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2.0 - 8.0 years
0 Lacs
maharashtra
On-site
You will be working as an Officer/Sr. Officer/Executive/Sr. Executive with 2-8 years of experience in injectable Manufacturing. Your role will involve following instructions and procedures outlined in the Entry-Exit SOP for Grade C and Grade B areas, as well as ensuring proper functioning and behavior in the aseptic area. You will be responsible for adhering to personnel hygiene practices within the factory premises, following Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) as per SOP guidelines, and monitoring temperature, relative humidity, and differential pressure. Additionally, you will be tasked with overseeing the handling of material movement in the production area, maintaining documentation as per GDP and cGMP standards, and ensuring day-to-day records are accurately maintained. You will also be responsible for providing training to new chemists, workers, and operators, conducting line clearance before operations, and planning manufacturing based on raw material availability. Your duties will include supervising the preparation and filtration of cleaning/disinfectant solutions, ensuring equipment readiness before batch manufacturing, and overseeing the operation and cleaning of various machinery and utilities. You will verify load cell handling, monitor non-viable particle count, record operation and cleaning details, and handle equipment like homogenizers, pH meters, and foggers. Furthermore, you will be involved in activities such as aseptic process stimulation, media fill cleaning, and sanitization, as well as general area cleaning and sanitization in grade C and D areas. You will also be responsible for data entry in the pharmacloud system, audit preparation and execution, periodic medical checkups, and reporting unsafe acts/conditions/incidents to supervisors. Overall, you will play a crucial role in ensuring the smooth functioning of manufacturing processes and maintaining high standards of cleanliness, documentation, and safety within the pharmaceutical production environment.,
Posted 2 weeks ago
3.0 - 7.0 years
0 Lacs
machilipatnam, andhra pradesh
On-site
The Assistant Manager PM Planner IS & Facility is responsible for developing, scheduling, and implementing preventive maintenance (PM) programs for industrial systems (IS) and facility equipment. This role ensures compliance with food safety regulations, minimizes equipment downtime, and optimizes maintenance efficiency. You will work closely with internal teams and external service providers to ensure the reliability and performance of critical systems. You will develop and implement preventive maintenance schedules to minimize downtime and ensure compliance with food safety regulations. It is crucial to ensure that all maintenance activities align with Good Manufacturing Practices (GMP), HACCP, and other food safety standards. Utilizing SAP or CMMS to track PM tasks, maintenance records, and work orders will be an essential part of your responsibilities. Monitoring and updating maintenance SOPs, job plans, and equipment history for audits and compliance will also be a key aspect of this role. You will oversee and manage contracts with external maintenance vendors for various systems such as lifts, dumbwaiters, boilers, fire protection systems, water treatment, and ammonia refrigeration. Ensuring that vendors comply with food safety, regulatory, and performance standards is vital. Additionally, scheduling and coordinating contracted maintenance work to minimize disruption to production and evaluating vendor performance will be part of your duties. Planning and executing preventive maintenance for the Wastewater Treatment Plant (WWTP) equipment, boiler, thermal oil heater, ammonia refrigeration system, fire protection system, air scrubbers, ventilation systems, lifts, dumbwaiters, and water systems will be among your key responsibilities. Compliance with environmental and food industry regulations for each system is essential. Developing, updating, and maintaining Standard Operating Procedures (SOPs) for PM activities and ensuring compliance with HACCP, GMP, ISO, and local regulatory standards will be crucial. Training maintenance teams on SOP adherence and best practices, maintaining accurate maintenance records, inspection reports, and compliance documentation for audits, and supporting internal and external audits related to maintenance, safety, and food hygiene are also part of this role. Maintaining an inventory of critical spare parts for equipment servicing and working with procurement teams to source food-grade spare parts and consumables will be required. Identifying opportunities for energy efficiency, cost reduction, and system reliability improvements, and working with engineers, technicians, and production teams to enhance performance and reduce downtime are also part of this position. Qualification/Experience: - Degree in Mechanical, Electrical, or Facilities Engineering or a related field. - Minimum 3-5 years of experience in preventive maintenance planning in a food manufacturing environment. - Management of service contracts and vendor performance. - Strong knowledge of HACCP, GMP, food safety standards, and environmental regulations. - Proficiency in SAP, CMMS software, Microsoft Office, and maintenance scheduling tools. - Excellent problem-solving, organizational, and communication skills Relocation Assistance Eligible: No Work Shift: [Not provided],
Posted 2 weeks ago
3.0 - 7.0 years
0 Lacs
karnataka
On-site
The work you do every day at Illumina has the potential to impact the lives of people you know, as well as humanity as a whole. Illumina is dedicated to expanding access to genomic technology to achieve health equity for billions of individuals worldwide. This commitment leads to groundbreaking discoveries that revolutionize human health by enabling early disease detection, diagnosis, and innovative treatment options for patients. Being a part of Illumina means contributing to a larger purpose. Regardless of your role, you have the chance to make a meaningful difference. Surrounded by exceptional individuals, visionary leaders, and groundbreaking projects, you will exceed your expectations and discover your full potential. We are currently looking for a PLM Analyst to join our skilled team in Bangalore. In this role, you will play a crucial part in managing the core operations related to the Product Lifecycle within a dynamic and fast-paced organization, focusing on both new product development and on-market commercial operations. Your responsibilities will include creating and submitting change control requests, serving as a key resource in the change management process from initiation to product end-of-life for Illumina products, and maintaining product and process configurations in PLM and SAP ERP. You will collaborate with cross-functional teams to create Change Requests and Change Orders, ensuring that configuration and document changes contain all necessary information and addressing any arising issues. Responsibilities: - Utilize problem-solving skills to analyze the scope of Change and the relevant business dataset (e.g., Items, Documents, Bill of Materials, Facilities, EH&S). - Package Change scope efficiently into Change Requests and Change Orders to enhance operational efficiencies. - Prioritize processing Changes while aligning with defined Service Levels and expected metrics (e.g., turnaround time and quality service level). - Conduct comprehensive data analysis based on the Change scope to achieve a higher accuracy level of impacted items, including Item and Document searches by key attributes and descriptions within PLM and related systems (e.g., SAP, Camstar, LIMS). - Verify the accuracy and completeness of Change packages by collaborating with other Change Originators when necessary, following established procedures, work instructions, or job aids. - Perform data quality reviews during Change workflows, assessing data integrity risks, ensuring data completeness and accuracy, and advancing PLM workflows through lifecycle stages. Experience Required: - 3-5 years of prior professional experience in the PLM space of a MedTech company with a solid understanding of Enterprise Change Management, Master Data Management, and Enterprise Document Control. - Familiarity with basic GMP, regulatory, and compliance requirements of a MedTech company, such as 21 CFR 820 (Quality System Regulation), 21 CFR Part 11 (Electronic Records and Electronic Signatures), and 21 CFR Part 809 (In-Vitro Diagnostic Products). - Previous experience in a Data Stewards role handling Item and Document Master Data within a controlled environment is preferred.,
Posted 2 weeks ago
15.0 - 19.0 years
0 Lacs
telangana
On-site
As the Project Manager within Piramal Pharma Solutions" Engineering & Projects department based in Digwal, Hyderabad, you will have the overarching responsibility of managing projects from start to finish. This includes tasks such as design, budgeting, vendor coordination, and ensuring timely completion within optimal costs. Your role will involve ensuring compliance with various regulatory standards such as GMP, ISO 14001, and OHSAS 18001. Additionally, you will lead the commissioning, validation, and operational readiness of facilities and equipment, while proactively managing safety and environmental risks by implementing robust SHE practices. Continual improvement will be a key focus, achieved through risk assessments, CAPA implementation, and providing comprehensive training to both internal teams and contractors. Reporting directly to the Site Head, you will oversee a team of 6-8 individuals. To excel in this role, you are expected to bring at least 15 years of experience in Manufacturing, GMP, Safety, and resolving technical customer queries. Strong communication skills are essential for effective collaboration with various stakeholders. Key competencies required for this position include QMS handling, understanding changing regulatory requirements, confidence in facing audits, team management, conducting quality investigations, possessing analytical knowledge, collaborating with cross-functional teams (CFTs), and serving as the Single Point of Contact (SPOC) for CDMO projects. Your main responsibilities will revolve around the identification, evaluation, and implementation of projects within set timelines and budgets. This will involve designing facilities, selecting vendors and contractors, inspecting equipment and materials, issuing specifications and drawings, evaluating project progress, preparing budgets and schedules, overseeing project commissioning, validating facilities, and ensuring compliance with ISO14001:2004 and OHSAS 18001:1999 requirements. You will also be responsible for identifying risks and hazards, developing objectives and targets under EMS & OHSMS, implementing operational controls, conducting root cause analysis for non-conformities, and driving continual improvement in OHS & EMS Management Systems. Additionally, identifying SHE training needs, ensuring SHE requirements with contracted services and providers, and maintaining a focus on safety and environmental practices will be crucial aspects of your role.,
Posted 2 weeks ago
3.0 - 5.0 years
5 - 7 Lacs
Hyderabad
Work from Office
Summary The Regulatory Coordinator (RC) works under close supervision to support for development including line extension and /maintenance projects through development, registration, and approval including post approval commitments. To maximize operational effectiveness, collaborate with RA GDD Development Units, RA GDD CMC, Regional Representatives (MoW, LACan, EU, China, Japan), Novartis Technical Operations (NTO), and Quality Assurance to align on planning, execution, communication, and completion of assigned projects. . About the Role Key Responsibilities Ensure procurement of various key regulatory components (e. g. ordering certificates, GMP, registration samples, COA s and other regulatory documents as per the needed) to achieve marketing authorization and life cycle maintenance in collaboration with following internal and external stakeholders: NTO, Reg CMC, Global labelling & RA Ops for renewals SCM, Tech Ops for Regulatory samples, HA such as USFDA, Swiss medic/EMA & Consular Services for certificates etc, External Service providers Support for planning and management of timely delivery of critical regulatory materials (registration samples) and various regulatory authorized documents (certificates) for product license renewals, manufacturing site transfers & new registration submissions word wide (as per health authority requirements). For new submissions - Represents Regulatory Affairs LCM BOE team in in NTO project team meetings, RA global and regional team meetings. Organize regulatory readiness with relevant line functions and with Country Organizations & Regions for timely delivery of submission and approvals Track progress of assigned projects, including timelines and dossier deliveries. Ensure quality and compliance with global regulatory requirements, countries requirements and adherence to regulatory internal policies and processes Support for maintaining country requirement lists and conducting need-based surveys & interaction with country organizations. Contribute to non-project related initiatives and excellence activities Support lessons learned sessions and trainings within and external to RA GDD leading to improve strategies and decisions on common regulatory approaches. Minimum Requirements: Degree in Science (e. g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent Minimum of 3-5 years of experience in R egulatory A ffairs, related areas of the pharmaceutical Industry Good interpersonal and communication skills Ability to plan and prioritize work Ability to work effectively in a matrix environment Fluency in English written and spoken Why Novartis: Commitment to Diversity and Inclusion: Accessibility and accommodation Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork. novartis. com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:
Posted 2 weeks ago
3.0 - 5.0 years
5 - 7 Lacs
Bengaluru
Work from Office
Location: Any LTIM offices(Hybrid) Years of experience : 3+ years Mandatory skills: Trafficker(CM360/DCM, TTD) 0-30 joiners only will be considered. Job Summary: We are seeking technically proficient Ad Operations Specialist with hands-on experience in DCM (Campaign Manager 360) and The Trade Desk (TTD) creative trafficking. This role focuses on the end-to-end trafficking and QA of creatives across digital campaigns. The ideal candidate should also have experience working with IAS for ad verification and a basic understanding of dynamic creative platforms, such as Clinch. Key Responsibilities: - Upload and traffic display, video, and rich media creatives in DCM (CM360) - Assign creatives within The Trade Desk (TTD) as per creative mapping documentation - Generate click trackers, impression pixels, and manage third-party ad tags - Perform thorough QA for all creatives, including URLs, tags, formats, and rendering across environments - Validate IAS tracking pixels for viewability, fraud, and brand safety, and troubleshoot as needed - Work with creative teams and campaign managers to ensure accurate asset handoff and implementation - Track and manage versioning, re-trafficking needs, and approval workflows - Support DCO execution and validation, especially when using platforms like Clinch Requirements: - 3 5 years of experience in digital ad operations with expertise in DCM and TTD trafficking - Strong understanding of ad formats (HTML5, display, VAST/VPAID video, rich media) - Hands-on experience with IAS for verification tag management - Detail-oriented with strong QA and troubleshooting skills - Familiarity with Clinch or other DCO platforms is a plus - Comfortable using Excel/Google Sheets for asset tracking and trafficking logs Preferred Qualifications: - GMP (Campaign Manager 360) or The Trade Desk Edge Academy certification - Experience with other verification tools (DV, MOAT) - Experience in fast-paced media agencies or ad tech environments
Posted 2 weeks ago
8.0 - 12.0 years
25 - 30 Lacs
Panipat, Yamunanagar, Faridabad
Work from Office
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that s the kind of work we want to be part of. Key Responsibilities: Responsible for providing engineering and technical support to production personnel to maximize quality and productivity of capsule manufacturing process. Determines and specifies optimum processing parameters for Hard Capsule Machines. Provide guidance, training, and technical information to production personnel. Troubleshoot chronic manufacturing problems. Initiates and evaluates process improvement projects. Responsible for performing process engineering work to develop improved process and techniques. Coordinate activities of HCM, I box, Borsor processes. Actively seek solution & drive improvement in collaboration with maintenance & engineering team to reduce waste losses. Provides back-up for supervision in HCM and Borsor areas. Ensure Machine process parameters set points and measuring points are matching all the time and escalate for correction if any Define / Design the machine process parameter to meet the final product specification and function should meet the standard as desired. Ensure the GMS (Gauge measurement system) in process quality checks meets the specification . Doing process change as per the size change over when needed on HCMs Work and define the golden parameter for the process equipment like HCM machine, I box, Borsor, etc. in a reparative color / size change over Driving throughput increase initiatives using lean transformations like autonomous maintenance, Hoshin kanri, leader standard work, Gemba walks, Root Cause analysis, Value stream mapping, SMED etc. Coordinate with global teams to standardize the capsule manufacturing parameters Development of SOP s and core implementation for smooth running. CAPA development and implementation against customer complaints and coordinating with plan complaint management system team. Drive projects through study protocols, change control and validations. Driving the continuous improvement & lean transformation projects across the manufacturing operations eventually resulting into culture change, productivity & cost improvement Responsible for Process, People transformation by integrated lean six sigma methodology which impacts the Plant thruputs increase for poor performance lines using autonomous & lean manufacturing like SMED Yield improvements projects implementation like Production Yield improvement, consumable usage reduction, wastage reduction. Accountable for delivery of objectives in line with business targets like- Productivity, Machine uptime, Cost, Rejection levels, Yield, OEE, Quality, People development etc. Key Requirements: B.Tech Mechanical(preferred) / Electrical / Production / Chemical Engineering with 8 to 12 years of relevant experience in Process Engineering in Pharma and Food Industry. Hands on experience on Mechanical or electrical trouble shooting, Food safety experience, should have knowledge good housekeeping Practice and GMP, Operational Excellence experience. This is individual contributor role. Able to work in rotational shift working hours.
Posted 2 weeks ago
7.0 - 10.0 years
4 - 6 Lacs
Jaipur
Work from Office
Roles and Responsibilities Unit QA-in-Charge A quality assurance-in-charge in the food safety arena is responsible for policy, strategy and testing methodology to meet regulatory authority compliance in regard to the company product . They also assist in setting food safety standards and ensure that production is maintained at such standards and monitoring effective implementation of Food Safety Management System (FSSC 22K/ HACCP) Is responsible with the HACCP team to liaison with Operational And Quality standard related to the product and process and report to Unit Manager. To ensure that all inspections and tests of Raw materials, in process and Finished Products are Complied with. Accept or reject raw materials after necessary quality evaluation or testing in outside approved laboratory as per company's approved HACCP Plans. Provide adequate guidance to all staffs Responsible for discharging duties as per the companies Approved Standard operating Procedures (SOPs) Monitor sanitation and hygiene standards as per the companys approved Standard Sanitation Operating procedures (SSOPs) and to advice concerned in concurrence with reporting head on measures to be taken for complying with the approved SSOP. Responsible for ensuring that the approved Corrective And Preventive Actions are taken or implemented in time. Initiate action to prevent the occurrence of any Non-conformances related to products or process. Control further processing and or delivery of non-conforming Product until the deficiency or non-conformity has been Corrected. Arrangement for FSSC/ HACCP internal audit. Report to Unit Manager/ QA head/ Dept. reporting head immediately if any critical deviation is noted affecting the safety of the product prior to taking any corrective action. Maintain the Hygiene standards in co-operating with facility department. Provide training to all the staff on hygiene and food safety. Conduct the microbiological laboratory analysis of raw materials & finished products as per company requirement/ sampling plan. Verify documents on timely basis daily/ weekly as per the requirement. Monitor pest control activities are carried effectively as per the contract agreement in accordance with pest control schedule, frequency and proper dosage of approved chemicals. Also make sure that approved, branded and inspire chemicals are used for the entire activity. Desired Candidate Profile M. Sc. Microbiology b. M. Sc. Food Science & Nutrition c. M. Sc. Food science & Quality Control d. M. Sc. Food Technology Of which M. Sc. Microbiology is the most suitable with food industry experience. Perks and Benefits Accommodation+food+medicaid provided. Interested send your resumes on hrdpn@cafs.in or on 885940701. Note:- Only profiles of mentioned desired candidates will be shortlisted Of which M. Sc. Microbiology is the most suitable with food industry experience.
Posted 2 weeks ago
3.0 - 7.0 years
0 Lacs
maharashtra
On-site
As a part of ACG Associated Capsules Pvt. Ltd., your primary responsibilities will involve strategic planning activities. You will be responsible for ensuring the preparation of Feed Tank (FT) according to production requirements in a shift. It is crucial to maintain Good Manufacturing Practices (GMP), gowning, and safety protocols. You will oversee the shift handover/takeover on the shop floor and be accountable for any issues from the previous shift. Your duties will include compliance with the daily dipping schedule for FT preparation, color changes, and ZMICs for specific batch requirements. It is essential to ensure shade compliance on Mac bath to prevent productivity loss due to color shade variation. You will review and ensure 100% compliance with documentation practices for daily records, including various verifications and monitoring tasks. Furthermore, you will be responsible for executing Mac Bath Calibration, recipe verification for new shades, viscosity verification, and optimizing gelatin and water consumption. Compliance with safety guidelines, Environmental Management Systems, c-GMP, and other applicable norms is paramount. Internally, you will prepare various reports, monitor Multiskilling initiatives, and provide effective training to operators. People development is a key aspect, and you will ensure proper manning, shift handling, and activities. Achieving first-time-right feed tank preparation and optimizing gel consumption are critical Key Result Areas. Your interactions will involve internal interfaces such as Gel room, Stores, Quality, Engineering, and external interfaces including Customers, Auditors, and Visitors. Proficiency in GDP, GMP, MS Excel, AVSU, and knowledge of additives, colors, and manufacturing processes are essential competencies for this role. Your personal attributes as a Persona-Partner, Persona-Integrator, and Persona-Builder will contribute to your success in this position. The demonstration of values such as Caring, Collaborative, and Progressive during discussions will be evaluated. In summary, the Solution Preparation role at ACG Associated Capsules Pvt. Ltd. encompasses various strategic planning activities, documentation compliance, safety adherence, people development, and efficient production processes to achieve organizational goals effectively.,
Posted 2 weeks ago
3.0 - 7.0 years
0 Lacs
neemrana, rajasthan
On-site
You will be responsible for planning, executing, and documenting analytical method validation activities for raw materials, in-process samples, finished products, and cleaning validation. This includes assessing accuracy, precision, specificity, linearity, robustness, LOD/LOQ, and other parameters. You will review and approve validation protocols and reports in accordance with ICH Q2(R1), USP, and other regulatory standards to ensure compliance. Your role involves ensuring that all analytical method validation (AMV) activities adhere to GMP, GLP, and cGMP guidelines. Collaboration with R&D, QA, and Production teams is essential for seamless tech transfer and validation support. You will troubleshoot analytical method issues, propose enhancements, and recommend revalidations as needed. Maintenance and calibration of analytical instruments such as HPLC, GC, UV-Vis, and FTIR will be part of your responsibilities. In preparation for regulatory inspections and internal audits, you will participate in these processes. Additionally, you will play a key role in training and guiding junior QC staff on method validation procedures and regulatory expectations. It is crucial to ensure the completeness, accuracy, and proper archiving of all documentation as per standard operating procedures (SOPs). This position is based in Giloth, Neemrana, Rajasthan, and requires prior experience in a similar role. The job is full-time and permanent, offering benefits such as commuter assistance and provided meals. The work schedule is during day shifts with a yearly bonus component. The role necessitates on-site presence for work. If you meet the experience requirements and are adept at analytical method validation within a regulated environment, we invite you to apply for this challenging opportunity.,
Posted 2 weeks ago
5.0 - 9.0 years
0 Lacs
unnao, uttar pradesh
On-site
As an Analytical Chemist at Linde, you will utilize your knowledge of Quality control and GMP under FDA guidelines to ensure targets are met and plant parameters are optimized for maximum output and efficiency. Your role will involve ensuring compliance with local regulations and obtaining necessary approvals/licenses, particularly from the FDA. You will also play a key role in selecting suitable suppliers, agreeing on technical scope/solutions, conducting stage gate inspections for quality assurance, and assessing technical competency to assign tasks accordingly while ensuring safety and quality standards are maintained. Additionally, you will be responsible for making purchases for materials, assets, and services, as well as coordinating maintenance and troubleshooting activities. Your contribution will be vital in implementing directives, alerts, and improvement initiatives, as well as developing and sharing Root Cause Analysis reports. To excel in this role, you should hold a degree in B Sc Chemistry/BE/Bachelor of Pharmacy or an equivalent qualification, coupled with a minimum of 5 years of experience in the relevant field. Your ability to ensure compliance with local regulations and obtain necessary approvals/licenses, especially from the FDA, will be crucial to your success in this position. Linde is a globally renowned industrial gases and engineering company with operations in over 100 countries. We are committed to making the world more productive by providing high-quality solutions, technologies, and services that empower our customers, drive success, and contribute to the sustainability and protection of our planet. The joint venture between Linde India Limited and Praxair India Private Limited, LSAS Services Private Limited, aims to provide Operations and Management services to both entities while upholding a legacy of sustainable development and technological innovation in the industrial gases industry. As part of the Linde family, you will have limitless opportunities to realize your potential, make a positive impact, and contribute to a better world. Join us at Linde and embrace the limitless possibilities that lie ahead! If you are inspired by our vision and eager to be part of our dynamic team, we invite you to submit your complete application, including a motivation letter, CV, and certificates, through our online job market. Linde South Asia Services Pvt. Ltd. upholds a strong commitment to responsible business practices, technological innovation, and sustainable development across all its operations worldwide. We value diversity and inclusivity, and the language used here is intended for simplicity and clarity for all individuals.,
Posted 2 weeks ago
10.0 - 19.0 years
8 - 18 Lacs
Mumbai, Thane, Navi Mumbai
Work from Office
Requirement Experience in API Regulatory Affairs Routine job skill: Good conceptual, analytical, problem solving, reasoning and organizational skills. Should be change agile and have ability to work in highly matrixed environment. Attention to detail and accuracy required. Must be able to prioritize with independently/minimal guidance. Ability to handle multiple projects with good prioritization skills. Willingness to complete the work as per the committed timeline. Technical Skills: Sound understanding of drug development regulatory processes and requirements for defined market(s) and able to interpret and apply to projects. Ability to identify inconsistencies and deficiencies in technical data and escalates for resolution. Thorough knowledge and experience of drug development practice, rules, regulations, and guidelines. Demonstrates knowledge of key processes, procedures and tools. Regulatory Skills: Strong knowledge on the Regulatory requirements during both development and life-cycle management phases for US, Europe and other major markets and has expertise to oversee preparation and submission of complex regulatory submissions. Knowledge on current regulations and filings requirements for post approval. Competency in understanding and interpreting regulatory requirements and emerging regulatory landscape. Adequate level of knowledge on general standards SOP, processes and policies of Pharma industry. Leadership Skills: Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format. Ability to comprehend and summarize complex technical data. Ability to utilize flexible approaches to negotiate skillfully in tough situations with both internal and external groups. Gains trust quickly with cross functional team to the negotiations.
Posted 2 weeks ago
5.0 - 8.0 years
12 - 17 Lacs
Bengaluru
Work from Office
Production planning and Customer schedule adherence Manpower and Material planning as per Production/Delivery plan Training and development of Shopfloor associates and Lead team members Material stock accounting for Shopfloor Systematic Analysis of internal rejection & Customer complaints using Q-tools First Pass Yield improvement Analysis of rejection & problem solving Productivity and OEE improvement projects What we will offer you in the future Innovation and scope for growth International exposure Excellent working atmosphere What you bring with you for a future with us 5 to 8 years of experience as FLM Education Qualification: B.E. in Mechanical Engineering Automotive Industry experience Shift managing Knowledge on IATF system requirement Managing operators Knowledge on SAP production module
Posted 2 weeks ago
0.0 - 2.0 years
2 - 4 Lacs
Tirupati
Work from Office
Associate Trainee Job Description As a person, you re a learner a natural leader someone who is always taking initiative to make things better and bring others along with you. You live your life in alignment with the highest values of integrity and quality, always ensuring your responsibilities become a long-term success story. In this role, you ll help us deliver better care for billions of people around the world. It starts with YOU. About You You perform at the highest level possible, and you appreciate a performance culture fueled by authentic caring. You want to be part of a company actively dedicated to sustainability, inclusion, wellbeing, and career development. You love what you do, especially when the work you do makes a difference. At Kimberly-Clark, we re constantly exploring new ideas on how, when, and where we can best achieve results. In one of our Manufacturing roles, you ll focus on winning with consumers and the market, while putting safety, mutual respect, and human dignity at the center. To succeed in this role, you will need the following qualifications: Education: DiplomaFresher in Mechanical and Electrical Overall Safety Expectations: Follow all KC Safety rules and Guidelines. Take care of Own safety as well as others safety. Perform periodic safety observations to identify hazards and support in closing those. Report near miss, abnormal condition, and Unsafe act on timely manner. Follow risk assessment, work SOPs, LOTO Management, work permit, Emergency response plan, safety target, PCS, and other safety compliance. Overall Quality Expectations: Follow personal hygiene, workplace hygiene, all GMP (Good manufacturing practices) as per KC guidelines and QMS (Quality management system). Focus on actions keeping customer and consumer expectations at the center. Individual actions should contribute to delivering high quality product to the market. Quality Focused mindset to maintain the highest level of product quality from customer point. Team of Production Associates for Machine: Raw material & Packing Material preparation, loading, Splicing, and unloading activity at shift level. Material threading and routing with defined route and recheck product after material splicing. Machine troubleshooting for Breakdown, Quality Defects and Short stops. Conduct problem solving RCA periodically. Follow Machine and work area cleaning and maintain 5S of shop floor. Document all material traceability report, Production logbook and Packing Logbook and others. Perform real time variable and attribute checks for various product and packaging quality parameters. Record the results of quality inspection in quality system/ Software & other quality documents. Follow non confirming product handling quality guidelines to ensure only good products are shipped out. Segregate, recheck the products put on hold for quality reasons. Set and run the machine on center line, good run settings (GRS) and maintain all critical machine settings/equipment s to deliver safe product to the market. Achieve volume delivery KPI, OEE, Waste, other Performance KPI, Quality & Safety KPI. Perform Cleaning, Lubrication, Inspection and Tightening on machine for maintaining machine condition Follow all machine visual health checkup, Temperature checks, Vibration checks, Greasing and Oiling checks, Abnormal behavior checks and make plan to close abnormalities for continuous good performance. Perform Preventive & Predictive Maintenance periodically to maintain machine in better condition. Perform proper cleaning on holt melt application for increasing life span of part and better operational performance. Follow systematic replacement of spare parts (based on life cycle and condition) for breakdown free operation of Machine. Carryout pack count change, Product size change, Tier Change applying QCO (Quick changeover) Lean principle. Follow Data entry on timely manner for M/C downtime, Stops, Waste, Production and machine performance tracking in Different software and MIS system. Focus on Lean Manufacturing for reduction material and product waste and improving product quality. Apply Kaizen Principle, continuous improvement thinking and deliver benchmark performance in Safety, Quality, Productivity, Cost, and compliance KPIs. Quality Assurance Associate: Follow all Personal Hygiene, Plant hygiene, and pest control for maintaining good GMP. Perform all Quality testing for product verification. Follow Customer complaint procedure, Quality Defects of product & RMPM. Follow Real time inspection, Grade change inspection, Variable and attribute testing, Packing and Artwork checking. Document all Quality testing results in Quality software and such other soft/ hard copy records. Conduct periodic quality audits for critical control points, Quality systems, 5S and different parts of QMS (Quality Management System) Follow Product clearance procedure and Product hold protocol on timely manner. Perform Equipment calibration activity for better accuracy of Equipment. Mechanical Engineering Associate: Follow Store Inventory System for spare tracking, Issue spare to authorize person with defined procedure, maintain Reorder level based on criticality index- Cost, lead time, frequency. Perform overhauling activity of units and modules to make them ready for next use. Perform Stock count activity for stock matching, shift end spare issue and stock accuracy, 5S activity, store audit for findings and improvement. Hotmelt part refurbishment, Cleaning, Testing and make them ready as a spare. Ink jet Coding machine maintenance and repair from breakdown and make them ready for operation. Support in maintenance on machine during PM and changeover activity. Utility Associate: Utility and Electrical operation. Operation and maintenance of Utility and Electrical Transformer, HT, LT room, DG set, Compressor, Chillers, AHU, WTP, STP. Reports filling and preventive schedule follow and ensuring the equipment high. Support in Panels maintenance, Installation of new projects in the Mill. Ensuring the uninterrupted mill operation Safety firefighting system, pump room, understanding of UPS, VFD, Motors, maintaining Building Management System (BMS) and Energy Management System (EMS), cooling towers operation and maintenance To Be Considered Click the Apply button and complete the online application process. A member of our recruiting team will review your application and follow up if you seem like a great fit for this role. In the meantime, please check out the careers website . Primary Location Sricity Mill Additional Locations Worker Type Employee Worker Sub-Type Regular Time Type Full time
Posted 2 weeks ago
7.0 - 12.0 years
9 - 14 Lacs
Bengaluru
Work from Office
About Toll Group At Toll, we do more than just logistics - we move the businesses that move the world. Our 16,000 team members can help solve any logistics, transport, or supply chain challenge big or small. We have been supporting our customers for more than 130 years. Today, we support more than 20,000 customers worldwide with 500 sites in 27 markets, and a forwarding network spanning 150 countries. We are proudly part of Japan Post www.tollgroup.com About Toll Asia Logistics Grow your career with Global Logistics, as we expand our operations across Asia. With a passion for progress, we re playing our part in a vital industry that keeps global communities doing, moving and growing. We re driven to be the best logistics partner for our customers. Our positivity and teamwork is recognised when we go above and beyond to share our knowledge, improve how we work and solve complex problems. While every day brings a different challenge, we adapt with the autonomy to make fast decisions. Experience a caring and collaborative culture, where there is respect for our diverse backgrounds, skills, ideas and flexibility for our wellbeing. Progress your career through training, on-the-job learning and mobility, all in a safe, stable and secure working environment. The opportunity Lead, direct, and manage logistics and embellishment operations to ensure the team delivers high-quality service and customer satisfaction. The role also focuses on achieving profitable and cost-efficient operations while ensuring compliance with company policies, ISO standards, GDP regulations, and other guidelines. Prepare, monitor, and implement SOPs and related formats Ensure site functions like pest control, preventive maintenance, and cleaning are effectively managed by site management, with issues escalated when necessary Ensure the organization complies with client standards, quality agreements, and regulatory norms Support the development and maintenance of quality systems with clients and operations to ensure all warehouse activities follow approved SOPs and regulatory guidelines (GMP, GDP, etc.) Conduct and oversee monthly management reviews for each client Track performance statistics and maintain accurate records of operational documents What you ll need to succeed Experience in a similar role handling large-scale logistics operations (FMCG) A minimum of 10 years of WAREHOUSING experience FMCG warehousing is mandatory What moves you? Are you excited about this role but are concerned you don t meet all the requirements? If you have similar skills and are willing to learn then we encourage you to apply anyway. We know that some people hesitate to apply for jobs unless they meet every single qualification. At Toll, we value a diverse, inclusive and authentic workplace, so if you re interested in this role but your past experience doesn t align perfectly then please talk to us you may be just the right candidate for this or other roles we have coming up. At Toll everyone is welcome including those of all ages, ethnicities, genders and abilities. To find out more about us visit www.careers.tollgroup.com You must be entitled to work in India and be prepared to undertake pre-employment checks including a criminal history check and medical.
Posted 2 weeks ago
1.0 - 2.0 years
3 - 4 Lacs
Gurugram, Manesar
Work from Office
Job Description Implements, manages and maintains an Engineering Change Notice System which includes master data management, document management and facilitation of the change control processes over the product lifecycle in Agilents ERP systems. Documents changes related to product improvements, repairs, and new product development for all parts, products and tools. Coordinates the interaction between R&D Engineering, Manufacturing, Procurement, Planning, and Finance to ensure appropriate changes are documented. May provide documentation such as good manufacturing practices (GMP), good laboratory practices (GLP), and good clinical practices (GCP) procedure manuals and change authorization in accordance with company policies and government regulations. Qualifications Bachelors or Masters Degree or equivalent. Post-graduate, certification, and/or license may be required. Typically, at least 1-2+ years relevant experience. Additional Details This job has a full time weekly schedule. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https: / / careers.agilent.com / locations Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws. Travel Required: 10% of the Time Shift: Day Duration: No End Date Job Function: Manufacturing
Posted 2 weeks ago
5.0 - 10.0 years
7 - 12 Lacs
Gandhidham
Work from Office
Senior Officer - External Manufacturing Job Details | Tata Consumer Products Limited Search by Keyword Search by Location Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Senior Officer - External Manufacturing Tata Consumer Products Limited Senior Officer - External Manufacturing Tata Consumer Products Ltd. About the Job: Senior Officer External Manufacturing Product Supply Organization Senior Manager External Manufacturing At Tata Consumer Products Ltd, we stand #Forbetter Planet, Sourcing, Nutrition, Communities. And #ForBetter Opportunities . Here s an exciting one! How does this Job align to our Strategy? At the core of Tata Consumer Products business approach lie six strategic pillars that serve as the foundation for its growth and success: Strengthening & Accelerating our Core Business, Digital and Innovation, a Future-Ready Organization, New Opportunities and Sustainability. This job opportunity closely aligns with one of these key strategic pillars, which is driving Strengthening & Accelerating our Core Business . The role involves managing the operations of multiple 3p foods units for the respective region. T he job aims to bring tangible business value by strengthening & accelerating our core business. The role would require you to travel. Where do you come in as? SVP & Head Manufacturing & Procurement Executive Director & COO Vice President External Manufacturing & Organic India Operations Associate Director External Manufacturing Senior Manager External Manufacturing Senior Officer External Manufacturing This job is at N-6 level (N corresponds to CEO s level) Complexity of the role (Optional): Type of Role : Primary Stakeholders (Optional) What are the Key Deliverables in this role? To explore opportunities for cost optimization mechanisms- Negotiation & management of operational cost with 3p co-packers at multiple 3p food units in the respective category (Pulses, Poha, Value added Salt) and the designated region. To drive cost efficiency for the 3p food units in the region through focus on reducing fixed cost per MT & variable cost per MT To improvise OTIF and Fill rates across various channels To drive audits closures (Quality & Stock audits) for all the 3p units in the region within agreed timelines To ensure that 3P/2P units complies & adheres with the terms and conditions of the Food Safety & Quality standards with no deviation & minimum number of customer complaints per million. To drive team engagement fostering culture of collaboration, execution mindset and growth mindset behaviour Monitor and review operations at 3P/2P sites, drive production plan adherence while maintaining high level of food safety management system within organizational guidelines to ensure smooth contract manufacturing operations as per the budgeted sales plan. To ensure the capacity availability as per agreed volumes and timelines for all products including NPDs in the respective region To drive Health & Safety standards and all statutory compliances for the units in the region Identify & develop new 2P/3P vendors and bring them on-board following the process as per business requirements Foster Innovation through process improvement projects & driving improvement in GMP audit scores in salt units Facilitate the innovation pipeline & timely launch & smooth execution of NPD products in Foods category while coordinating with the internal (Sales, R&D, Marketing, Procurement, S&OP) and external stakeholders. Development and Implementation of 3P processes, ensuring policies and Negotiations as per contracts. Engineering degree (M.B.A Added advantage) Prior 5+ years in FMCG Industry especially Foods & Beverages 3+ years experience in management of 3p manufacturing units at multiple sites capabilities; negotiation skills, network with the regional 3p/2p manufacturers What are the Desirable success factors for the Role? Understanding & Experience of manufacturing operations. Analytical and problem-solving abilities , with a focus on delivering actionable insights and innovative solutions TCPL Growth Mindset and Behaviors About Us: At Tata Consumer, we stand For Better. Tata Consumer Products is a focused consumer products company uniting the principal food and beverage interests of the Tata Group under one umbrella. Our brands embody our purpose of For Better through the value they deliver to consumers with a focus on innovation, health and wellness, convenience and premiumisation. The Company s portfolio of products includes tea, coffee, water, RTD, salt, pulses, spices, ready-to-cook and ready-to-eat offerings, breakfast cereals, snacks and mini meals. Our key brands include Tata Tea, Tetley, Eight O Clock Coffee, Tata Coffee Grand, Himalayan Natural Mineral Water, Tata Copper+ and Tata Gluco+, Tata Salt, Tata Sampann and Tata Soulfull. In India, Tata Consumer Products has a reach of over 200 million households, giving it an unparalleled ability to leverage the Tata brand in consumer products.
Posted 2 weeks ago
10.0 - 16.0 years
35 - 40 Lacs
Bengaluru
Work from Office
Job responsibilities include some of the following: Product & Process Knowledge Management: Data gathering ( Product Quality Review, Change Requests, Methods of Production, Genealogical tree and quality reporting, PHF Parking lot (document with the pending point of the previous version of PHF. Manage PHF governance & operational follow up meetings: (kick off, consolidation, follow up ) Write/update the PHF s with information gathered and manage the approval process with identified stakeholders. PHF Publishing in Veeva, Manage AAR with stakeholders, PHF continuous improvement Collaboration and Communication: Work collaboratively with various departments, including MSAT discipline experts, QA, GCC associates. Documentation and right first time: Ensure the consistent quality of the PHF s. Innovation: Identify opportunities for innovation based on scientific advancements and emerging trends ( IA, digitalization, Training and Development: train staff and stakeholders on best knowledge management practices in close collaboration with MSAT information and knowledge management experts. Checking that the PHF knowledge management strategy laid out by the Global MSAT Compliance and Knowledge Management Process Excellence lead is being respected. Basic Qualifications: Bachelor s Degree ideally with a Ph.D. in a relevant scientific discipline (e.g., biology, chemistry, pharmacy ) Experience: at least 10-16 years of experience in pharmaceutical or biopharmaceutical MSAT or a related field. A working experience of at least 3+ years as a scientific writer or in a similar role is key asset. S takeholder engagement experience in an international and matrixial environment. Advanced scientific writing skills and capabilities . Strong communication, team management skills and interpersonal skills. Strong attention to detail and ability to produce high-quality, accurate documents. Uphold the highest standards of scientific integrity and ethics. Analytical and problem-solving skills. Strong knowledge and understanding of Pharmaceutical or Biopharmaceutical environment. Knowledge and understanding of Good Manufacturing Practice (GMP). Knowledge of regulatory requirements and industry standards. Advanced Written and oral fluency in English. Office tools: Classical (word, excel, PowerPoint) and specific (Office Timeline Pro, pdf creator), Documentum & SAP GSK Access (PHF, PQR, general R&D doc, Techshare, ) Veeva GSK Access . Preferred Qualifications: MSAT, or Manufacturing Science and Technology, is a critical function within a pharmaceutical and biopharmaceutical manufacturing organization in general. The GSK MSAT team is responsible for ensuring that products are produced safely, efficiently, and to the highest quality standards. Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making using evidence and applying judgement to balance pace, rigour and risk Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose to unite science, technology and talent to get ahead of disease together so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Important notice to Employment businesses/ Agencies
Posted 2 weeks ago
10.0 - 16.0 years
35 - 40 Lacs
Bengaluru
Work from Office
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following : The position comprises an array of activities linked to that lead to the successful execution of replacing the animal derived reagent LAL with rFC in the endotoxin test methodology that is embedded in GSK strategy. This includes but is not limited to working with internal and external partners to ensure timely transition to the recombinant systems at all internal GSK sites and at CRO /CMO. The job owner has a role in Analytical Science supporting Large Molecules, Small Molecules and Vaccines divisions including related CMOs. The job owner has a role to collect, analyse, plan and align studies for Endotoxin testing. This includes Sample organization incl. shipment and potential linked change control for sample management where required. Authoring of respective study plans and reports according to GSK requirements. The job owner will work with internal and or external laboratories for outsourced endotoxin analyses i.e. set up adequate study protocols aligned with GSK requirements, coordinate the samples collection and shipment to the laboratory, received the study test results report and write the GSK final study reports applying GMP and GDP practices including respect of Data Integrity rules. This includes CRO contract negotiation to execute the laboratory work incl. Budget management. The job owner ensures the correct program execution at all impacted internal and external sites by setting and tracking SMART and ambitious objectives in alignment with GSK priorities. This includes identification and mitigation of risks throughout the project lifecycle to ensure smooth implementation. This includes management of the project budget in compliance and according to GSK standard. Further the conduction of required program and project steering and linked documentation, minutes and reports are produced in a timely manner and are shared with major stakeholders and archived in line with the Company requirements. The job owner builds strategic product roadmaps in MSAT and R&D and ensures that lab work is prioritized accordingly regarding method development, validation to support timely submission planning. This includes oversight laboratory work and interim progress evaluation to identify and mitigate risks throughout the project lifecycle to ensure smooth implementation. The job owner provides expertise and supporting the GSK network sites and other Global MSAT functions teams engaged in the execution of recombinant endotoxin testing. This expertise is transferred through support, training and guidance. Basic Qualifications: Experience: at least 10-16 years of experience in pharmaceutical or biopharmaceutical MSAT or a related field. A working experience of at least 10+ years in the field of microbiology and endotoxin and pyrogen testing is required Education: Scientific and Analytical background with a degree, preferably advanced, in Microbiology, Biology or similar field of study. Trained on systems used in GSK e.g. an advantage Excel, other IT skills a MUST, (SAP, GLIM), change control, electronic laboratory notebook a plus Knowledge of GMP regulated environment and linked analytical methods. Knowledge of Biopharmaceuticals production and cGMP regulations, guidelines, Pharmacopeia is an advantage Pro active and Autonomous worker with a strong focus on execution Ability to prioritize and problem solving mind set Hands on mentality, pragmatic thinking Good team player with strong organization and communication skills for managing a vast majority of stakeholders from senior management to operational level. Intercultural interaction and exchange with people. Problem solving and Prioritization skills Execution & coordination skills in validation Proficient in both written and spoken English. French is an advantage Preferred Qualifications: MSAT, or Manufacturing Science and Technology, is a critical function within a pharmaceutical and biopharmaceutical manufacturing organization in general. The GSK MSAT team is responsible for ensuring that products are produced safely, efficiently, and to the highest quality standards Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making using evidence and applying judgement to balance pace, rigour and risk Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose to unite science, technology and talent to get ahead of disease together so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Important notice to Employment businesses/ Agencies
Posted 2 weeks ago
16.0 - 25.0 years
20 - 25 Lacs
Ahmednagar
Work from Office
Title: Senior Manager QC Business Unit: QC Job Grade G9B / Senior Manager Location : Ahmednagar Key Responsibilities At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you ll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other s journeys. JOB SUMMARY: To ensure on handling of documents like analytical test procedures, specifications, standard operating procedures from initiation till implementation. To ensure quality control GLP related activities are performed as per SOP for calibration, qualification of instrument and equipment. To ensure sampling activities are performed as per SOP and sample integrity are maintained till analysis completion. To ensure working/reference standards are made available for analysis and timely qualification of standards within due date. To involve in investigations and to collaborate with cross function team for root cause determination and implementation of effective CAPA. To ensure safety and use of required personal protective equipment s during day-to-day activities. Responsible for carrying out any other responsibilities assigned from time to time orally or in writing by HOD. To maintain and enhance quality index of the site unit data elements pertaining to QC function. Identify the training need and organize for the training to concerned group in QC to avoid event and unconfirmed OOS due to errors during analysis. ESSENTIAL JOB FUNCTIONS: To ensure stability samples are charged and analysis completed within the due date and stability chambers are monitored and maintained at respective conditions. To ensure effective analytical methodology are placed for testing. To ensure analytical method validation and analytical method transfer activities are completed and validated methods are adopted for testing. To ensure sampling activities of RM/Intermediates/Finished as per approved standard operating procedures. To ensure stability study sampling, stability study chamber monitoring and timely withdrawal and completion of analysis. To review the analytical method validation, method transfer, regulatory submission related documents, working reference standard procurements. To co-ordinate self-inspection (internal audit) and its compliances. To approve the lab event/out of specification/our of trend/our of calibration/CAPA/change control/deviation. Ensure trend of quality control errors and effective CAPA implementation. To monitor the compliance with the requirement of GMP. To participate in the management reviews of process performances, product quality and of the quality management systems and advocating continual improvement. To ensure a timely and effective communication and escalation process exists to raise quality issues to appropriate levels of management. To conduct training program and ensure it effectiveness. To ensure quality control GLP related activities are performed as per SOP for calibration, qualification of instrument and equipment. To follow safety & use of required personal protective equipment during day to day activities. To ensure maintenance of housekeeping at shop floor and reporting day to day activities to QC head and in absence delegate change to second line manager. To participate in laboratory internal audits, customer audits, health authority inspection. Awareness of IMS systems (ISO14001:2015 and ISO45001:2018) Travel Estimate Low Job Requirements Educational Qualification M. Sc Chemistry Experience 15+ years Your Success Matters to Us At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let s create a brighter future together!
Posted 2 weeks ago
0.0 - 5.0 years
14 - 16 Lacs
Bengaluru
Work from Office
Check Point Software Technologies Ltd is looking for Harmony Sales Specialist to join our dynamic team and embark on a rewarding career journey Diagnosing and treating illnesses, medical conditions, and injuries. Ordering, performing, and interpreting diagnostic tests. Collecting, recording, and maintaining patients' information and histories. Prescribing and administering treatments, therapies, medications, vaccinations, and other specialized medical care. Explaining procedures and discussing test results or prescribed treatments with patients and family members. Monitoring patients' conditions and progress. Directing, coordinating, consulting with, and referring patients to nurses, students, assistants, specialists, therapists, and other medical staff. Advising patients, parents, and guardians on diets, activities, hygiene, and disease prevention. Conducting research and remaining up to date on current trends, discoveries, and developments in the field
Posted 2 weeks ago
3.0 - 6.0 years
12 - 16 Lacs
Warangal, Hyderabad, Nizamabad
Work from Office
Summary Design, plan, perform, interpret and report results of scientific experiments for the method development of drug substances (DS) and drug products (DP) within global ARD. Lead and manage all project/local network activities, support/coach team members, participate in sub-teams and contribute to overall TRD strategies and goals. About the Role Major activities Develop and qualify various analytical methods (e.g., fast LC, titration, dissolution). Provide analytical and technical support to PHAD/project team at various stages of product development (e.g., CSF, FMI and LCM). Design and author analytical documents (e.g., Analytical methods, Stability protocols/reports, Excipient compatibility (EC) protocol/reports; APS protocols/reports, etc.) Support Analytical project leader for setting analytical development strategy. Support in data interpretation, results compilations and sharing the information with critical observations and proposals to project team. Responsible for project related sample handling (e.g., sampling plans, issuance, storage, distribution, reconciliation/destruction of the samples) . Support planning for assigned project activities. Accountable to meet KQI (Key quality indicators) and KPI (Key performance indicators) for all assigned project activities. Provide requests for lab activities to the associates and stakeholders. Manage project activities including logistics at third parties and external testing laboratories. Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s). Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISEC Novartis Guidelines. Subway: Author (EC/APS protocol and reports), review of test methods and compatibility study plan. ESOPS: Read SOP access and Review of SOPs. Ideal background Education and experience : M.Sc. /M. Pharm/ Ph.D. with relevant experience. Languages: Good knowledge of English and site language (oral and written). Professional requirement: Recognized expertise in analytical methodology and broad scientific as well as technical and strategic background. Demonstrated successful experience with working in interdisciplinary and cross-cultural teams. Demonstrated leadership and advanced coaching and mentoring skills. Thorough knowledge of relevant SOP, GMP and Novartis regulations and policies if applicable. Excellent communication/presentation skills and scientific. Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:
Posted 2 weeks ago
6.0 - 8.0 years
7 - 8 Lacs
Ahmedabad
Work from Office
HOCCO -ICE Cream is Hiring !! Position - Mechanical Engineer Job Location- Bavla- Ahmedabad We are seeking a skilled and experienced Mechanical Engineer to join our team for a Ice Cream plant . The ideal candidate will be responsible for planning, installation, testing, and commissioning of all mechanical systems and utilities, ensuring seamless operations aligned with food processing standards. Key Responsibilities : Project Planning & Execution : Assist in planning and executing mechanical aspects of the new ice cream plant setup. Coordinate with consultants, vendors, and contractors for timely delivery and installation. Design & Equipment Selection : Evaluate and select appropriate equipment (freezers, homogenizers, pasteurizers, conveyors, etc.). Ensure compliance with industry standards and plant layout efficiency. Installation & Commissioning : Supervise mechanical installation and commissioning activities. Conduct performance testing and validations of all installed systems. Maintenance Planning : Develop preventive maintenance schedules for all mechanical systems post-commissioning. Ensure long-term equipment reliability and minimal downtime. Documentation & Compliance : Prepare technical documentation, installation reports, and as-built drawings. Ensure all systems meet FSSAI, ISO, and safety compliance standards. Cross-Functional Coordination : Collaborate with Electrical, Utility, Production, and QA teams during setup and commissioning. Coordinate with OEMs and service providers for timely support. Key Skills and Competencies : Strong knowledge of mechanical systems in food or dairy processing plants Familiarity with refrigeration systems , pneumatics , and compressed air systems Experience in handling installation and commissioning of process equipment Excellent project management, vendor coordination, and troubleshooting skills Understanding of GMP , HACCP , and other regulatory standards Qualifications : Bachelors degree in Mechanical Engineering 6 To 8 years of relevant experience in food/dairy/ice cream plant projects Prior involvement in greenfield or brownfield projects is preferred
Posted 2 weeks ago
8.0 - 12.0 years
3 - 5 Lacs
Hyderabad
Work from Office
Plan and implement preventive, predictive, and corrective maintenance schedules for all production and utility equipment (HVAC, AHU, WTP, Compressors, Boilers) Maintain proper documentation including validation, maintenance logs as per SOPs and audit
Posted 2 weeks ago
2.0 - 6.0 years
6 - 10 Lacs
Gurugram
Work from Office
Eurofins Consumer Product Testing India provides high standard quality assurance and control services, such as testing, certification, inspection, audits, technical and regulatory services, to manufacturers, brand owners, distributors and trading companies, buying associations, consumer associations, and retailers worldwide. We are dealing with various consumer product testing like: "¢ Fabric and Textiles "¢ Cosmetics "¢ Food contact materials "¢ Toys "¢ Detergents "¢ Apparel "¢ Rubber "¢ Leather "¢ Plastics "¢ Accessories "¢ Footwear "¢ Home Textiles With EUR 4.5 billion in annual revenues and 50,000 employees across over 800+ laboratories across 50 countries, Eurons Scientic is a leading international group of laboratories providing a unique range of analytical testing services to the pharmaceutical, food, environmental and consumer products industries and to governments. Roles and Responsibilities Sample control and file keeping to client and follow up to match the TAT Good connect and coordination with external Clients, Sales team & lab team. To ensure to attend and clear the entire query from client and vendor in an efficient manner New on Boarding Vendor Management(NOB) Hold Reduction. Maintaining all the Quality records generated during the process. Ensure confidentiality of information obtained during the course of employment. Closely working with Sales & Operations team Qualifications Graduate or MBA From Textile industry Additional Information Compensation will be between 3 - 8 LPA based on current.
Posted 2 weeks ago
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