At Smith+Nephew , we design and manufacture technology that takes the limits off living! The IT Business Analyst for Regulatory Affairs will collaborate with business leaders and product owners to define, justify, and deliver IT solutions that meet business objectives, create competitive advantage, and leverage internal and external IT resources. Responsibilities include contributing to strategy, gathering requirements, advising on industry trends, building capability roadmaps for short- and long-term needs, and analyzing processes for improvement and cost-benefit. What will you be doing? Provides Business Analysis and Requirements management in support of Regulatory Affairs group Elicit, define, analyze, and document testable business requirements, collaborating closely with customers, end users, and the IT team. Leverage good communication and analytical skills, business relationships, and business process expertise to understand, document, assess, and drive business change needs to accelerate process improvement and business growth. Drives re-use of existing solution capability or introduction of new technology to achieve program or project objectives Works independently and simultaneously on multiple projects with various domain experts to understand current business process landscape, enterprise alignment, and growth. Business Analysis ownership for [functional processes], Identify and evaluate potential solutions, favouring existing invest application estate. Prepares cases which define potential benefits, options for achieving these benefits through development of new or changed processes, and associated business risks. Measurably improve business process capability and performance indicators for delivered projects Attain a high re-use of technology while driving process standardization for owned processes Drives effective requirements' definition that creates objective, testable requirements that results in a business solution which meets or exceeds the defined objectives. Create functional requirements in Use Cases. Coordinate requirements walk-through and signoffs, verifying with collaborators that Use Cases and process models accurately portray specific business needs. Recommends options that best fit the business needs, value proposition and strategic roadmap. Identifies, analyses, and fixes the root cause of business and technical issues. What will you need to be successful? Education: Bachelors or masters degree in computer science, information systems, business administration, or other related field, or equivalent work experience. Experience : Minimum 5-7 years of relevant technical or business work experience . With at least 3 years of experience in information technology & regulatory affairs . Certification in business analysis is preferred. Proven Experience with Rimsys and PTC Windchill (PLM systems) Solid experience working within GxP-regulated environments , including validation of systems, Quality Systems, and compliance with regulatory standards Business process design and reengineering techniques and methods. Business analysis: takes responsibility for investigative work to determine business requirements and specify effective business processes through improvements in information systems, information management, practices, procedures, and organizational change. Selects and embraces suitable business analysis methods, tools, and techniques, selecting the appropriate approach from predictive (plan driven) or adaptive methods (iterative/agile). Collaborates with partners at all levels in the conduct of investigations for strategy studies, business requirements specifications, and feasibility studies. Designs and manages tests of new/updated processes. Manages selection/creation of relevant scenarios for testing and ensures that tests reflect realistic operational business conditions. Ensure tests and results are documented, reported to partners, and are available for specification of user instructions. Highlights issues and risks identified during testing to business customers. Defines and manages prioritizing, requirements definition, and prioritization activities for initiatives of medium size and complexity. Facilitates input from customers, provides constructive challenge, and enables effective prioritization of requirements. You Unlimited. We believe in crafting the greatest good for society. Our strongest investments are in our people and the patients we serve. Inclusion, Diversity and Equity: Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/). Other reasons why you will love it here! Your Future: Major medical coverage + policy exclusions and insurance non-medical limit. Educational Assistance. Work/Life Balance: Flexible Personal/Vacation Time Off, Privilege Leave, Floater Leave. Your Wellbeing: Parents/Parents in Laws Insurance (Employer Contribution of 8,000/- annually), Employee Assistance Program, Parental Leave. Flexibility : Hybrid Work Model (For most professional roles) Training: Hands-On, Team-Customized, Mentorship Extra Perks: Free Cab Transport Facility for all employees; One-Time Meal provided to all employees as per shift. Night shift allowances.

Role & responsibilities Excels in managing the quality inspection & release programs for company's Pharma products and leading validation, qualification, QA, analysis & sampling of Raw Materials (API & Formulation) and Packaging Material. Expertise in driving QMS/QC Activities - OOS, Deviation, Change Control, Risk Assessment, Investigations, RCA, CAPA, Audits, Equipment Calibration & Validation on the shop floor for ensuring adherence to GMP and Regulatory Compliance.

Summary Provide regulatory CMC operational, submission and compliance support to department in accordance to defined requirements to guarantee timely preparation of high-quality CMC regulatory submissions and associated compliance information throughout the life cycle. About the Role Major accountabilities: Perform compliance and operational activities including QC check, DA checks and IND annual report writing. CMC contact for some countries and compliance/ regulatory database entry and reports Create CMC submission documentation such as folders structure, metadata forms, RA request forms and act as data stewards in the applicable Regulatory Information Management System Ensure CMC documentation is eCTD compliant, eCTD filenames assigned, Document formatting (DA) checked, PDF properties are compliant for eCTD submission, documentation is finalized and eCTD file names assigned Coordinate data/KPIs required for reports within RA CMC Support project teams for document finalization, collate ancillary documents requirements from various sources (e. g. databases, OneNote, trending etc. ) and support coordination and management through the appropriate system Coordinate, prepare and track CMC submissions for delivery to RA Operations Perform super-user role of RA CMC documentation system/ support super-user for e. g. account requests/ modifications as assigned Acquire and maintain GMP Certificates and Manufacturing Authorizations required for RA CMC submission in the Document Management System Support other GSOC team members for end-to-end submission coordination Key performance indicators: High quality regulatory submissions and operational documentation Timeliness of deliverables: No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate CMC documentation and compliance support on matters within RA CMC control Timely and accurate information / communication about operational and compliance issues within own department and to key stakeholders Ensure that the operational activities and CMC regulatory documentation follow Novartis and eCTD guidelines. Regulatory compliance met in all compliance systems Build and maintain collaborative partnerships with stakeholder Partner with other GSOC team members to ensure business continuity Minimum Requirements: Work Experience: If University entrance or completed vocational training: Preferably 2 years in regulatory and/or experience in the pharmaceutical industry If Science Degree: Preferably 1 year in regulatory and/or experience in the pharmaceutical industry Working experience in pharma industry data systems and data management Ability to work successfully with global project teams and prioritize activities considering timelines and workload Effective planning, organizational and interpersonal skills Prior publishing experience desired Computer literacy/IT systems literacy: Excellent data processing skills Skills: Being Resilient Digital & Technology Savvy Continuous Learning Interpersonal Savvy Operational Excellence Project Excellence Education: Minimum: General qualification for university entrance or completed vocational training Desirable: Science Degree (e. g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent Languages: Fluent English required (oral and written). Good written/spoken communication skills 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:

Summary Perform and document scientific experiments in the laboratory for drug substances (DS) and drug products (DP) in collaboration with multifunctional project teams. Contribute to maintenance of lab instruments/day-to-day operations. Timely execution of project related activities to support TRD-NCE strategies and goals. About the Role Major accountabilities: Plan, organize, execute, and document scientific experiments (e. g. , analytical method developments/ validations/ transfers/ stability/ release testing, formulation development analytics etc. ) according to the agreed timelines and appropriate quality standards. Accountable for documentation and submission of raw data in appropriate data system (for e. g. , LIMS test activation and results entry). Responsible for good documentation practices (GDP) and good laboratory practices (GLP) during execution of laboratory activities. Support in evaluation and interpretation of results including investigations on SST failures, OOX/Deviations/Change controls as needed. Responsible for assigned laboratory related area/activities (e. g. , chemical / reagents / consumables / samples / column / glassware management etc. ). Responsible for implementation and maintenance of lean/efficient/environmentally sustainable practices in the laboratory. Proactively communicate key issues and any other critical topics in a timely manner to the manager and/or to any other relevant project team member(s). Responsible to meet KQI (Key quality indicators) and KPI (Key performance indicators) for all assigned activities. Support internal and external audits and ensure no critical findings within the assigned scope. Actively contribute to team and organization goals. Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISRM & Novartis Guidelines. Additional specific roles/tasks: See Up4Growth training assignments for the business roles for the associate as per the team matrix and completion of trainings in transcript of learning system (e. g. , Up4Growth). Minimum Requirements: Masters in Life Science (e. g. , analytical / organic chemistry /pharmacy / pharmaceutical development) or equivalent. 5+ years of relevant work experience in OSD forms- hands on in chromatography, multimedia dissolutions, In-vivo & Invitro dissolutions, quality investigations, QBD etc. Fluent in English (oral and written). Knowledge of site language, if required. Knowledge in quality principles driving drug development such as GMP. Understanding of general regulatory and quality expectations. Good scientific background, communication skills including presentation and scientific/technical writing. Work Experience: Functional Breadth. Operations Management and Execution. Collaborating across boundaries. Skills: Environment. Experiments Design. Health And Safety (EHS). Laboratory Equipment. Manufacturing Process. Materials Science. Process Simulation. Project Management. Sop (Standard Operating Procedure). Technical Writing. Languages : English. 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:

Protectron Electromech Pvt. Ltd. is looking for Quality Executive to join our dynamic team and embark on a rewarding career journey. Understand customer needs and requirements to develop effective quality control processes Devise and review specifications for products or processes Set requirements for raw material or intermediate products for suppliers and monitor their compliance Ensure adherence to health and safety guidelines as well as legal obligations Supervise inspectors, technicians and other staff and provide guidance and feedback Oversee all product development procedures to identify deviations from quality standards Inspect final output and compare properties to requirements Approve the right products or reject defectives Keep accurate documentation and perform statistical analysis Solicit feedback from customers to assess whether their requirements are met Submit detailed reports to appropriate executives Be on the lookout for opportunities for improvement and develop new efficient procedures

IVL India Environmental RD is looking for Quality Expert to join our dynamic team and embark on a rewarding career journey. Develop and implement quality assurance policies and procedures. Conduct quality audits and inspections. Analyze data to identify areas for improvement. Provide training on quality standards and processes. Ensure compliance with regulatory requirements.

IVL India Environmental RD is looking for CAD Operators to join our dynamic team and embark on a rewarding career journey. Operators play a vital role in ensuring the smooth operation of various systems and processes within an organization They are responsible for monitoring equipment, performing routine maintenance tasks, and responding to any issues that may arise during operations Here's a detailed breakdown of their responsibilities:Key Responsibilities:Monitor Equipment: Operators are responsible for monitoring various types of equipment, such as machinery, production lines, or computer systems, to ensure they are functioning properly Perform Routine Maintenance: Operators perform routine maintenance tasks on equipment to ensure optimal performance and prevent breakdowns This may include cleaning, lubricating, and adjusting machinery as needed Troubleshoot Issues: When equipment malfunctions or operational issues arise, Operators are responsible for troubleshooting the problem to identify the root cause and implement solutions to resolve it promptly Ensure Safety: Operators adhere to safety protocols and procedures to maintain a safe working environment They may conduct safety inspections, implement safety measures, and respond to any safety concerns or incidents Maintain Records: Operators maintain accurate records of equipment performance, maintenance activities, and any issues encountered during operations This documentation is essential for tracking maintenance schedules and identifying trends or recurring issues Coordinate with Team Members: Operators collaborate with other team members, such as maintenance technicians, supervisors, and quality control personnel, to coordinate activities and address operational needs effectively Follow Standard Operating Procedures (SOPs): Operators follow established standard operating procedures (SOPs) and guidelines to ensure consistency and compliance with industry regulations and quality standards Continuous Improvement: Operators actively participate in process improvement initiatives by providing feedback, suggesting improvements, and implementing best practices to enhance operational efficiency and effectiveness

Jubilant Life Sciences Limited is one of the Indias leading corporate and a highly treasured brand throughout the world. The organization has a presence in the fields of Pharma and Life Sciences, Agri & Performance Polymers, Food & Retail, Oil & Gas and Services. Jubilant Life Sciences Limited is an integrated global pharmaceutical and life sciences Company engaged in Pharmaceuticals, Life Science Ingredients and Other businesses including Drug Discovery Solutions and India Branded Pharmaceuticals. The Pharmaceuticals segment, through its wholly owned subsidiary Jubilant Pharma Limited, is engaged in manufacturing and supply of APIs, Solid Dosage Formulations, Radiopharmaceuticals, Allergy Therapy Products and Contract Manufacturing of Sterile Injectable and Non-sterile products through 6 USFDA approved manufacturing facilities in the US, Canada and India and a network of over 50 radio-pharmacies in the US. The Life Science Ingredients segment, is engaged in Specialty Intermediates, Nutritional Products and Life Science Chemicals through 5 manufacturing facilities in India. The Drug Discovery Solutions business, provides proprietary in-house innovation & collaborative research and partnership for out-licensing through 2 world class research centers in India. Jubilant Life Sciences Limited has a team of around 7,700 multicultural people across the globe and is committed to deliver value to its customers across over 100 countries. The Company is well recognized as a Partner of Choice by leading pharmaceuticals and life sciences companies globally. Ranked No. 6 amongst top 10 Global Pharmaceutical outsourcing players as per UNCTAD World Investment Report 2011 Reputed and High Quality relationships with 19 out of the top 20 Pharmaceutical companies, and 6 out of the top 10 Agrochemical companies globally Vision To acquire and maintain global leadership position in chosen areas of businesses To continuously create new opportunities for growth in our strategic businesses To be among the top 10 most admired companies to work for To continuously achieve a return on invested capital of at least 10 points higher than the cost of capital. Our Promise We will, with utmost care for the environment and society, continue to enhance value for our customer by providing innovative products and economically efficient solutions; and for our stakeholders through growth, cost effectiveness and wise investment of resources. Kindly refer www.jubl.com for more information about organization. Position Executive / Sr. Executive- QC Grade : A3 A4 Business Unit / Function Department Quality Control Location Bharuch SEZ Reports to Lab In charge-QC Summary of Job (Purpose/ objective of the job Department Organogram to be enclosed) candidate is required having complete experience in API/Bulk/ Intermediates industries as per global regulatory requirements and responsible for implementation & compliances of ICH-Q7A, cGMP, WHO-GMP, ISO9001, FSSC, HACCP / global QMS requirements at SEZ site. Key Responsibilities (Performance Indicators) Knowledge about IMS system (ISO 9001:2015, ISO 14001:2015 OHSAS 18001:2007, and cGMP, USFDA, FSSC -22000, NABL Analytical skill for QC instrument, i.e. GC-HS, UPLC, HPLC, UV-Visible, FTIR, ICP, K/F, Melting point etc. Regularize the QC activities as per cGMP requirements. RM, PKG, In-process and FG sampling & Analysis. Co-ordination with QC staff, R&D, Commercial and production for quality & dispatch related activities for on time dispatches. Day to day monitoring and execution online all IPQC and FG analysis activities. Resolve the trouble shooting related to QC instruments & activities. Knowledge about 21 CFR Part 211, 111 with data integrity (Part-11), 217 Awareness about responsible care (Environment, Health, Safety and Security) Documentation work SOP Preparation, MOA Preparation, Investigation. No. of Reportees Qualification & Experience M.Sc. (Chemistry) with 2 - 6 yrs. Key Competencies (Technical, Functional & Behavioral) Handling, Calibration and Hand-on experience of all QC instruments. Compliance of 21 CFR Part-11. Troubleshooting related to QC analytical instrument

Strict adherence to cGMP norms and safety rules of the factory. Maintain workplace neat & clean. Updating GMP documents regularly. Raw material issuance & Document Entries as per SOP Keep up-to-date Stock for Receipt &Issued material. Maintain Physical Stock. Vs SAP stock accurate. Inventory management of all Warehouse Related Raw materials. Support for preparation of reports such as Rejection reports, Retest Reports, Receipt. Reports, MIS Reports and Cross check with relevant documents its correctness in SAP. Support for Job work SAP entries posting and monthly stock reconciliation. Insure timely submission GRN & Retest note for all Raw materials adhering to SOP. Manpower Management of all Casual labors. Physical Stock Verification of all Raw materials and Reconciliation and Monthly Variance correction. Over all control of all warehouse activities with time management. Any other job assigns by department head. Bachelors in Chemistry (B.Sc) / Diploma in Chemical.

Business: Pharma Solutions Department: Engineering Location: Digwal Travel: NA Job Overview To maintain the GMP & EHS Documentation related to E&M Key Stakeholders: Internal Production, QA, EHS Key Stakeholders: External Regulatory, Customer Reporting Structure AGM - E&M Positions that report into this role Executive/ Sr. Executive / Dy. Manager Experience 12 years and above Job Description: Responsible for carrying preventive maintenance as per schedule. Should be capable of handling Quality, EHS Audits. Should have in-depth knowledge in cGMP/USFDA Documentation Should have in-depth knowledge in Current safety systems/safe working practices. Person should be capable to Train & lead the Team Should be familiar with online GMP documentation. Should be familiar with Root cause Analysis tools. Should have in-depth knowledge on Equipment Qualification, Preventive maintenance documentation, ISO documentation, SAP knowledge. Responsible for preparation of SOP s, HVAC protocols and validation reports. Should be familiar with Change controls, Deviations, Risk assessments Should be familiar with process equipment like Reactor, centrifuge, ANFD, RCVD, Blender, sifter, multi mill, FBD etc Should be familiar with Utility equipment like Boiler, Air compressor, nitrogen plant, chillers Responsible for preparation of all types of schedules and follow-up with user departments Responsible for Audit compliance, CAPA closing. Co-ordination with QA, production, EHS and Engineering team. B.E/B.Tech (Mechanical)

Duties & Responsibilities : Lead factory quality team and work cross-functionally to ensure that all products meet company standards and regulatory requirements. Oversee the implementation, maintenance, and improvement of the Quality & Food Safety Management System and other relevant food safety standards. Lead internal and external audits to ensure compliance with industry standards and regulatory requirements. Lead food safety risk assessments and develop corrective action plans in response to non-conformances or audit findings. Oversee the inspection and testing of raw materials and packaging materials supplies upon receipt to ensure they meet specifications. Oversee the daily operations of the QC lab, ensuring timely and accurate testing of raw materials, in-process samples, and finished products. Implement and oversee real-time quality control checks at various stages of the production process to ensure products meet predefined quality standards. Utilize data-driven approaches such as SPC, Six Sigma, or Lean methodologies to drive improvements in quality performance. Implement quality control charts and visual management tools to monitor process performance and highlight any variations in real-time. Lead root cause investigations and collaborate with operation teams to resolve in-process quality issues promptly. Lead the integration of digital tools and platforms to streamline quality management processes, including document control, audit management, CAPA (Corrective and Preventive Actions), and compliance tracking. Develop and maintain digital dashboards for real-time monitoring of key quality metrics (KPIs), enabling quick decision-making and transparent communication across the organization. Foster a strong quality-first mind set across all levels of the organization, emphasizing the importance of food safety and quality in every task. Develop and implement training programs aimed at increasing awareness of food safety, quality standards, and regulatory compliance among all employees. Create opportunities for employees at all levels to participate in quality initiatives, such as quality circles, Kaizen events, and suggestion programs. Address customer complaints related to product quality and implement solutions to prevent recurrence.

Job Location: Baramati Company description Ferrero is a family-owned company with a truly progressive and global outlook and iconic brands such as Nutella , Tic Tac , Ferrero Rocher , Raffaello , Kinder Bueno and Kinder Surprise . As the love for our brands continues to grow, so too does our global reach. Represented in more than 50 countries, with products sold in more than 170, the Ferrero Group is loved by generations around the world. The secret to our global success? 40,000 dedicated employees who celebrate care and quality to craft a business, careers and brands we are proud of. Join us, and you could be one of them. Diversity Statement About the Role: In this position you will coordinate and organize maintenance activities in shift to ensure the plants workability (devices) and the highest level of reliability and efficiency of production lines. To supervise/coordinate all technical interventions in production machines. To involve in all maintenance activities by respecting maintenance policies. Shift Officer - Mechanical Main Responsibilities: 1. Shift coordination with technicians & production 2. Maintenance polices realization (Preventive, corrective, predictive Maintenance) MAINTENANCE POLICIES Maintenance Policy Execution: cooperates with Maintenance Technique Responsible (shift officer) in the evaluation of the maintenance Definition cooperates in data collection and analysis needed for the evaluation of potential changes to maintenance policies. INTERVENTION EXECUTION Maintenance Practices: supports in the spreading of best maintenance practices. Safety: ensures the correct application of safety standards and safe behaviors during the execution of maintenance intervention PM implementation: guarantees the correct implementation of preventive maintenance actions, including also, that focused-on improvement and condition-based. Corrective Maintenance: to coordinate with Technicians, corrective maintenance activities on production machinery as per notifications requests from production . Spare parts: guarantees all the necessary spare parts for the maintenance intervention. Professional Maintenance: To adopt the way of working for Smart factory Maintenance (SAPPM, Mobile Maintenance, Digital SIM etc.) To coordinate and execution of Periodic maintenance program (Major overhauling /periodic revisions) To support during new machine installation/upgradations in production lines DOCUMENTATION MANAGEMENT To take part in the update and archiving of machinery books, operative manuals, and other ISO documentation. CONTINUOUS IMPROVEMENT To work for achieving Maintenance KPI indicators, analyses & understanding areas for improvement both at maintenance system as a whole and at equipment / machinery level MONITORING AND ACCOUNTING Manpower: To handle the team of technicians and guarantees the correct in-systems management. Breakdown Analysis: takes part in the breakdown root cause information collection and analysis in order to detect and implement improvements. SAFETY AND HYGIENE Orderliness, cleanliness, maintenance guarantees that all the maintenance activities are done respecting Good Manufacturing Practices (GMP) TRAINING To manages and executes trainings to production resources focused on Autonomous maintenance (basic regulation, size changes) To manages and executes training on specific topics to collaborators Who we are looking for: EDUCATIONAL BACKGROUND : BE/B. Tech EXEPRIENCE : 5-7 years SPECIFIC KNOWLEDGE/REQUIRED SKILLS : Knowledge on rotary equipments ,Gearbox, lifting mechanism , Refrigeration systems ,conveyors blenders,refiners ,ovens & Heating systems Knowledge pnumatic & hydrallic systems Knowledge on Food safety Management system, Computer Proficiency (SAP,Office,etc..) Mechanical Maintenance experience in FMCG/ process/Packing machinaries Job Referral Code : C How to be successful in the role and at Ferrero: Consumers, quality and care are at the heart of everything we do. So, to be successful at Ferrero, you ll need to be just as consumer and product centric as we are - dedicated to crafting brilliant results for consumers around the world.

Department: Analytical Development Injectables / Complex Injectables US Market Job Description: Method Development of Drug Product and Method verification of Raw Materials using HPLC, UHPLC with sound knowledge of Chromeleon & Lab solution software. To perform analysis of Drug Product and Drug Substances for various test parameters and as per the product development requirement. Compilation of analytical results and preparation Method Development Report. Literature survey to support method development of Drug product and characterization activity of Drug product. Compilation and monitoring of routine and stability analysis data. Support to formulation team to develop the drug product.

To Maintain the machine and work place clean in all respect. Carry out all activities in area with required status labelling procedure as per SOP. To maintain overall cGMP and GDP in department. To impart training and evaluation of company employees. Preparation of SOP, BPR and Validation Protocol. Handling of deviation, incident, change control and CAPA. Responsible for all activities carried out in shift. To ensure availability of secondary packing material for packing activities. Responsible to ensure dispensing, equipment cleaning, visual inspection, vial labelling, cartonator machine,online Responsible for in process Packing activities and Finished good activities as per SOP. Planning and participation in validation of equipment. Report to Department head regarding any process or operation related problem. Manpower planning and allocation of work according to their skill.

Method development & Validation ( HPLC /GC/ UV/ Potentiometer etc..) for both Solid orals and Injectables & Handling of all analytical instruments/ Equipments, SOPs prepation, SPEC and STPs prepation/ review,Stability samples analysis .

Lead the development and formulation of new pharmaceutical products, ensuring they meet regulatory standards and quality guidelines. Conduct research and feasibility studies to identify potential products and improve existing formulations. Formulate and test different dosage forms, including tablets, capsules, liquids, and topical products. Develop and optimize production processes, ensuring scalability, efficiency, and cost-effectiveness. Collaborate with R&D, quality control, and manufacturing teams to ensure smooth product development and transfer to production. Prepare and review documentation for regulatory submissions, including stability data and product specifications. Ensure compliance with Good Manufacturing Practices (GMP) and other regulatory standards in product development. Troubleshoot formulation issues and address challenges related to solubility, stability, and bioavailability. Monitor and evaluate the performance of products post-launch, gathering feedback for future improvements. Stay updated on industry trends, competitor products, and technological advancements in pharmaceutical development.

Requirement is for a dynamic young man having 3 to 7 Years experience in store management of a Pharmaceutical Formulation manufacturing Company for bulk Packaging Material . Added qualifications for Stores Management will be an advantage for consideration. The candidate should have complete knowledge of GMPs GLP and Good Storage Practices. Packing material receiving & update document Material Inward, checklist, GRN, Material arrange location wise etc. Experience: 3 to 7 Years (B.Pharma Candidate preferred Graduate) Age: Maximum 35 Years

Key Responsibilities: Manage the overall Quality assurance and Quality Check of products Responsible to ensure that that all products meet the highest standards of quality, safety, and regulatory compliance for a new Trade Generics business Work closely with the senior advisor & procurement manager for QA/QC of contract manufacturers & final products Initially report to promoter and later to Ops & Supply Chain Head Experience 5+ years of experience as a quality manager/ executive in the pharmaceutical industry, with strong knowledge of regulatory standards is must. Relevant roles: Quality Manage/ Quality executive of a pharmaceutical company Experience with leading the audit/ inspection/ regulatory compliance efforts with contract manufacturers, for a new pharmaco is preferred. Role & Responsibilities Inspection & Audit of contract manufacturers : Quality Oversight Ensure that select CDMOs comply with GMP, ISO standards, and other regulatory guidelines applicable to the pharmaceutical industry Conduct regular audits Ensure batch reviews & quality controls throughout the production process Product Quality Assurance: On site Conduct extensive QC and batch reviews for product on the CDMO manufacturing site Off site Conduct product reviews after receipt at warehouse Regulatory Compliance & Documentation : Drive regulatory compliances in terms of product & process quality; liaison with respective regulatory bodies Documentation - Proper documentation and compliance with product quality requirements for regulatory submissions and inspections Additional Information Ensure product quality and regulatory compliance for a new Trade Generics business. Collaborate on QA/QC of CDMOs and final products. Conduct audits, inspections, and product reviews. Ensure regulatory compliance and documentation. 5+ years of pharmaceutical QA/QC experience with regulatory expertise.

Knowledge on Regulatory guidelines for API & Finished product registration. Preparation, Review and submission of Technical documents/Dossiers (CTD/ACTD) for Regulatory and Non Regulatory Markets. Gap analysis of the dossier and addressing the gaps before submission to MOH. Handling of customer and MOH queries. Coordination with cross-functional teams & Reviewing of Documents (Specification, MOA, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). Post approval experience to file the applicable variations timely. Knowledge on EAEU, ICH and EMEA guidelines. Re-registration (Renewal) procedures. Should have hand on experience in handling ODLS, FSSAI, Sugam Portal for Licensing of Drug & Food Products. Prior knowledge on Administrative document applications (COPP, GMP, Free sale and Import License). Registration information management system updates on regular basis. Requirements Bachelors/Masters degree in Biotechnology/ Microbiology/ Pharmacy/ Regulatory Affairs. 1-4 Years of experience as Regulatory Affairs Executive in Pharmaceuticals. Interpersonal and communication skills Planning and organizing skills

Role & responsibilities: Killed Vaccine production as per planning. Operate and clean production equipment (CIP/SIP) and maintain logs as per cGMP guidelines. Coordinate with QC department regarding results Prepare and maintain Batch Manufacturing Records (BMRs) and deviation reports Collaborate with QA/QC, Engineering, and Validation teams during audits and batch reviews Support scale-up and technology transfer activities for killed vaccine processes. Job Location: Kadi,Gujarat (Bus transport facility available from Ahmedabad, Kalol & Kadi)

Role & responsibilities: Killed Vaccine production as per planning. Operate and clean production equipment (CIP/SIP) and maintain logs as per cGMP guidelines. Coordinate with QC department regarding results Prepare and maintain Batch Manufacturing Records (BMRs) and deviation reports Collaborate with QA/QC, Engineering, and Validation teams during audits and batch reviews Support scale-up and technology transfer activities for killed vaccine processes. Job Location: Kadi,Gujarat (Bus transport facility available from Ahmedabad, Kalol & Kadi)

To Prepare sample for the determination of heavy metals, micro minerals and minerals in Food and Agriculture samples as per ISO, IS and Customer specific requirements adopting test methods ISO, AOAC and IS methods using Microwave digestor. Maintenance of standard Reference Materials, Chemicals, Reagents and Glassware used in the laboratory. Responsible for all the instruments related to Metal analysis. Maintaining samples; before, during and after analysis. Qualifications 3-4 years experience of working in food testing laboratory. Proficient in handling ICP-MS and method validation for heavy metals analysis Graduate B.Sc/M.Sc in Chemistry Additional Information Good interpersonal and communication skills. Energetic, flexible and innovative. Able to work independently and to coordinate several activities simultaneously. Good in communication, read and write in English and local language. Acts quickly and decisively. Knowledge in Microsoft Office (such asMicrosoft Word, Excel, Power Point, & etc.),

Eurofins Scientific is an international life sciences company that provides a wide range of analytical testing services to clients across multiple industries. From food and pharmaceuticals to environmental and cosmetic products, Eurofins ensures safety, authenticity, and accuracy. With a global presence and over 900 laboratories, Eurofins is a leader in food, environmental, pharmaceutical and cosmetic product testing, as well as in genomics, clinical studies support, and other specialized diagnostic testing. The Project Manager Assistant (PMA) position is an administrative role working directly with a group of Project Managers, focusing on a specific area of the business. This role requires the use of technical functions to navigate Eurofins Lancaster Labs (ELLI) information systems, construct and develop relationships with ELLIs internal scientific and support departments, and assist project managers with a variety of tasks to allow the PMs to focus on client communication. Please note that this position does require direct client interaction. This is a great role if you also aspire to move into a PM position in the future. Employee Responsibilities: Support Sample and Project Management in building and maintaining studies including entering and review of material items, study start and end dates, and generating project plans for the PM teams. Managing incoming and in house Reference Standards by reaching out to the client for updated CoAs when expirations are approaching. Working with Pricing and Analytical Definition to generate quotes and build templates for sample entry of incoming samples. Track financial aspects of projects including purchase order and invoice management. This may also include generating Change Orders, special invoice requests and potentially End of Month billing for clients that qualify. Support Project Managers in an administrative capacity with a variety of other assignments Qualifications M. Pharm / M.Sc, Analyitical Chemistry PMP certification would be an additional advantage Additional Information Experience Level : 5 - 7 years in Bio/Pharmaceutical Analysis Key Candidate Attributes: Possesses excellent communication skills both oral and written Has a strong organization and attention to detail Computer skills Experience utilizing MS Office and MS Project or other project organization tools. Experience navigating a LIMS or equivalent is a plus Ability to learn new techniques, perform and prioritize multiple tasks simultaneously, keep accurate records, follow instructions, and comply with agency and company policies (GMP knowledge is a plus) Ability to work both independently and as part of a team, be self-motivated, adaptable, and maintain a positive attitude, even with critical deadlines Initiative/ Self-Starter proactively seek out work and training opportunities, offer to assist others, strive for high productivity and output in a fast-paced environment

Please find the JD below. Planning and traveling for Food Safety audits Conducting Food Safety Audits as per FSSAI Schedule 4 requirements Generating the audit reports Submission of Audit Pack. Correction of audit reports as per technical review process Qualifications Minimum B.Tech/BE/B.SC- Food sciense/Biotech/Foodtech/Food processing/Dairy Tech etc. Minimum 2-3 years of experience in the industry Candidates having ISO/FSSC 22000 lead Auditor certification and Minimum 20-30 audits experience, will be given preference. Additional Information

Job Location:Kochi, Bangalore/Chennai/Hyderabad Job Scope and Accountabilities: To conduct audits/ Trainings as per the requirements stated in audit criteria To remain updates on all skill development, code qualification, Regulatory and Industrial requirements related to audits and certifications. To be competent and qualified in Various standards like BRCGS food, packaging, FSSC, ISO 22000, GMP etc. Upgrade the knowledge of local social, economic, and business environment. To ensure TAT- Turnaround time for audit reports as per procedures established by Eurofins. Supervisory Responsibilities: Mentoring & Support of Technical executives, Auditors / Back office executives. Monitoring and support to Operational activities. Duties: To understand the role of impartiality when providing certification activities and the process of taking independent action where necessary, (e.g. informing authorities, accreditation bodies, stakeholders) To demonstrate the management expertise and ability to lead and take decisions. Review the decisions taken by technical manager relating to certification/verification. To demonstrate the ability to communicate with all stakeholders (e.g. Impartiality Committee, Directors) To ensure timely updating of qualifications and competency, satisfactory completion of training, calibration meetings, training audits, witness audits and approvals. Qualifications Bachelors degree in appropriate discipline Preferably Food Science Lead auditor course FSMS/ FSSC /QMS or equivalent Minimum 5 year of experience in Operations, technical, Audits, preferably from a CB company. Minimum 4 years of experience in food industry preferably production or quality department. Additional Information Good at Communication Skill. Good at Presentations Good command on written and spoken English High leadership and supervisory skills Result oriented Problem solving Good at Retention Good at operating Microsoft Office. Proficiency in English. Customer Relationship management system (CRM) Professional Behaviour.