302 Cgmp Jobs

Job description Description: Strict adherence to cGMP, Statutory norms and safety rules of the factory Taking a role of competent person under the Engg. Sr.Manager and reporting back the progress / Issues on daily basis. Prepare the list of equipment's and update the same whenever require in line with the QA Prepare the annual PM, Validation and qualification schedule of equipment's, ensure the effective implementation in line with SOP Upkeep the plant and equipment's to ensure any time audit readiness. Engage the team members in a productive manner. Manage the contract workers effectively and verify their measurements, billings with actual work done. Access the critical spares for the equipment's and ensure its availability on time. Collaborate with the cross functional teams to build consensus. Take a lead to prepare / update the documents for the ISO audits. Prepare the monthly global engineering reports. Understand the global engineering standards, identify and explore the gaps, ensure the training to all employees in the department for the approved standards. Understand the system, Operation and Procedures identify the opportunities in terms of Energy conservation, overcome the repeated jobs, reduce frequent breakdowns in line with the overall operational excellence.

Job description Provide technical leadership and administrative control for supply of uninterrupted utility services. Maintain best practices to ensure compliance of cGMP Developing systems and processes for high performance delivery. Maximizing capacity and proper resources utilization. Comply with various regulatory requirements pertaining to engineering activities. Identify area of energy conservation and take operational and technological measures for efficient utilization of energy. To Supervise shift operation in plant maintenance. To execute Preventive maintenance plans of respective area, and complete related documentation as required by SOP. Identifying repeated breakdown and report and plan for corrective action along with engineering manager to avoid recurrence. To participate in qualification requalification of plant machine/equipment and functional support for calibration activity To follow Good documentation practices and ensure compliance by workmen Impart on job training to the workmen for SOP and related functions. Compliance to Quality, safety and Regulatory requirements.

Job description Provide technical leadership and administrative control for supply of uninterrupted utility services. Maintain best practices to ensure compliance of cGMP Developing systems and processes for high performance delivery. Maximizing capacity and proper resources utilization. Comply with various regulatory requirements pertaining to engineering activities. Identify area of energy conservation and take operational and technological measures for efficient utilization of energy. To Supervise shift operation in plant maintenance. To execute Preventive maintenance plans of respective area, and complete related documentation as required by SOP. Identifying repeated breakdown and report and plan for corrective action along with engineering manager to avoid recurrence. To participate in qualification requalification of plant machine/equipment and functional support for calibration activity To follow Good documentation practices and ensure compliance by workmen Impart on job training to the workmen for SOP and related functions. Compliance to Quality, safety and Regulatory requirements.

You will be responsible for vaccine manufacturing activities related to cell culture, including cell revival, subculture, and cell counting of MRC-5 cells. Your role will involve the preparation of Master Cell Banks (MCB) and Working Cell Banks (WCB). You should have experience in handling Roller bottles, Cell stacks, and Tissue Culture Flasks (TCFs). Additionally, you will be required to prepare media and in-process buffers in media mixing vessels. Moreover, your duties will include experience in virus infection and virus harvesting procedures. You should be familiar with working on Chicken embryo fibroblast cells, involving tasks such as pooling embryos and seeding Roller bottles. In the Quality Control department, you will be expected to perform various biochemical techniques, chromatography techniques, electrophoresis techniques, and immunoassay techniques. Your expertise should also cover cell culture techniques and molecular techniques. Furthermore, you will be involved in activities such as Analytical Method Validation (AMV), Analytical Method Development and Transfer, Quality Control (QC) procedures, and ensuring compliance with cGMP, cGLP, and Quality Management System (QMS) standards.,

You are looking for a QC Chemist with 4-5 years of experience or a Fresher in quality control lab. The ideal candidate should be familiar with operating sophisticated instruments such as HPLC, GC, and SPECTOPHOTOMETER. It is essential that the candidate has received training in cGMP. Salary is negotiable based on the candidate's experience. If you are interested in this position, please apply with your resume to the provided email address. This is a full-time, permanent role with benefits including Provident Fund. The preferred education level for this position is a Bachelor's degree. The preferred total work experience required is 2 years. The work location for this position is in person.,

As a Production Manager, you will be responsible for overseeing and managing day-to-day production operations to meet quality, cost, and delivery targets. You will develop and implement production schedules to ensure timely product delivery while ensuring adherence to Good Manufacturing Practices (GMP) and compliance with USFDA regulations. Your role will involve maintaining and ensuring compliance with USFDA, WHO, and other regulatory standards in all production processes. You will coordinate with the Quality Assurance (QA) team to prepare for and manage regulatory audits, inspections, and proper documentation of manufacturing processes. Leading, mentoring, and training the production team will be essential to ensure optimal performance and awareness of regulatory requirements. You will foster a culture of continuous improvement, accountability, and teamwork among the team members. Identifying and implementing process optimizations to improve productivity, efficiency, and quality will be part of your responsibilities. Collaboration with cross-functional teams such as R&D, Quality Control (QC), and Supply Chain to resolve production-related issues is crucial. Additionally, you will be accountable for maintaining and calibrating production equipment and facilities, implementing safety protocols, managing inventory of raw materials, and preparing and managing the production budget to optimize costs without compromising quality. To qualify for this role, you should hold a Bachelors or Masters degree in Pharmacy, Pharmaceutical Sciences, Biotechnology, or a related field. A minimum of 5-7 years of experience in pharmaceutical manufacturing in a managerial role is required, along with proven experience in a USFDA-regulated environment. Knowledge of cGMP, CAPA, and regulatory submissions is essential. Your technical and functional skills should include a strong understanding of pharmaceutical production processes, familiarity with validation protocols, exceptional leadership, communication, and interpersonal skills, strong analytical and problem-solving abilities, and the ability to work under pressure and meet tight deadlines.,

You will be responsible for conducting site surveys and plotting layouts based on drawings. Additionally, you will interpret plans and specifications, monitor architectural, structural, and finishing work to ensure compliance with drawings. You will oversee work progress, quality, and adherence to building codes and regulations. It will be your duty to prepare and monitor schedules, ensuring timely project completion. You will manage contractors, review bills as per tender BOQ, and coordinate with seniors, contractors, and other professionals to achieve project objectives. Daily progress reports must be prepared and sent, and cross-functional teams will be collaborated with for timely project delivery. As part of your responsibilities, you will monitor the quality of work in accordance with IS standards, inspect materials, and assess work quality for contract compliance. On-site testing of materials as per ITP and QAP will also fall under your purview. You should have knowledge of safety practices, permits, and norms, as well as proficiency in AutoCAD, civil estimation, MS Project/Primavera, and QA/QC protocols. Understanding of cleanroom panels, cGMP practices, and various finishes in the pharma industry is essential. Key Skills: - Site layout, BOQ review, and drawing interpretation - Monitoring civil, structural, and finishing works - Schedule tracking, contractor management, and billing - QA/QC checks, material inspection, and testing (ITP/QAP) - Knowledge of cleanroom panels, pharma finishes, and cGMP - Familiarity with IS codes, safety norms, and permit systems - Proficiency in AutoCAD, MS Project/Primavera, and estimation - Strong coordination, reporting, and problem-solving skills Qualifications: - Diploma/Bachelors in Civil Engineering or related field - 6-10 years of site execution experience (preferably in the pharma/industrial sector) - Knowledge of QA/QC protocols and regulatory compliance - Strong communication and documentation abilities,

As a maintenance engineer, your primary responsibilities will include maintaining facility and equipment, procuring engineering consumables and proprietary spares, and managing inventory. You will be responsible for performing and approving qualification studies for equipment and facilities, as well as scheduling and executing preventive maintenance programs for plant and utility equipment. Additionally, you will review and participate in process validation programs, update technical drawings such as plant layout and P & ID, and manage annual maintenance programs for utility and material handling equipment. You will also be involved in arranging instruments for plant equipment, ensuring compliance with quality documents, and meeting statutory requirements related to boiler/electrical inspections and standard weights. Your role will also involve executing plant modifications as per approved capex and plant requirements, maintaining cGMP and EHS compliance, and organizing training for department employees on SOPs, new systems, and qualifications. You will review maintenance reports and energy consumption data to identify areas for improvement and take corrective actions as necessary, in addition to overseeing the annual engineering budget. Overall, you will play a crucial role in ensuring the smooth operation and maintenance of plant equipment and facilities, while upholding high standards of quality, compliance, and safety.,

The In-Process Quality Assurance Executive plays a crucial role in ensuring that all products adhere to cGMP and regulatory standards throughout the manufacturing and packaging processes. You will collaborate closely with production teams to uphold product quality and address any issues that arise in real-time. Your responsibilities will include overseeing the quality of products from the warehouse to production and packing stages, ensuring compliance with cGMP and regulatory requirements, identifying and resolving quality issues promptly, and participating in investigations of deviations and non-conformances. You will also be responsible for maintaining detailed documentation of quality-related activities, participating in audits and inspections, offering guidance and training to production personnel, and contributing to the development and review of quality procedures and policies. To excel in this role, you should hold a Bachelor's degree in Chemistry, Biochemistry, Pharmacy, or a related field, along with a minimum of 1 year of experience in in-process quality assurance within the pharmaceutical industry. Proficiency in cGMP and other regulatory standards, excellent problem-solving and communication skills, the ability to work both independently and collaboratively, and experience in audits, inspections, and root cause analysis are essential. Staying informed about the latest regulatory requirements and industry best practices is also crucial for success in this position.,

You will be responsible for Vaccine Manufacturing (Cell Culture), including tasks such as cell revival, subculture, and cell counting of MRC-5 cells. You will also be involved in the preparation of MCB/WCB and handling Roller bottles, Cell stacks, and TCFs. Experience in virus infection, virus harvesting procedures, and working with Chicken embryo fibroblast cells will be required. In the Quality Control department, you will be expected to perform various biochemical techniques, chromatography techniques, electrophoresis techniques, and immunoassay techniques. Your responsibilities will also include cell culture techniques, molecular techniques, analytical method validation (AMV), and analytical method development and transfer quality control (QC). Knowledge of cGMP, cGLP, and QMS will be essential for this role.,

Trending Job Description To execute analysis of finished goods / Stability samples / Raw materials / Packing materials In-process and cleaning samples along with relevant laboratory documentation. Intimation & result reporting after completion of analysis & relevant documentation. Check all the instruments on the equipment required for the analysis are in working condition and are in calibrated state. Checking and ensuring proper status labels after confirming availability of all the requirements (as applicable) for analysis such as approved control procedure, analytical protocol, reference standards, chemicals, reagents, glassware, water preparation equipment, water bath, sonication baths, mobile phase bottle etc. Ensure the online documents pertaining to day-to-day analysis are efficiently completed in timely manner. Reporting the activities daily to immediate supervisor. Destruction of QC Samples like Retention samples, analyzed samples etc. To take out the quality reports, Data / Results entry in SAP system. To prepare and maintain the working standards & documentation. Ensure timely raising and closure of deviations, quality events, change controls, OOS/OOT. Preparation and maintenance of Analytical data sheets and Excel spread sheets. Adequate knowledge of all equipment/instruments & their functioning in the laboratory & assist in equipment/instrument qualification activities. Ensuring the quality and integrity of all GxP data and documentation generated. Ensuring effective execution requirements of food regulations (US)-21 CFR Part 111. Ensure fully Engagement and Involvement regarding awareness, clarity maintained related to data integrity. Ensure the 21 CFR Part 11 compliance in the Laboratory. Ensuring good housekeeping and accident-free working in the Laboratory. To perform safe Laboratory operations (as per MSDS) ensuring proper usage of PPEs, safe, secure storage of hazardous, toxic, explosive, corrosive, irritant materials. Ensure proper maintenance of HPLC and GC column and related logbooks in QC lab. To fulfill the analytical requirements of FSSAI regulation. To undergo assigned trainings on cGMP, HSE & departmental procedures / policies. To determine internal and external QEHS issues as well as needs and expectations of relevant interested parties and monitor the same.To implement QEHS policy & objectives. To ensure participation and consultation of worker. To identify & communicate incidents, QEHS non conformities, investigate and take corrective actions on the same. To ensure work permit system during maintenance activities. To ensure disposal of waste. Qualifications QC Analyst (Apprentice) Qualification: M.Sc. Chemistry About Us In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices. Equal employment opportunity Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics. We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice. About The Team Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limiteds investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide. Job Info Job Identification 9087 Job Category Quality Control Posting Date 07/29/2025, 08:05 AM Job Schedule Full time Locations Piramal Enterprises Limited, Plot no. K-1, Mahad, Maharashtra, 402302, IN Show more Show less

You will be responsible for strictly following cGMP, Safety and Environmental Practices, as well as ensuring Good Manufacturing practices during operation. This includes filling Batch Manufacturing records and equipment cleaning records, maintaining proper personnel protective equipment usage, and ensuring good housekeeping in the respective plant area and its equipment. You will need to plan and ensure raw material availability for daily production as per the production plan, maintain documents like Issue and dispensing register, and carry out processes as per Batch Manufacturing Records (BMR) without any deviation. It is essential to adhere to data integrity in online documentation and handle hazardous operations in a safe manner. Additionally, you will be expected to effectively utilize resources such as utility, men, and machines. Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) that offers end-to-end development and manufacturing solutions across the drug life cycle. PPS serves customers globally through a network of facilities in North America, Europe, and Asia. The services provided include drug discovery solutions, process and pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. Specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products and services, and potent solid oral drug products are also offered. PPS caters to the development and manufacturing of biologics such as vaccines, gene therapies, and monoclonal antibodies. With experience across varied technologies, PPS has established itself as a trusted service provider and a preferred partner for innovators and generic companies worldwide.,

As a member of ACG Capsules in Shirwal, your primary responsibilities include checking the allocated post production line(s) such as ATS/Printing/camera in each shift according to the CTQ (critical to Quality) / CTP (Critical to Productivity) checklist. You will need to adhere to the plan outlined in the color change note, minimizing change over time at each sub-section. Following instructions from the shift lead is crucial for timely changeover, ensuring the availability of necessary equipment like roller(s) and ink. Furthermore, it is essential to execute In-Process Quality Control (IPQC) after each roller cleaning, checking camera rejections hourly to achieve zero defects. Operating the camera according to Standard Operating Procedures (SOP) is vital to maintain productivity and quality standards. Collaboration with contract associates is necessary to ensure SOP compliance at ATS, Camera, Packing, Sealing, and Tumbling sections. You will be responsible for implementing preventive maintenance plans for the line(s) to minimize downtime and conducting troubleshooting activities to enhance productivity. Reporting and controlling post-production losses of printing and camera operations are crucial for achieving the Targeted AFOE@Despatch. Adhering to cGMP and GDP for the allocated line(s) is essential to comply with regulatory standards during the shift. Additionally, following instructions from the shift lead or team lead to implement Corrective and Preventive Actions (CAPA) for any customer complaints is part of your duties. Key Result Areas for this role include ensuring productivity of the line, managing print loss, print reject, and camera loss, prioritizing safety measures, and adhering to Standard Operating Procedures (SOP). In this role, you will interface with ITI candidates, as well as freshers. The competencies required for this position include [Competencies to be filled based on the job description provided].,

You will be responsible for performing testing on in-process material, bulk drug substance, finished drug product, and stability samples in a cGMP laboratory setting. Your role will involve ensuring compliance with cGMP and FDA requirements. The position reports to the QC lab Supervisor. The ideal candidate should have 2 to 6 years of experience in a cGMP laboratory environment and be familiar with cGMP and FDA requirements.,

You will be joining our team as a Deputy Manager/Manager, Analytical method transfer, responsible for delivering developed analytical assays from R&D scale to GMP-compliant commercial quality control labs. Your role will involve overseeing projects related to analytical method transfer, collaborating with cross-functional teams, and ensuring technology transfer and assays qualification activities are conducted in compliance with GLP and GMP standards. The ideal candidate will possess expertise in cGMP, regulatory requirements, technical troubleshooting, method transfer, method validation, technology transfer, and laboratory techniques to support routine testing and release of research and cGMP grade materials. You will be directly involved in drafting technology transfer documents, risk assessments, process FMEA, method validation protocols, facility fit assessments, and other related activities necessary for the release and testing of microbial and mammalian fermentation-based products. You should have familiarity with analytical assays such as HPLC, GC, SDS-PAGE, agarose gel electrophoresis, densitometry, dd-PCR, RT-PCR, ELISA, UV-Visible spectrophotometry, western-Blot, as well as microbiological techniques like BET, BioBioburdend Sterility testing. Additionally, the position may entail assisting in cell bank testing and release under cGMP regulations and coordinating with third-party collaborators for external testing as needed. Your responsibilities will also include authoring and reviewing research studies, compiling experimental data, and contributing to protocols, study reports, and publications with minimal supervision. You will work as part of the method transfer and method validation team, ensuring timely and successful completion of process transfers while addressing any unexpected technical challenges. We are looking for individuals who are enthusiastic, highly motivated, and capable of multitasking. The role requires working collaboratively within a team environment and independently across various aspects of projects related to microbial-derived products.,

Experience Required: You must have a strong background in contract manufacturing. Demonstrated experience in managing Greenfield and Brownfield projects is highly desirable. Primary Coordination And Execution: You will collaborate closely with cross-functional teams to ensure timely project delivery. It will be your responsibility to design and layout facilities for Greenfield and Brownfield projects, considering operational requirements and constraints. Additionally, you will be required to prepare detailed manufacturing documentation for new facilities and third-party (3P) manufacturing units. Supplier And Partner Management: You will oversee and streamline the operations of existing contract/3P manufacturing units. Identifying, onboarding, and operationalizing new contract/3P manufacturing partners will be part of your role. It is also crucial to resolve partner-related issues while maintaining strong, compliant relationships with suppliers. Leading contract negotiations with inputs from legal and other key stakeholders will be a key responsibility. Regular site visits to assess readiness for product launches and new product development activities will also be required. Process Optimization And Implementation: You will evaluate workflows to identify inefficiencies and implement best practices in both existing and new manufacturing setups. Facilitating product and process approvals, permits, and licenses in collaboration with project, quality, and regulatory teams is essential. Ensuring adherence to CGMP and safety protocols across all plant operations is a critical aspect of the role. Furthermore, you will need to incorporate cutting-edge practices into equipment selection, process design, and facility layout to ensure optimal performance. Cost Management: Identifying opportunities for cost optimization across contract/3P manufacturing units will be a key focus. Implementing continuous improvement strategies to achieve sustainable cost savings in operations is a crucial part of the role.,

As a member of our team at Piramal Pharma Solutions (PPS), you will be responsible for ensuring strict adherence to cGMP, Statutory norms, and safety rules of the factory, taking on the role of a competent person under the Engineering Sr. Manager. Your key responsibilities will include reporting progress and issues on a daily basis, preparing and updating the list of equipment in line with Quality Assurance (QA) requirements, and creating the annual Preventive Maintenance (PM), Validation, and Qualification schedule for equipment. You will be expected to maintain the plant and equipment to ensure audit readiness at all times, engage team members productively, effectively manage contract workers, and verify their measurements and billings. Additionally, you will need to access critical spares for equipment and ensure their availability, collaborate with cross-functional teams to build consensus, and lead the preparation and updating of documents for ISO audits. Your role will also involve preparing monthly global engineering reports, understanding global engineering standards, identifying and addressing gaps, and providing training to all department employees on approved standards. Understanding the system, operation, and procedures, you will be tasked with identifying opportunities for energy conservation, streamlining operations, and reducing frequent breakdowns to achieve operational excellence. Piramal Group, with a commitment to inclusive growth and ethical practices, offers equal employment opportunities to all applicants and employees. Employment decisions are made based on merit, considering qualifications, skills, performance, and achievements, ensuring equal opportunity in all personnel matters. Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) providing end-to-end development and manufacturing solutions across the drug lifecycle. With a global network of facilities in North America, Europe, and Asia, PPS offers a wide range of services, including drug discovery solutions, process and pharmaceutical development, clinical trial supplies, commercial supply of APIs, and finished dosage forms. Specialized services such as highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products, and potent solid oral drug products are also offered. PPS is a trusted partner for innovators and generic companies worldwide, with experience across various technologies, making us the preferred choice in the industry.,

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com. Job Summary Storage and Dispensing of Packaging Materials. Job Responsibilities Supervise the PM sampling activities at LVMP as per the plan and arrange the material for Sampling. Dispensing of Packaging materials as per LVMP production plan as per standard operating procedure. Ensure the storage of packaging materials as per cGMP. Ensure the online documentation related to LVMP packaging material warehouse on daily basis. Phisical stock verification (Cycle counting) and update the stock in SAP. Maintain safety and good housekeeping practices at work place. Ensure the cleaning activities in working area / equipment and updated the logbboks online. Store in and Store out of materials in ASRS WMS system. Calibration of Roll Label Counting Machine as per standard operating procedure. Daily monitoring and recording of Temperature / relative humidity in working area. Performing calibration activity of weighing balance (daily and Fortnightly). To maintain the online documentation related to Warehouse activities on daily basis. Works in a safe mannar collaborating as a team member to achive all outcomes. Demonstrate behaviours thst exhibit our organizational Values: Collaboration, Courage, Perseverance and Passion. Continuous Up gradation of knowledge with respect to cGMP and regulatory guidelines. Performance all work in support of our Corporate Values of Collaboration, Courage, Perseverance and passion. Demonstrates strong and visible support of our values. Ensure personal adherence with all complaines programs including the Global Business Ethicsand compliance program, Global quality policies and procedures, Safety and Environment policies and HR policies. All other relevant duties as assigned. Job Requirements Education B.Com Knowledge, Skills and Abilities:- Good knowledge in MS office, SAP and ASRS Operations. Maintains good Interpersonal skills and communication skills. Flexible to work. Experience:- 11+years of experience in GMP regulatory industry. At Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed. We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation. Show more Show less

Work Your Magic with us! Ready to explore, break barriers, and discover moreWe know youve got big plans so do we! Our colleagues across the globe love innovating with science and technology to enrich peoples lives with our solutions in Healthcare, Life Science, and Electronics Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet That's why we are always looking for curious minds that see themselves imagining the unimaginable with us, Your Role Leadership & Strategy Manage Sourcing Projects of high complexity and collaborates in cross functional teams Actively lead the development of the global / regional sourcing strategies and initiatives Ensure and promote effective communication and co-operation within the Sourcing network (direct and indirect categories) Stakeholder management Establish close relationship with the Global/Regional stakeholders they regularly interact with as part of their sourcing/supplier management activities Engage in a consultative manner to develop value added opportunities and actively manage the demand Report regularly on their key results and activities May act as a Business Partner for Business or/and Operations at all levels of the organization including senior management level May act as a site lead for defined sites of medium to big size Sourcing Member or leader of the Category Team(s) functionally and collaborate in the strategy definition and objective setting process of the respective category Manage the portfolio being accountable for the savings development in their respective areas of responsibility, actively propose new saving projects Implement and conduct risk management process, and ensure availability of mitigation plans for key materials and/or services Lead/participate in strategic negotiations including agreements or strategic meetings with key suppliers Identify, qualify and develop best in class suppliers Actively contribute to Strategic Supplier Development as part of the SRM program Conduct supplier performance evaluations Run the sourcing projects in their area of responsibility, including the RFI/RFP process and participation in make-buy conversion decisions Ensure compliance with contract management process and other relevant SOPs Support the sustainability program within her/his area Organization efficiency Support and interact with the MBS/SBS organizations and ensure a transfer of information and tasks as needed Escalate issues as they appear to Sourcing Category team or Sourcing line manager Drive, promote and contribute to the 3S (stop, standardize and simplify) approach to increase efficiency in her/his area Who You Are Requires a graduate background plus substantial to extensive professional experience in relevant disciplines (mature professional >5 years) Requires advanced knowledge and experience in own discipline and beyond, Work experience preferably in a large multi-national organization in the Life Science or Medical Device industry, in a global, matrixed organization supporting and leading strategic sourcing/category management with minimal guidance Experienced performing in a fast-paced, goal oriented and time-sensitive environment Knowledge of manufacturing processes in the respective category preferred with understanding of cGMP manufacturing practices a plus Requires advanced to deep and/or broad knowledge and experience in own discipline and beyond which may also require advanced market knowledge, What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology We are committed to creating access and opportunities for all to develop and grow at your own pace Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity! Show

Long Description The person should have knowledge in Manufacturing equipments. He should have exposure in equipment’s such as FBE,Fette/KORSCH M/C & auto coater M/C. He should be able to handle equipment trouble shoot in Manufacturing department. He should have exposure in regulatory organization . He must have faced the USFDA ,MHRA & other regulatory audits. He should have the exposure in Caliber QAMS, elog, track wise ,SAP ,WIND ,CDAS & other software. He should have the exposure in process simplification/optimization ,SABA ,elog & SCADA. Competencies Education Graduation in Pharmacy Work Experience 3-6 years of experience in Fette compression machine

Role & responsibilities Ensuring the cleanliness and housekeeping activities in the laboratory. Ensuring the laboratory safety. Calibration of analytical instruments like High Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC). Analysis of raw material, in-process, finished product and stability samples using HPLC & GC. Analysis of vendor samples as part of vendor qualification. Analysis of cleaning samples using UV & HPLC. Analytical method validation, method transfer and verification analysis as per protocol. Analytical column performance and maintenance. Temperature and humidity daily check in HPLC room. Preferred candidate profile Analytical Chemistry Documentation skills GMP, cGMP/ GLP Skills Interpersonal skills 5S skills( Sort, Straighten, Shine, Standardize& Sustain)

The AGM / DGM Technical Services position requires a candidate with a B.Pharma / M.Pharma qualification and 15 to 20 years of experience in tech transfer activities of solid oral dosage forms for regulated markets. The ideal candidate should have experience in managing a team of 15 to 20 scientists, documentation officers, and technicians. As an AGM / DGM Technical Services in Kandivali, Mumbai, your responsibilities will include planning and executing scale-up and Exhibit batches of solid oral dosage forms for regulated markets such as US, EU, ROW, and Canada. You will be accountable for ensuring the timely initiation of stability studies for exhibit batches and overseeing the technical service area, specifically the Pilot batch area. Your role will involve reviewing all relevant documents for scale-up and Exhibit batches execution, such as BMR, BPR, Protocols, scale-up report, exhibit batches report, and providing filing documents to RA. You will collaborate with cross-functional teams including site manufacturing team (Production, QA, QC), R&D, RA, PDC, and Supply Chain to meet aggressive timelines for regulatory submissions and business priorities. In addition, you will be responsible for reviewing, approving, and effectively implementing change control proposals, deviations/incidents, and CAPA for scale-up and exhibit batches. Addressing deficiencies identified by regulatory agencies related to drug products and supporting the production department for validation batches and troubleshooting of commercial batches will also be part of your duties. It is essential to perform all job responsibilities in compliance with cGMP, SOPs, and other regulatory agency requirements to ensure quality and regulatory standards are met.,

As a Quality Control (QC) Analyst at Jubilant Generics, you will be responsible for various tasks related to ensuring the quality and compliance of pharmaceutical products. Your role will involve sampling and analyzing packing materials and raw materials, conducting in-process quality control, and preparing specifications and test procedures. Additionally, you will be responsible for maintaining artwork and shade cards, as well as calibrating and validating instruments and equipment. Your attention to detail will be crucial in recording analytical data accurately and preparing records of analysis for both raw materials and finished products, including stability samples. In this role, it is essential to uphold cGMP (current Good Manufacturing Practice) and GLP (Good Laboratory Practice) compliance at all times. You will also be involved in investigating deviations, incidents, and out-of-specification results, ensuring that corrective actions are implemented promptly. Furthermore, maintaining a clean and organized work environment is important, and you will play a key role in ensuring good housekeeping practices in the laboratory. Your contribution to these quality control processes will ultimately support Jubilant Pharma's commitment to delivering high-quality pharmaceutical products to customers worldwide. For more information about Jubilant Pharma and its operations, please visit www.jubilantpharma.com.,

As a quality control professional, you will be expected to strictly adhere to cGMP norms and safety rules within the factory premises. Your key responsibilities will include verifying logbooks, records, and other analytical documents on a daily basis to ensure their correctness and completeness. It will be your duty to ensure the timely preparation and revision of SOPs, STPs, and other Quality Management System (QMS) documents. You will also be responsible for the prompt completion of investigation activities related to Quality Control (QC) aspects such as Out-of-Specification (OOS), Out-of-Trend (OOT), deviations, and out-of-compliance (OOC) activities. Moreover, you will be accountable for the implementation of Corrective and Preventive Actions (CAPAs) as identified, ensuring their completion within the set timelines and evaluating their effectiveness. Additionally, you will prepare and revise calibration and preventive maintenance schedules as per the requirements of the facility. Your role will involve overseeing the calibration of instruments and equipment, both internally and externally, as per the defined schedule and maintaining proper documentation for the same. It will also be your responsibility to review audit trails for all application software used in the QC department to ensure sustained compliance with regulatory standards. Furthermore, you will review documents related to the qualification of working standards and reference standards, ensuring their accuracy. You will also be involved in the preparation and review of protocols for stability studies, instrument/equipment master lists, and quality risk assessments as needed. In the absence of the Deputy General Manager (DGM) or Deputy Chief Manager (DCM) of Quality Control, you may be required to deputize for them and undertake any specific tasks assigned by the Head of Quality. Your role is crucial in maintaining the quality standards and regulatory compliance within the organization.,

Summary Independent Project work less complexity, e.g. early phase projects. Lead or support smaller and less complex projects or support more complex projects with mentoring. Higher complex routine tasks e.g. failure investigations and deviation, change controls etc. Manage projects and processes to support departmental portfolio, projects and objectives according to agreed timelines and standards. Ensure that compliance with cGMP is maintained in TRD. About The Role Key Responsibilities Support a discipline and/or provide a service individually or within a team of associates. May provide functional expertise to Line Unit and other QA Units in area of responsibility Write review, decide on approval and/or release of GMP-relevant deliverables and/or related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables. Manage project related activities (e.g. TRD product portfolio, development of new tools, processes, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities, qualification and facility upgrade activities, IT validation projects) as per area of responsibility. Support Project management functions as a project team member. Provide support to TRD line functions in GMP related topics as per area of responsibility. Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.). Manage a Design History File / Tech File portfolio of assigned Medical Device/ Drug Device Combination projects from Quality perspective and provide functional expertise in responsibility for medical devices and combination products in cross-functional project teams to assure cGMP Compliance with medical device specific regulations (ISO 13485:2016, EU MDR, 21 CFR 820 and 21 CFR Part 4) and internal Novartis standards for Medical Device development products under submission and Life Cycle Management activities. He/She ensures the quality specific tasks of a Design History File and follow-up including supporting medical device reporting to regulatory authorities. Monitoring, analysis, and reporting of GMP related KPIs as part of management reporting, Review QA agreements for Medical Device projects. Coordinate complaint investigations for Medical Device projects. Review of release documentation for medical device components. Support PMS activities for Medical Device projects. Support QMS and Audit (external and internal) activities Minimum Requirements Masters, Bachelor/Technician (> 5 years pharma) Fluent English required (oral & written) Good skills in site (local) language desired. Good knowledge of cGMP, working knowledge in technical development, production or QA. Sound scientific, technical and regulatory knowledge. Good organizational and decision-making skills. Good and proven ability to analyze and evaluate cGMP compliance. Commitment To Diversity And Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [HIDDEN TEXT] and let us know the nature of your request and your contact information. Please include the job requisition number in your message 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 well help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less