strong interpersonal and communication skills. Ability to collaborate effectively across teams and departments. A proactive approach to continuous improvement and maintaining high-quality standards. > Team Size to be Handle: Manage the team of 2-3 team members of Validation & QMS, reporting to AGM-QA. Learn more at https://www.biotechhealthcare.com. Biotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.
Posted 1 month ago
2.0 - 7.0 years
2 - 7 Lacs
Ahmedabad
Work from Office
Well experience Computer system validation (CSV) in API/formulation organisation, Preparing all validation document (i.e URS, GxP assessment & SLRA, Configuration specification, IQ, OQ, PQ, RTM, VSR, DRP) through validation tool as per GAMP 5 & 21 CFR Compliance or Manufacturing and Quality Control Laboratory Equipment. Validate newly/upgraded software in QC Laboratory/manufacturing. Preparation periodic review & Vendor Assessment for Manufacturing and Quality Control Laboratory Equipment Initiate QMS document in Manual/Software base i.e : CCF, Risk assessment, Deviation etc. Solving the issue occurred during the execution. Data Migration and System Retirement activity triggered for manufacturing system. Experience of SOP preparation Preparation of inventory list, periodic review schedule, periodic review report Designation : Executive/Senior Executive Experience: 05 - 09 years
Posted 1 month ago
10.0 - 16.0 years
8 - 18 Lacs
Jadcherla
Work from Office
Role & responsibilities Job Description: 1. Preparing and implementing of standard operating Procedures, Batch records, Protocols, cleaning procedures and relevant log sheets. 2. Maintaining documents as per regulatory and cGMP norms. 3. Handling of QMS activities, Change controls, Deviations, Incidents and risk assessments. 4. Responsible for ensuring the department employees for training as per training plan schedule in the TRIMS. 5. Responsible to attend all training programs, SOPs and cGMP trainings relevant to area and equipments. 6. Responsible for monitoring of periodic review of SOP’s related to FP Departments and ensuring the completion with in due date. 7. Performing DQ, IQ, OQ, and PQ for the equipment’s. 8. Writing of relevant Batch documents and log books. 9. Execution of production plan for formulation and filling. 10. Achieving planned FP targets with strict adherence to cGMP. 11. Execution of planned activities of Aseptic Processing Areas like media fills simulation trials, Formulation and filling activities. 12. Execution of preventive maintenance plan for equipment’s in coordination with Engineering and QA departments. 13. Performing day to day activities as per requirements. 14. Reporting all the activities, deviations and issues to Reporting officer. Preferred candidate profile ITI/ DIPLOMA/ B. TECH/ Pharmacy With Relevant experience
Posted 1 month ago
6.0 - 8.0 years
2 - 4 Lacs
Kadi, Ahmedabad
Work from Office
Experience in Vaccine/Injectable/Sterile manufacturing setup Review and evaluate facility, utility, process equipment & instrument design Prepare and review URS, DQ, FAT, SAT, IQ, OQ, PQ documents Conduct Computer System Validation (CSV) as per GAMP & 21 CFR Part 11 Coordinate with project teams to meet timelines and milestones Ensure compliance with GMP and regulatory standards Investigate deviations, failures, and non-conformances Identify root causes and implement CAPA Support audits and inspection readiness activities Job Location: Kadi, Gujarat ( Bus facility available from Ahmedabad, Kalol & Kadi) Note: Immediate joiners will be preferred first
Posted 1 month ago
3.0 - 5.0 years
4 - 5 Lacs
Hyderabad, Madhapur, Telangana
Work from Office
QUALITY ASSURANCE & VALIDATION Responsible for development, implementation, and effectiveness of quality strategies, programs and functions for all products and technical solutions to meet all corporate and regulatory objectives with respect to quality initiatives. Summary: Plans, coordinates and directs activities concerned with DDi QMS, Quality manual, compliance related activities (ICH, 21 CFR, GPDR etc), SOP management, and regulatory compliance of processes and products. Plans and coordinates the quality management program designed to ensure quality development of products consistent with established standards . Accountabilities Interfaces with customers and vendors representing company as Quality champion. Formulates and maintains quality assurance objectives complementary to corporate policies and goals. Designs and implements quality assurance training programs to key personnel in conjunction with managers. Prepares and maintains control plans and revises/audits processes, responds to customers quality concerns. Manage client and regulatory authority audits Maintains companywide Quality Management System and ISO 9001, 27001 and ISO 14155 compliance. Oversee and own SOPs for entire organization Author or Review validation documentation (plans, protocols, test suites, reports, etc.) . Contributes to project discoveries, project kickoffs, review proposals and statements of work to ensure CSV standards are represented. Coordinates client specific validation activities with practice leads. Enforce QA requirements for IT quality systems with potential GxP impact. Support GxP decisions/strategies during validation projects . Document applicable deviations and documentation anomalies for computer systems undergoing validation. Provides leadership throughout the lifecycle of a project, guiding the understanding of the validation process that the project team has through design, development, and implementation to ensure project requirements are met. Review requirements, traceability matrices, test suites and test executions . Travel involved. Other duties as assigned. KRA spread: QMS and corporate Quality management: 60% Validation: 40%
Posted 1 month ago
6.0 - 11.0 years
6 - 16 Lacs
Hyderabad
Work from Office
Role & responsibilities Job Responsibilities/Descriptions 1.0 Working / Real time experience on Digital platforms like DMS, TMS, ERP, LIMS, QMS and different application software used in production and QC. 2.0 Knowledge on 21 CFR PART 11, GAMP guidelines. 3.0 Provide expertise and guidance to the project/cross function team on computerized system validation activities to meet GxP regulatory needs with focus on Data Integrity. 4.0 To ensure computerized systems validation, and compliance throughout the life cycle of the Equipment/system to comply with the site procedures and Regulatory requirements. 5.0 Preparation of Computerized Systems Validation Master Plan and Gap assessment (if required) as and when needed. 6.0 To Identify and mitigate risks related to computerized systems at the site level. Prepare/support risk assessment documents and ensure execution of validation activities based on assessed risk. 7.0 Knowledge on computerized system inventory and GxP risk classification/ Impact Assessment. 8.0 Review and preparation of URS, FS, IQ, and OQ documents related to GxP computerized system, IS infrastructure and participate in qualification/validation or compliance verification of computerized systems. 9.0 Knowledge on Audit trail review. 10.0 Prepare/ review the computerized systems SOPs and ensure the site, GxP regulatory requirements. Preferred candidate profile
Posted 1 month ago
6.0 - 11.0 years
6 - 16 Lacs
Hyderabad
Work from Office
Role & responsibilities Job Responsibilities/Descriptions 1.0 Knowledge on Guidelines (ISPE, PDA, ICH) regulation (FDA & EMA). 2.0 Participate in Equipment, Area, Utilities and Facility qualifications. 3.0 Preparation and Review of URS, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Commissioning Studies, and SOPs related to Equipment/systems. 4.0 To monitor the Performance Qualification of various equipment and systems at site. 5.0 Review of Performance Verification protocols and reports. 6.0 To be part of process validations studies like Washing Validations, Mixing Validations, CIP and SIP validations, Filling Validations, Capping Validations, Autoclave, DHS Validations and providing support for preparation and review of summary report. 7.0 Review and verification of Calibration, Preventive Maintenance and Annual Maintenance records of equipments related to GMP Area. 8.0 Handling of Qualification related change controls, Deviation and CAPA initiation and closure. 9.0 Handling and knowledge on breakdowns, Notifications, and clearance request. 10.0 Basic knowledge on 21 CFT part 11 requirements. 11.0 Prepare/support risk assessment documents and ensure execution of validation activities based on assessed risk. Identify and mitigate risks related to computerized systems at the site level. 12.0 Preparation and review of the SOPs related Qualification, validation (Including CSV) and review of Engineering SOP. 13.0 To ensure the Audit trails and data integrity compliance for GxP computerized systems. 14.0 Reviewing and approving (or rejecting) validation or qualification protocols and or reports. 15.0 Providing Quality oversight on engineering activities. Knowledge on Preventive maintenance and Calibration. Preferred candidate profile
Posted 1 month ago
5.0 - 10.0 years
6 - 8 Lacs
Navi Mumbai
Work from Office
Purpose of the position Programming of Siemens S7 control software Testing of systems before delivery Supporting commissioning at the customers site Handling support cases and troubleshooting system-related issues Creation of Control Documents (P&ID,I/O, cable list, termination details). Role & responsibilities Advanced knowledge of Siemens S7/TIA control and WinCC Advanced/Unified/7.5 Knowledge of measurement, control and regulation technology Independent, structured, and systematic approach to work Good problem solving and analytical skills Knowledge of EPLAN and PC technology Extensive knowledge of the WAB product range Experience with GMP (Good Manufacturing Practice) Knowledge of machinery safety regulations Understanding of ATEX regulations for hazardous environments Knowledge of DQ, IQ, OQ Knowledge of SCADA will be an advantage Supporting the company electrician Preferred candidate profile Understanding process sequences and creating PLC programmers Creating visualizations with WinCC - Advanced/Unified/7.5 Parameterizing of VFDs Optimizing existing controls and processes Solving application-specific electrical customer problems Performing quality assurance tasks in accordance with the quality manual and connected documentation
Posted 1 month ago
9.0 years
8 - 12 Lacs
Hyderabad
Work from Office
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Knowledge and Experience: • Minimum of 2 years experience in quality assurance, auditing, including sound experience of applicable GxP auditing • At least 5 years’ experience in regulatory affairs, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory, or other relevant area in life science such as technology, third party supplier management. Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials and other clinical research Education: • Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience • Master’s degree in a science, technology or industry related discipline, preferred
Posted 1 month ago
1.0 - 2.0 years
7 - 11 Lacs
Mumbai
Work from Office
Joining the Mumbai office in the role of Analyst, the incumbent will be required to work closely with investment banking professionals across our global offices. Our full-time analyst program is designed to cultivate the quantitative and qualitative skills necessary to excel in an investment banking career and as a future executive. You will receive both formal and on-the-job training throughout your tenure. You will gain increasing levels of responsibility as you progress in your career, from conducting research, drafting pitch decks, building financial models, to managing business development initiatives. You will be given unparalleled exposure and opportunities, including the chance to work on numerous transactions at the start of your career. As a result, our team members achieve accelerated career growth. You will be recognized and rewarded for your individual performance within a close-knit team and meritocratic culture. The only constraint on your role, responsibilities, and compensation will be your own performance. Your Contribution As an integral member of the global advisory team, you will be challenged to accept increasing levels of responsibility as you develop your skills and reputation. Your work will directly impact our clients and the firm. Your role will include: Preparing client presentations Maintaining marketing materials for the firm, including creating pitch decks to be presented to potential clients Assisting the global team in the evaluation of investment opportunities and management of existing investments Researching potential investment banking opportunities; providing research on target companies, sectors, industries, and geographies Participating in the execution of equity and debt offerings, mergers and acquisitions, public-private partnerships, and principal investments Assisting in due diligence processes Assisting in the development of complex financial models for infrastructure transactions Acting as a subject matter expert Our Differentiators Breadth of experience and level of responsibility Exceptional level of responsibility on complex transactions Wide breadth of work across verticals, financial products, and principal opportunities Opportunities to work on large global transactions Training Continuous internal training program Internal leadership development program Opportunity to participate in onshore development programs Culture and approach Entrepreneurial culture with a flat organization structure Direct exposure to working with Partners and senior management across Agentis' international offices Compensation and employee ownership Competitive base salary Performance-based bonus Other benefits Paid sabbatical every two years of employment Comprehensive group health plan Your Skills and Experience Obtained a graduate or masters degree from a reputable university (2021-2023 graduates) 12-24 months of relevant work experience in an M&A advisory role, preferably with an MNC in a global setup Exceptional academic results (minimum cGPA of 80% or 3.7/4.0) CA/CFA is an asset Experience working with financial tools and databases including Bloomberg Terminal, S&P Capital IQ, and Inframation Ability to concisely communicate complex concepts and ideas verbally and in writing Ability to take initiative and work independently with minimal supervision Desire to assume increasing levels of responsibility and seek solutions to complex problems Committed to producing accurate and thorough work product under tight deadlines Ability to learn quickly and adapt in a fast-paced work environment Resilient mindset in the face of adversity Ability to work effectively in a team environment
Posted 1 month ago
8.0 - 12.0 years
15 - 22 Lacs
Hyderabad
Work from Office
• Bachelors degree in Engineering, Science, or Technical Discipline • Strong communication skills, both oral and written • Previous experience working with global team (Aerospace, Defence, Med device, automobile preferably) • PPAP and IQ, OQ & PQ
Posted 1 month ago
3.0 - 5.0 years
4 - 5 Lacs
Hyderabad, Madhapur, Telangana
Work from Office
QUALITY ASSURANCE & VALIDATION Responsible for development, implementation, and effectiveness of quality strategies, programs and functions for all products and technical solutions to meet all corporate and regulatory objectives with respect to quality initiatives. Summary: Plans, coordinates and directs activities concerned with DDi QMS, Quality manual, compliance related activities (ICH, 21 CFR, GPDR etc), SOP management, and regulatory compliance of processes and products. Plans and coordinates the quality management program designed to ensure quality development of products consistent with established standards. Accountabilities Interfaces with customers and vendors representing company as Quality champion. Formulates and maintains quality assurance objectives complementary to corporate policies and goals. Designs and implements quality assurance training programs to key personnel in conjunction with managers. Prepares and maintains control plans and revises/audits processes, responds to customers quality concerns. Manage client and regulatory authority audits Maintains companywide Quality Management System and ISO 9001, 27001 and ISO 14155 compliance. Oversee and own SOPs for entire organization Author or Review validation documentation (plans, protocols, test suites, reports, etc.). Contributes to project discoveries, project kickoffs, review proposals and statements of work to ensure CSV standards are represented. Coordinates client specific validation activities with practice leads. Enforce QA requirements for IT quality systems with potential GxP impact. Support GxP decisions/strategies during validation projects. Document applicable deviations and documentation anomalies for computer systems undergoing validation. Provides leadership throughout the lifecycle of a project, guiding the understanding of the validation process that the project team has through design, development, and implementation to ensure project requirements are met. Review requirements, traceability matrices, test suites and test executions. Travel involved. Other duties as assigned. KRA spread: QMS and corporate Quality management: 60% Validation: 40% Location - Madhapur, Hyderabad, Telangana,
Posted 1 month ago
0.0 - 2.0 years
2 - 6 Lacs
Chennai
Work from Office
Company: Blubridge Technologies Pvt Ltd Role: Data Scientist - R&D Vacancies: 15 Year of Passing Out: 2025, 2024, 2023 Education: Bachelors or Masters degree in Computer Science, IT, AI, Electronics & Communication, Data Science, etc. Job Location: Mandaveli, Chennai Analyze and preprocess large-scale datasets to ensure data quality and reliability. Develop and implement statistical and machine learning models, including transformer-based algorithms. Conduct exploratory data analysis to derive meaningful insights for research projects. Systematically explore and optimize hyperparameters and scaling laws to enhance model accuracy and efficiency. Collaborate with cross-functional teams to develop and refine experimental workflows. Implement comprehensive data collection strategies, scraping publicly available multi-domain sources for diverse content. Perform advanced preprocessing and deduplication, ensuring data is cleaned, normalized, and consistent. Design and manage rigorous quality assurance pipelines to validate data quality, diversity, and representativeness. Employ innovative multilingual tokenization and document packing techniques for efficient and cohesive context learning. Document methodologies, results, and contribute to research publications. Stay updated on the latest research methodologies, tools, and techniques in data science and AI. Requirements: Strong foundation in mathematics and statistics, including calculus, linear algebra, probability, and statistical inference. Excellent analytical and logical reasoning skills. Bachelors/Masters/PhD in Data Science, Statistics, Computer Science, AI, Machine Learning, or related fields. Added Advantage: Proficiency in Python and familiarity with relevant data science libraries (NumPy, Pandas, SciPy, Matplotlib, Scikit-learn). Good understanding of machine learning concepts and techniques. Demonstrated ability to work effectively within a collaborative research environment. Experience or familiarity with deep learning frameworks such as PyTorch, TensorFlow, or Hugging Face. Knowledge of distributed computing and optimization for GPU-based environments. Prior research experience or publications in data science or related fields. What We Offer: A dynamic and innovative work environment in a cutting-edge AI research team. Opportunities for professional growth, mentorship, and learning. Competitive salary and benefits. Access to high-performance computing resources for data analysis and modeling. Access to the latest tools and technologies in AI.
Posted 1 month ago
Upload Resume
Drag or click to upload
Your data is secure with us, protected by advanced encryption.
Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.
We have sent an OTP to your contact. Please enter it below to verify.
Accenture
39581 Jobs | Dublin
Wipro
19070 Jobs | Bengaluru
Accenture in India
14409 Jobs | Dublin 2
EY
14248 Jobs | London
Uplers
10536 Jobs | Ahmedabad
Amazon
10262 Jobs | Seattle,WA
IBM
9120 Jobs | Armonk
Oracle
8925 Jobs | Redwood City
Capgemini
7500 Jobs | Paris,France
Virtusa
7132 Jobs | Southborough