1756 Gmp Jobs - Page 21

The Executive - Production position at Dishman Carbogen Amcis Limited in Bavla, Gujarat, India, requires you to be proficient in Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). You will also be responsible for participating in audit preparation for regulatory agencies. Additionally, knowledge of HAZOP study and process safety is essential for this role. This position falls under the Industrial, Law, Manufacturing, and Legal job segment.,

As an Intern at Graviss Food Private Limited, your day-to-day responsibilities will include: - Sampling and analyzing finished products (ice-cream) and semi-finished products to ensure quality standards are met. - Ensuring the quality of raw material, packing material, and finished food products by conducting regular inspections. - Inspecting plant hygiene and personal hygiene practices to maintain a clean and safe working environment. - Conducting Good Manufacturing Practices (GMP) and Good Hygiene Practices (GHP) training sessions to educate staff on best practices. - Documenting online production line activities, all chemical testing reports, training sessions, and other relevant documents for record-keeping. - Working in third-party production as a Quality Assurance (QA) and production officer to oversee quality control processes. About Company: Graviss Food Private Limited is the exclusive licensee of Baskin Robbins, the world's favourite ice cream brand, in India and South Asia. Since 1993, it has delighted millions with premium ice creams, cakes, and desserts, offering a variety of flavours tailored to diverse tastes. With a strong franchise network, Baskin Robbins outlets are present across major cities, and its products are widely available in supermarkets and online platforms. Graviss Foods prioritizes quality, hygiene, and sustainability, establishing itself as a market leader in the ice cream segment. Committed to excellence, Graviss Foods continues to deliver happiness, one scoop at a time.,

As a Quality Control (QC) Officer at our molecular diagnostics manufacturing team in Pune, you will play a crucial role in ensuring product quality and compliance with industry standards. Your responsibilities will include conducting quality control tests, performing molecular diagnostic assays, maintaining laboratory equipment, documenting test results, and collaborating with various teams to address quality issues. You will be required to have a Bachelor's degree in biotechnology, molecular biology, biochemistry, or a related field, with 1-5 years of experience in quality control within the molecular diagnostics or biopharma industry. A strong understanding of molecular diagnostic techniques, assays, and instrumentation is essential, along with excellent attention to detail and accuracy in test performance and result documentation. Your role will also involve ensuring compliance with Good Manufacturing Practices (GMP), ISO standards, and regulatory requirements, as well as monitoring quality control data trends for improvement opportunities. Additionally, you will be expected to provide training and guidance to junior QC staff, maintain a clean laboratory environment, and adhere to safety protocols. In return, we offer a competitive salary and benefits package, opportunities for career growth and professional development, a collaborative work environment, and access to state-of-the-art laboratory facilities and equipment. Join our team and contribute to the advancement of molecular diagnostics manufacturing while honing your skills and expertise in the field.,

Manage the Quality Assurance function at manufacturing site Ensure compliance with ISO, GMP & REACH standard Develop, implement & monitor Quality Management Systems including SOPs, documentation & CAPA systems Handle customer complaints, conduct RCA Required Candidate profile 10-12 years of experience in QA, preferably in specialty chemicals Knowledge of analytical instruments, QC processes & technical documentation Strong knowledge -ISO 9001, GMP & other quality standards

You will be accountable for managing the Engineering Function to advance developments that align with business goals for the Manufacturing Units. Your responsibilities will include overseeing the development and execution of a strategic plan and annual investment plans (OpEx and CapEx plans). This will involve ensuring efficient Utility Operation, implementing Good Maintenance/Engineering Practices/Programs, mechanization & automation for lean structure, technology improvements, and expansions. Additionally, you will be required to embed a safety-first culture throughout the organization and support overall safety initiatives, ensuring compliance with relevant standards, policies, and procedures related to personal and food safety, quality, and environmental regulations. The ideal candidate for this role will be an Engineering Graduate (Mechanical / Electrical) with a minimum of 10-18 years of experience, including at least 4-5 years in leading Engineering & Maintenance functions at the plant level. You should have hands-on experience in leading engineering and maintenance functions, budget management and control, failure analysis and troubleshooting, as well as personnel management and development. Previous experience in food processing or allied industries will be preferred, along with experience in working with Indian Business Groups. Your key responsibilities will include safeguarding compliance with asset management standards and policies in both engineering and maintenance to ensure safe, reliable, and efficient performance for optimizing technical availability of manufacturing assets. You will also be responsible for developing people within the engineering functions, ensuring proper resource and succession planning, and overseeing equipment design, selection, installation based on a life-cycle philosophy. Additionally, you will lead maintenance and utilities operations, provide technical leadership in engineering practices, and identify & implement new technologies for productivity and energy efficiency improvements. Furthermore, you will spearhead the development and implementation of mechanisms for the smooth operations and maintenance of centralized engineering services, in compliance with GMP and regulatory requirements. Your role will involve maintaining plant assets, ensuring uptime of production equipment within annual budgets, and leading an engineering team comprising executives and technicians from mechanical, electrical, instrumentation, safety, and engineering project streams. You will also be responsible for initiating, designing, and developing capital expenditures for the plant to achieve planned new product developments each year. Moreover, you will establish systems for condition monitoring, predictive & preventative maintenance, trouble shooting failures, and failure analysis. You will provide technical resolution to overcome issues during equipment installation, commission compressors and pumps in a controlled manner, and work towards achieving plant safety targets (ZERO accidents) across all units in India. Ensuring that project engineers / managers are aware of relevant HACCP, ISO, GMP, workplace safety, environmental, and safe work procedures will also be part of your responsibilities to ensure project safety during and after completion.,

The role of Calibration Technician/Engineer involves carrying out calibration activities at various sites across India and abroad. Your main duties will include executing calibration tasks for a range of equipment including computerized systems, plant equipment, laboratory equipment, facilities, utilities, and process control systems. These calibrations will be conducted to support GMP/FDA requirements for our clients. The ideal candidate for this position should have prior experience in providing calibration services. The job is based in Vasai, with travel required to different locations for on-site calibration work. As a Calibration Technician/Engineer, you will play a crucial role in ensuring that all equipment and systems meet the necessary calibration standards. Your attention to detail and ability to work in compliance with regulations will contribute to the success of our calibration department.,

Developing production schedules and plans to meet customer demand while optimizing the use of resources such as labor, materials, and equipment. Meet quality standards. Responsible for Inventory management, production cost, process improvements. Required Candidate profile BE/B Tech Mechanical with 15-20 yrs of exp in manufacturing industry preferably in minerals processing , cement industry or likes for at least 5 yrs as a Plant Head. Hands on in LEAN/KAIZEN/GMP’s/ISO

Efficiently monitor all operations which affect the quality. Devise procedures for inspecting and reporting all the persisting quality issues. Assure the consistency and reliability of production with thorough checking procedures and final output. Supervise and guide inspectors, technicians, and all other staff. Report all malfunctions to production executives only to ensure immediate action. Appraise all the requirements of customers and ensuring they are quite satisfied. Facilitate proactive solutions by collecting and analyzing quality data. Keep permanent records of quality reports, statistical reviews, and relevant documentation. Review the current standards and policies. Communicate with external quality assurance officers during on-site inspections. Efficiently ensure that all the legal standards are met with great care. Provide assistance during the recruiting process. Efficiently create reports for tracking progress.Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications. Perks and benefits: Mention available facilities and benefits the company is offering with this job.

Job Description To ensure all the products manufactured and distributed by the bottling operation conform to the specifications through assurance of processes from supply to consumer. The QAE supports the identification, planning, documentation, and management of the practices, activities and resources needed to meet quality goals and objectives in a manner that enables management to assess quality performance. Job Responsibilities Responsibility for all quality management, and quality assurance activities in the bottling operation. Responsibility for adherence to Company guidelines and requirements in the supply, manufacturing and distribution processes. Responsibility for the conformance to specifications of the finished goods leaving the plant. Responsibility to monitor, assess and improve process capabilities in the plant Responsibility for conducting the required tests on raw materials, packaging materials, WIP and finished product at the specified frequencies. Responsibility for availability and calibration of inspection and testing equipment and chemical reagents. Responsibility for process control of the final syrup, water treatment Responsibility for raw material, ingredient and product identification and traceability. Responsibility for the implementation of GMP in the plant. Responsibility to document, implement and monitor a quality assurance system in accordance with the KORE Requirements. - Commitment to Development Commitment to Excellence Teamwork Planning and Execution Influencing Knowledge of the Business Job Requirement Minimum Education: Post Graduate in Microbiology. Minimum Experience: 2 - 3 years in a Microbiology in beverage industry.

Job title: Mat. & Doc. Flow Manager Work Mode: Hybrid Location : Hyderabad About the job Our Team: The CMC (Chemistry, Manufacturing, and Controls) Demand and Supply Hub serves as the critical link between product development and market delivery, ensuring seamless coordination of supply chain activities to meet patient needs worldwide. We transform scientific innovation into reliable, high-quality pharmaceutical supply through strategic planning and operational excellence. Main responsibilities: The mission of the CMC Material & Documentation Flow Platform is to support the efficient coordination of Drug Product (DP) and Marketed Products (MP) transfer and receipt to sustain clinical and non-clinical development. Projects & scope: All products under the responsibility of the CMC Integrated Demand & Supply team Supports CMC Integrated Demand and Supply team in the management of material and documentation requirements for shipment and receipt of products (drug products or marketed products) under the accountability and supervision of / and the timelines defined by Demand & Supply Leader assigned to a given project. This includes Providing Material Flow Management (MFM) services: Create and maintain material codes in ERP systems Execute ERP transactions (Purchase Orders and Transfers Orders), Coordinate Drug product transfer from manufacturing facilities to packaging facilities Oversee Drug Product (DP) flow management for Contract Manufacturing, Organization (CMO) Packaging, Coordinating and execute Drug Product destruction plans Provide technical support for Qualipso events management (including CMO/FSO) (e.g.,temperature excursion management, deviation handling) Filling product documents such as (but not limited to): Product Information Document (PID), Drug Product Study Document (DPSD), Traceability reports, Technical Conditions for DP shipments. Filling products data in D&S tools such as (but not limited to) COMPASS, Demand Owner Module, RDPM, Request product documents to the appropriate owners as prerequisites for DP handling such as (but not limited to) TOR, quarantine and shipment authorization, CoR/CoA, Provide support in documentation management in compliance with regulatory requirements: US customs documentation, CN customs requirements definition, French Import License request form preparation and tracking Support operational planning activities by providing DP schedule information to CSC About you Experience : At least 2 years of work experience in supply chain, CMC, clinical fields, pharma R&D, Good Knowledge of Global Exports and Imports is a plus. Good communication skills, Ability to work in a Global Team environment Knowledge on Process Mapping and Continuous Improvement Strong knowledge of Pharma Product Manufacturing/Packaging Strong knowledge of CMC and Clinical Supply Chain processes and deliverables Strong knowledge of ERP systems, Excellent oral and written communication skills Proficiency in written and spoken English is required to interact with multiple interfaces worldwide, Good to have spoken and written proficiency in French but its not a must. Ability to work productively with a broad and diverse group of stakeholders, Ability to prioritize task Education : Bachelor of Science (BS) degree with supply chain, CMC, clinical fields, pharma R&D, GMP certification is a must. Languages : English, Good to have written & spoken French proficiency but its not a Must. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

Job title : Sr. Mat. & Doc. Flow Manager Location: Hyderabad Work Mode : Hybrid About the job Our Team: The CMC (Chemistry, Manufacturing, and Controls) Demand and Supply Hub serves as the critical link between product development and market delivery, ensuring seamless coordination of supply chain activities to meet patient needs worldwide. We transform scientific innovation into reliable, high-quality pharmaceutical supply through strategic planning and operational excellence. Main responsibilities: The mission of the CMC Material & Documentation Flow Platform is to support the efficient coordination of Drug Product (DP) and Marketed Products (MP) transfer and receipt to sustain clinical and non-clinical development. Projects & scope: All products under the responsibility of the CMC Integrated Demand & Supply team Supports CMC Integrated Demand and Supply team in the management of material and documentation requirements for shipment and receipt of products (drug products or marketed products) under the accountability and supervision of / and the timelines defined by Demand & Supply Leader assigned to a given project. Providing Material Flow Management (MFM) services, Create and maintain material codes in ERP systems, Execute ERP transactions (Purchase Orders and Transfers Orders), Coordinate Drug product transfer from manufacturing facilities to packaging facilities Oversee Drug Product (DP) flow management for Contract Manufacturing Organization (CMO) Packaging, Coordinating and execute Drug Product destruction plans Serving as Subject Matter Expert (SME) for Qualipso and Provide technical support for Qualipso events management (including CMO/FSO) (e.g., temperature excursion management, deviation handling) Filling product documents such as (but not limited to): Product Information Document (PID), Drug Product Study Document (DPSD), Traceability reports, Technical Conditions for DP shipments, Filling products data in D&S tools such as (but not limited to) COMPASS, Demand Module (DMM), RDPM, Request of product documents to the appropriate owners as prerequisites for DP handling such as (but not limited to) TOR, quarantine and shipment authorization, CoR/CoA, US customs documentation, preparation and tracking of French Import License request form, Provide customs documentation expertise and support in documentation management in compliance with regulatory requirements: US customs documentation, CN customs requirements definition French Import License request form preparation and tracking Support operational planning activities by providing DP schedule information to CSC Operations warehouse About you 2-3 years of work experience in supply chain, CMC, clinical fields, pharma R&D, Good Knowledge of Global Exports and Imports is a plus. Good communication skills, Ability to work in a Global Team environment, Knowledge on Process Mapping and Continuous Improvement Strong knowledge of Pharma Product Manufacturing/Packaging, Strong knowledge of CMC and Clinical Supply Chain processes and deliverables Strong knowledge of ERP systems, Excellent oral and written communication skills Proficiency in written and spoken English is required to interact with multiple interfaces worldwide, Good to have spoken and written proficiency in French but its not a must. Ability to work productively with a broad and diverse group of stakeholders Ability to prioritize task Bachelor of Science (BS) degree with supply chain, CMC, clinical fields, pharma R&D , GMP certification is a must. Languages : English, Good to have written & spoken French proficiency but its not a Must. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

We re Hiring: Officer / Executive/ Sr Executive QA (Validation & CSV) Location: Gummidipoondi Injectable Plant Job Type: Full Time No. of Positions: 10 Education Qualification: B.Pharm / M.Pharm / B.Sc / M.Sc / B.E / B.Tech (Life Sciences / Pharma / Engineering streams) Experience: 2 to 6 years Preference for candidates with experience in sterile injectable validation and computer system validation (CSV) Key Responsibilities: 1.Prepare, review, and execute validation protocols, reports, and lifecycle documents. 2.Execute DQ, IQ, OQ, PQ for aseptic processing equipment including: Sterilizers (Autoclaves, Dry Heat Sterilizers) Depyrogenation tunnels Filling lines (vial, ampoule, prefilled syringe) Isolators / RABS (Restricted Access Barrier Systems) HVAC systems for cleanrooms LAF (Laminar Air Flow) units VHP (Vaporized Hydrogen Peroxide) systems 3.Familiarity with regulatory guidelines: 21 CFR Part 11, EU GMP Annex 1 4.Ensuring compliance with regulatory and quality standards If you re looking to grow your career in pharmaceutical validation and digital compliance, join our QA team driving quality and regulatory excellence. Apply for this position Allowed Type(s): .pdf, .doc, .docx By using this form you agree with the storage and handling of your data by this website. * About Us Caplin Steriles Limited, a subsidiary of fast growing pharmaceutical company Caplin Point Laboratories Ltd, specifically targeted towards regulated markets for Injectables and Ophthalmics.

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position You will be part of a highly motivated, collaborative, and diverse Computer Software Assurance / Validation Team. Job description: Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field Minimum 3+ years experience in IT & Software Validation (CSV/CSA, GAMP) Good knowledge of Food and Drug Administration regulations/guidance (i.e. CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices) Good understanding of system and data risk assessment General understanding of Agile Methodology(Framework (i.e. SAFe, Scrum), previous experience would be an advantage. Ability to work collaboratively in cross-functional and agile teams to achieve milestones and goals Effective communicator with excellent verbal and written communication skills - English language mandatory Assertiveness and ability to work with diverse personalities/cultures Let s find out what a usual day of work might look like. You will: Determine validation approaches, and identifies deliverables needed or impacted by a project / enhancement / change for GxP computerized systems Be responsible for the review of system documentation according to the Roche CSV SOPs and regulatory guidance Develop validation plans/reports, reviews test plans/reports (and other deliverables), and assess, authorize, and notify that the system is ready to go live Verify testing plans, activities, deliverables, and records, provide consultancy on test-related deviations and corrective actions according to approved procedures Support in deviation investigations to identify root causes and define corrective and/or preventative actions Support system audit/inspection preparation and execution as CSV subject matter expert Support system maintenance and enhancement activities, ensuring the validated state is kept, and it is audit and inspection ready Support system periodic reviews according to company procedure We offer: dedicated training budgets and many opportunities for personal and professional self-development (training, conferences, diversified career paths, etc.) a workplace that supports innovation and new ideas attractive benefits & business travel opportunities work in a great team with international colleagues on exciting topics to shape the IT behind the healthcare of tomorrow Who we are A healthier future drives us to innovate. Together, more than 100 000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let s build a healthier future, together. Roche is an Equal Opportunity Employer. "

• Manufacturing activities as per production plan for API / Intermediates • Production as per GMP & SOP • Review BMR Required Candidate profile • Ensure safety and other precautions during plant and RM handling • Ensure quality of products as per specification • Handling of manpower in shifts

Drive overall Operational excellence agenda while impacting key result areas around process efficiencies, smart and safe work place, standard operating procedures and best practice sharing Key Responsibilities Drive overall Operational excellence agenda while impacting key result areas around process efficiencies, smart and safe work place, standard operating procedures and best practice sharing Propagate data based reviews and action planning Detail orientation, prioritization and time management skills to ensure that work related activities are completed in an accurate and timely manner Work collaboratively with operations teams to prorogate process view , identify issues and root causes and facilitate innovative solutions Support adherence to standard operating procedures , compliance and audit requirements Establish an efficient/effective process for communicating activities, formally tracking/reporting status/results and sharing best practices across sites and client segments Assess current service delivery process baseline and identify process improvement opportunities Manage the process of selecting, scoping and prioritizing Lean/Kaizen projects including review of resource utilization within site service delivery operations Lead/support ongoing project reviews and reporting Qualifications: LEAN or Six Sigma Certified Assess current service delivery process baseline and identify process improvement opportunities Lead/support ongoing project reviews and reporting'

Job Title : Integration Specialist - LIMS Grade G11A Department/Group: Global IT/Projects Location: Baroda Job Summary Integration Specialist - LIMS, will be responsible for the integrating various lab instruments/software with LIMS application for successfully establishing paperless environment in QC/R&D Labs. This role requires a deep understanding of laboratory workflows, Instrument connectivity techniques, strong technical skills, and the ability to work closely with cross-functional teams to ensure the LIMS meets the needs of the organization Job Description Role and Responsibilities Support in QC/R&D lab instrument integration with LIMS application, at the time of LIMS implementation at various locations of SUN Pharma. Develop and execute test scripts, and relevant documentations required as part of validation activity. Configure LIMS software to meet the specific needs during Instrument integration activity. Provide training and support to end-users, ensuring they are proficient in using the LIMS. Troubleshoot and resolve any issues related to LIMS performance, functionality, and integration with other systems/instruments. Maintain comprehensive documentation of the LIMS implementation process, including user guides and technical manuals. Shall be aware about documentation of LIMS application as per GMP. Shall be able to create and manage documentation of LIMS application to ensure system is in compliance state. Qualifications and Preference Qualifications Bachelors degree in Information Technology, or Computer Science or related field. Minimum of 4-5 years of experience in LIMS implementation & Instrument Integration activity, preferably in a pharmaceutical or biotech environment. Strong understanding of laboratory processes and workflows. Deep understanding of Lab Software functionality such as Empower, LabSolutions, Chromeleon. Strong command on Data extraction / connectivity methodologies techniques for port based instruments such as balances, pH etc. Proficiency in LIMS software (Expertise on CaliberLIMS is preferred) Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Experience with regulatory compliance requirements (e. g. , FDA, GMP, GLP). Preferred Qualifications Advanced degree in Life Sciences, Information Technology, or a related field. Familiarity with laboratory instruments and their integration with LIMS Experience with Caliber LIMS is preferred. Good documentation skills to create and manage GxP documents.

At Elanco (NYSE: ELAN) it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We re driven by our vision of Food and Companionship Enriching Life and our approach to sustainability the Elanco Healthy Purpose to advance the health of animals, people, the planet and our enterprise. Making animals lives better makes life better join our team today! Your Role: R&D Project Management -Group Lead This role is responsible for leading and overseeing project managers based in the APAC region of the Global R&D Strategic Project Management Organization (SPMO) and utilizing key project management processes and tools to partner with project teams to deliver an asset and portfolio value with quality on time, on budget and within scope. This role will implement sound project management processes within teams for the projects they are accountable for and hold direct reports accountable to consistent business process appropriately. The individual in this role will utilize project management standards, processes and tools to evolve the R&D SPMO to the next level. The individual in this role is expected to exhibit key leadership behaviors which enable innovative solutions, a positive and motivating work environment, ultimately accelerating Best in Innovation. Leadership Responsibilities: Lead, develop and coach project managers in the R&D SPMO to ensure continuous development and learning of the team. Accountable for the performance of the team; including respective prioritization, resource planning, performance management, development, and training. Create a psychologically safe, resilient and engaging work environment that is aligned with company vision, promises, values and behaviors. Responsible for uniformity and alignment of project plans across R&D and ensure the accountability of project managers to these quality standards and expectations of timely delivery. Ensure project managers are accountable for maintaining visibility and momentum of critical path milestones, surfacing issues and barriers, facilitating productive resolution and providing clear communication to Project Leaders. Ensures project managers are actively managing and communicating project OPEX with teams to drive towards financial targets with high accuracy. Thorough understanding of R&D development process to enable teams to develop robust project strategies that identify and proactively mitigate project risks and constraints Recognized as a project management expert with a strong foundation in global drug development processes (with a preference in animal health) Enables the business by applying lean six sigma tools and project management skills to drive non-pipeline projects that are critical to the success of our business. Responsible for the data completeness, quality and accuracy within business systems Utilizes external inputs and ideas, leveraging business process knowledge to drive transformation within the function and cross-functionally Identify areas of improvement in the R&D SPMO and take initiative to develop solutions where needed. Identifies and shares learning opportunities and process improvements with the team to streamline the effectiveness/efficiency of conducting drug development programs and ultimately, identify methods to decrease development cycle times. Lead process improvement initiatives to evolve and encourage continuous improvement in the SPMO. Be a change agent. Project Management Responsibilities: Managing project progression strategy (timeline, budget, risks, mitigation plans, etc. ) to facilitate delivery of Elanco pipeline assets in partnership with project leaders and project team. Management of the project team budget using tools such as SAP , Ariba , MS Excel, R&D Procurement tool and cooperation with Procurement and the Operations & Information Management Team Tracking and reporting of project team OPEX to ensure reliable delivery to finance target and provide forecasting and actual spend reports for projects In coordination with the Project Leaders, drive execution of global project deliverables for projects by controlling project schedule/ timeline, cost, and performance risks using MS Project, Project Online, Project Management principles, and risk management tools Provide operational oversight for projects from initiation through close, while ensuring deliverables are met on schedule and within budget constraints Facilitate regular project status meetings with team members and key stakeholders and take minutes, document decisions, and actions Proactively communicate project status, issues and risks to project stakeholders and escalate issues when appropriate Manage the tracking and reporting of key project success measures for scorecards as well as project metrics to support business planning cycles and strategic initiatives Basic Qualifications: Masters degree in scientific field or BS with equivalent experience PMP certification with 2 3 years experience or 5-7 years Project management experience. Experience in project management methodologies (PMP, Agile, etc. ) Experience with project management tools such as Project Online, Risky Project, MS Project, Power BI Strong understanding of research and development and regulatory needs for animal health industry Strong experience working with GCP/ GLP/ GMP and quality principles Experience managing, leading and developing people Demonstrated ability to work effectively and influence cross-functional teams Demonstrated ability to work and influence external partners Demonstrated ability to lead and develop a team Ability to multi-task and work on several initiatives at the same time Proven to be an agile learner Preferred Qualifications: Master of Business Administration (MBA) Basic knowledge of IT tools, agile learner of new IT tools/ systems Strong learning agility Six Sigma Green Belt (or above) Experience leading teams remotely Basic training and understanding in business acumen and business case foundations Additional Information: Travel: [insert on an annual percentage basis] Location: IN, Bangalore - Hybrid Work Environment Don t meet every single requirementStudies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but dont necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles! Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

Job Classification Code Job Classification Label Job Title: Manager, MES & L2 project coordinator Job Grade (refer to JE) G10 Function: Global IT Sub-function: Manufacturing IT Manager s Job Label: Skip Level Manager s Label: Function Head Title: Location: Halol/Baska No. of Direct Reports (if any) 0 Business Unit: Job Summary We are seeking a seasoned professional with 7-9 years of experience in the pharmaceutical industry, including hands-on expertise in Manufacturing Execution Systems (MES) and L2 integration. The Site Project coordinator for MES Implementation will be the primary coordinator for all MES-related activities at the Halol / Baska sites. This role demands dedicated full-time support to the project to ensures smooth execution, alignment with the global MES strategy, and timely delivery of milestones to enhance manufacturing efficiency, compliance, and digital transformation. The role will work closely with internal teams including QA, IT, SAP, business users, and L2 integration as well as external vendors and infrastructure leads. Responsibilities include stakeholder management, managing project timelines, risks, and dependencies, ensuring infrastructure readiness, facilitating change management, and maintaining compliance with site validation and quality standards. As the single point of contact for MES implementation at the site, the site coordinator plays a critical role in driving collaboration and successful deployment. The ideal candidate will ensure adherence to global regulations (FDA 21 CFR Part 11, EU GMP, GAMP5) Previous experience with Werum (Korber Pharma) for pharma industry is a big plus Areas Of Responsibility Project Coordination: Lead and coordinate all MES implementation activities at the site, ensuring alignment with the global MES strategy. Stakeholder Management: Serve as the single point of contact for site-level stakeholders, including QA, QA IT, IT, SAP, and business users (Production & Engineering) Vendor & Partner Collaboration: Work closely with MES vendors, infrastructure teams, and integration partners to ensure smooth execution. Timeline & Risk Management: Manage project schedules, track milestones, identify risks, and implement mitigation plans. Infrastructure & Readiness: Ensure site infrastructure (network, servers, systems) is ready and validated for MES deployment. Compliance & Validation: Oversee adherence to site quality standards, IT validation (CSV), and regulatory requirements. Communication & Reporting: Maintain clear and timely communication with the Global Project Manager and other stakeholders; provide regular updates and escalate issues as needed. Change Management: Facilitate change control processes and support user readiness and adoption. Travel Estimate Less Job Scope Internal Interactions (within the organization) Global Project Manager - MES Program Site QA and QA IT teams Site IT and Infrastructure teams Production, Operations teams SAP Coordinators Site SME and Global SME External Interactions (outside the organization) MES vendors and implementation partners System integrators (L2/PLC/SCADA) Infrastructure service providers (network/server) Validation consultants (if outsourced) Auditors (during validation or compliance reviews) Geographical Scope Halol/Baska site Financial Accountability (cost/revenue with exclusive authority) No direct financial authority Job Requirements Educational Qualification Bachelor s degree in Engineering, Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field. Preferred: Master s degree (e. g. , MBA, M. Tech, M. Pharm) with specialization in Project Management, Operations Management, Industrial Automation, or Pharmaceutical Technology. Specific Certification PMP - for structured project execution (Preferred) GAMP5 or CSV Training - for compliance in regulated environments Experience 7-9 years of experience managing IT or digital transformation projects, preferably in pharmaceutical manufacturing. Hands-on experience with MES platforms, L2/PLC systems, and SAP integration and Edge Cloud IoT. Proven track record in project planning, stakeholder coordination, and cross-functional team leadership. Strong background in GxP compliance, CSV, and validation protocols (IQ/OQ/PQ). Experience working on the shop floor and with QA, IT, and business teams in a regulated environment. Skill (Functional & Behavioural): Functional: Strong project management expertise in IT/digital systems, Knowledge of MES platforms, L2/PLC systems, and SAP integration, Familiarity with GxP, CSV, and validation protocols (IQ/OQ/PQ), Understanding of pharmaceutical manufacturing processes and shop floor operations, Proficiency in stakeholder coordination and cross-functional collaboration Behavioral: Strong communication and interpersonal skills, Proactive problem-solving and risk management, High attention to detail and compliance mindset, Ability to work under pressure and manage multiple priorities, Team-oriented with a focus on collaboration and accountability Additional Skills: (Good to have) Knowledge of data analytics tools Edge Cloud deployment experience with (IoT and and IIoT) L2 integration with MES MES integration with SAP Understanding of network and databases Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

Job Title: sLIMS Implementation Support Job Category: Permanent Department/Group: Global IT/Projects Job Code/ Req#: NA Location: Baroda Travel Required: Yes Level/Salary Range: G10 and below Position Type: FTE Contact: NA Date Posted: June-25 Will Train Applicant(s): NA Posting Expires: NA External Posting URL: NA Internal Posting URL: NA Job Summary sLIMS Implementation Specialist will be responsible for the successful deployment, configuration, and ongoing support of our Laboratory Information Management System (SLIMS). This role requires a deep understanding of laboratory workflows, strong technical skills, and the ability to work closely with cross-functional teams to ensure the SLIMS meets the needs of the organization Job Description Role and Responsibilities Support in implementation and configuration of the sLIMS, ensuring alignment with laboratory workflows and regulatory requirements. Execute the tasks defined in project plans, adhering to timelines, for successful implementation of sLIMS. Configure sLIMS software to meet the specific needs of the laboratory, configuring workflows, and setting up user roles and permissions. Provide training and support to end-users, ensuring they are proficient in using the sLIMS. Troubleshoot and resolve any issues related to sLIMS performance, functionality, and integration with other systems/instruments. Maintain comprehensive documentation of the sLIMS implementation process, including user guides and technical manuals. Shall be aware about documentation of sLIMS application as per GMP. Shall be able to create and manage documentation of sLIMS application to ensure system is in compliance state. Qualifications and Preference Qualifications Bachelors degree in Information Technology, or Computer Science or related field. Minimum of 4-5 years of experience in sLIMS implementation, preferably in a pharmaceutical or biotech environment. Strong understanding of laboratory processes and workflows. Proficiency in sLIMS software (Expertise on CaliberLIMS is preferred) Ability to manage multiple tasks simultaneously. Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Experience with regulatory compliance requirements (e. g. , FDA, GMP, GLP). Preferred Qualifications Advanced degree in Life Sciences, Information Technology, or a related field. Familiarity with laboratory instruments and their integration with SLIMS Experience with Caliber LIMS is preferred. Good documentation skills to create and manage GxP documents. Reviewed By: Date: Approved By: Date: Last Updated By: Date/Time:

Job Title : Testing and Documentation Support Grade G11A Department/Group: Global IT/Projects Location: Baroda Job Summary LIMS Testing & Documentation Specialist will be responsible for the thorough testing of LIMS application before deployment or patch deployment. This role requires a deep understanding of laboratory workflows, strong technical & testing skills, and the ability to work closely with cross-functional teams to ensure the LIMS meets the needs of the organization Job Description Role and Responsibilities Support testing of LIMS functionalities to ensure the functionality available, is working as per users expectation as well as it meets the approved user requirement specification. Develop testing strategy and execute it to meet the implementation timelines. Perform the impact assessment of newly added functions on the existing functionalities. Rigorously test the newly introduced functionalities based on its impact on the existing functionalities. Provide training and support to end-users, ensuring they are proficient in using the LIMS. Troubleshoot and resolve any issues related to LIMS performance, functionality, and integration with other systems/instruments. Maintain comprehensive documentation of the LIMS implementation process, including user guides and technical manuals. Shall be aware about documentation of LIMS application as per GMP. Shall be able to create and manage documentation of LIMS application to ensure system is in compliance state. Qualifications and Preference Qualifications Bachelors degree in Information Technology, or Computer Science or related field. Minimum of 4-5 years of experience in LIMS implementation, preferably in a pharmaceutical or biotech environment. Strong understanding of laboratory processes and workflows. Proficiency in LIMS software (Expertise on CaliberLIMS is preferred) Excellent testing skills, with the ability to manage multiple tasks and projects simultaneously. Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Experience with regulatory compliance requirements (e. g. , FDA, GMP, GLP). Preferred Qualifications Advanced degree in Life Sciences, Information Technology, or a related field. Familiarity with laboratory instruments and their integration with LIMS Experience with Caliber LIMS is preferred. Good documentation skills to create and manage GxP documents.

Roles and Responsibilities Maintain accurate records of all quality-related activities and reports. Conduct quality audits, internal audits, BMR review, capa, change control, GMP compliance, deviation management. Ensure adherence to cGMP guidelines during production runs. Identify areas for improvement through continuous monitoring of processes and implement corrective actions. Collaborate with cross-functional teams to resolve quality issues and improve overall productivity. Document issuance (i.e., Batch Manufacturing Record , Lab Note Book, Log books, analytical work sheets, SOP formats etc.,) Review of executed documents (e.g., Batch Manufacturing Record, analytical work sheets Equipments usage log books, area cleaning records, calibration records, preventive maintenance records, Lab Note Book,) Retrieval and archival of quality management system related documents. Preparation of annual schedules (GMP training schedule and On Job Trainings, Preventive Maintenance, Equipment calibration, Internal Audit and Management Review Meeting) and conducting according to these schedules. Initiate the change control, deviation related to quality functions. Preparation of Certificate of analysis Coordinating with External Testing Laboratories. Reviewing the completed analytical reports, Calibration reports for its compliance. Reviewing the Instrument/Equipment master Calibration schedules for its compliance. Assistance for the new analytical method development and validation as per the guidelines.

Job description BMS Validation Project - Execution SCADA Validation Project - Execution PLC System Validation Project - Execution To Handle the site engineers as per the project given by Head / Senior To prepare the work reports related to projects

COMPUTER OPERTOR WITH FULLY KNOWLEDGE OF TALLY MAKING ENQUIRY , QUOTATION, INVOICE Operate and monitor computer systems and equipment. Perform routine maintenance and troubleshooting of computer hardware and software. Ensure the security and integrity of data and systems. Collaborate with IT staff to resolve technical issues. Maintain accurate records of computer operations and activities. Provide technical support and assistance to users. Stay updated with the latest advancements in computer technology.

Role Overview Responsible for qualification & calibration activities for defined instruments and equipment as per schedule & procedures with QMS. Illustrative Responsibilities Ensure that qualification & calibration activities are planned and executed within time frame defined by the procedure and equipments are released on time as per the pre-defined schedule. Responsible for coordinating with lab supervisors / system owners for handling of any non-conformances or escalations Handling of QMS related activities like, Change control, CAPA and Deviation with its effectiveness check. Responsible for quality compliance activities for laboratory instruments qualification and calibration. Summarize, review, and report the analytical Instruments qualification and calibration for further approval. Ensure a disciplined work environment to provide expertise to subordinates colleagues in the proper performance of laboratory procedures. Ensure on time GDP in technical function with right first time (RFT) approach. Responsible for ensuring team compliance to EHS, Quality & Business policies Any other work given by management from time to time. Quality & Compliance Responsible for following GMP/GLP/ GDP/EHS policies by self as well as the team Required skills Technical expertise in Analytical instruments qualification, calibration, protocol preparation and QMS. Build cohesive team valuing team spirit Able to anticipate the implications and consequences of situations and take appropriate actions in the interest of Client as well as Cal Scientific without compromising quality. Clear thoughts and effective and crisp communication. Job requirement M.Sc specializing in Chemistry/ M. Pharma with proven experience of min. 8-10 yrs. in Instrument qualification and calibration. In depth experience in Chromatography (HPLC, UPLC, GC), Spectroscopy (MS, FTIR, UV), Thermal techniques (DSC, TGA) and Particle size measurements. Expertise in analytical instruments qualification and calibration, protocol preparation, CAPA, Investigations, Deviations (QMS) Good Knowledge of ICH guidelines and different global regulatory authorities. Job Location-Mulund

As a Senior Executive - Chemistry in the Quality Control department at Zydus Pfizer located in Ahmedabad, your role will require you to have a Bachelor's degree in Pharmacy or a Master's degree in Chemistry along with 2 to 4 years of relevant experience. Additionally, experience within Zydus for a minimum of 12 to 24 months is preferred. Your responsibilities will include hands-on experience with GMP/GLP/GDP/Data integrity ALCOA+ practices and the operation and calibration of various Wet chemistry techniques such as IR, UV, pH, KF, Polarimeter, and LPC. You will also be expected to handle operations, sample analysis, method validation, calibration, and troubleshooting of HPLC systems from Agilent and Shimadzu. Proficiency in basic computer applications like Word, Excel, and PowerPoint is essential for this role. In terms of behavioral skills, you should be self-motivated with basic problem-solving abilities. Your administrative skills should encompass being proactive, effective time management, and a collaborative approach towards working with team members. Excellent communication skills, both written and verbal, are crucial for this position to ensure seamless coordination within the team and across departments.,