146 Parenteral Jobs - Page 6

Roles & Responsibilities You will be responsible for end to end Formulation development of Injectable including development, execution, filing and approval. You will be responsible to co-ordinate closely with analytical team to devise effective Proof of Concept (POC) for developing generic equivalent of Reference Listed Drug (RLD)/generic Injections. You will be responsible to support in scale-up to pilot/plant scales for Injectable Products. You will be responsible to monitor the development for robust, effective and bioequivalent drug product in timely manner adhering to safety and quality standards. Also provide support in documentation for regulatory submissions. You will be responsible for technology transfer and execution of the batches. You will be responsible for performing pre-formulation studies for material characterization, drug-excipient compatibility and Reference Listed Drug (RLD) characterization (including reverse engineering, formulation designing and optimization, processes designing and scale up). You will be responsible for preparation of risk evaluation and risk mitigation documents, Scale-up batch documents, and filing documents for drug product at every stage of development. You will be responsible to review data generated and participate in discussions with experts to conclude on prototype(s). Participate in strategizing the sourcing of Active Pharmaceutical Ingredient (API), raw materials and ensure development studies are performed related to regulatory and internal system requirements. You will be responsible for designing and implementing stability studies for injectable formulations to ensure product quality and shelf life. You will be accountable for troubleshooting formulation and process-related issues during development and manufacturing stages. You will collaborate with cross-functional teams to ensure alignment of formulation development with regulatory requirements and commercial objectives. You will be responsible for staying current with emerging technologies and regulatory guidelines in injectable drug development and incorporating them into your work. You will mentor junior scientists and contribute to the continuous improvement of the formulation development process. Qualification Educational qualification: Masters in Pharmaceutical/M.Tech in Chemical Engineering Minimum work experience: 5 to 8 years of experience in pharmaceutical company in Injectable products. Skills & attributes: Technical Skills Have work experience on Formulation Development and expertise in inhalation/injectable dosage form. Experience in areas of product development for Generic Injectable Experience in Quality by Design (QbD). Experience in Process Optimization and scale up. Experience in Operational Excellence. Knowledge on Good Manufacturing Practice and Good Laboratory Practice. Experience in Technology Transfer. Behavioral Skills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Ability to work collaboratively with own team and cross-functional teams. Additional Information About the Department Integrated Product Development Organisation We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

Job Summary We are seeking a dynamic and experienced Production Shift Chemist in Active Pharmaceutical Ingredient (API) to support the development of robust and cost effective API's by executing scale up batches for all new and existing APIs at GMP Kilo Lab. Roles & Responsibilities You will be responsible for Equipment Operations of Reactors (GL, SS & All Glass), Mobile Receivers & tanks, ANFD, PNF & VTD, Isolators (Reactor Charging, ANFD Discharge, Dispensing/packing, sifter & multimill), Air jet mill, Multimill, Blender & Sifter, Spray dryer, TCU, Vacuum Pumps, AODD Pumps, centrifugal pumps & peristatic pumps, VNS sealing machine, RLAF & dispensing booth, Refrigerators and Deep freezers etc. You will be responsible to Execution of Batches, Equipment product change over & General cleaning of equipment. Batch production record filling as per SOP & as per Good documentation practices. You will be responsible for Filling of Equipment Logs, daily production monitoring records like Temperature, Humidity & RH, weighing balance calibrations, reviewing of house keeping records, Printing Data logger records and Updating status boards etc as per site SOPs. Collection of Records/books, submission of completed BPRs/Records to QA. You will be responsible for In process sample collection from Reactors, ANFD & VTD etc. Raw Material, Solvents handling, material moments & dispensing and maintaining records as per SOP. You will be responsible to reduce the accidents in the plant by following safety principles, install earth rods to remove static electricity from material, Handling different chemicals with appropriate PPE & following SHE Norms. Monitor adherence of behavioral safety of contract persons. You will be responsible to meet the production schedules and reduce breakdowns by planning the equipment for idle condition to prepare for preventive maintenance, issue work order to maintenance to carry on with maintenance, follow up with maintenance on problem rectification. You will be responsible for Handling of Production waste & Detoxification batches execution. Support the engineering team in equipment qualification activities to meet the batch planning. You will be responsible for handling, initiation of deviations, incidents and support for closure of deviation & Incident reports Qualification Educational qualification: B.Sc Chemistry, M.Sc Chemistry & Diploma in Chemical engineering Minimum work experience: 2-6 years of experience in Pharma industry Skills & attributes: Technical Skills Experience on Process of Product Development Knowledge in API chemical Process & equipment. Knowledge of unit operations. Knowledge in Safety, Health and Environment guidelines (SHE) guidelines. Experience in data entry in SAP system. Behavioural Skills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Ability to work collaboratively with own team and cross-functional teams. Additional Information About the Department Integrated Product Development Organisation We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

Job Description : - Department - Injectable Mfg & Packing Position - Technician / Officer / Sr. Officer Exp - 2 to 6 Education - ITI / Diploma Eng / D.Pharma / B.Pharma / M.Pharma Skill Set - Require good knowledge in Complex Skid / NDDS / Aseptic (PFS / Vials Liquid) / Autoclave/ Lyopholizer / Batch Manufacturing, Sterile Secondary Packing and track and trace activity + visual inspection activity. Department - QC ( QC FG / Stability / AMV ) Position - Officer to Executive Exp - 2 to 7 Education - M.Sc / B.Pahrma / M.Pharma Skill Set - Analyst : Finished, AMV & Stability Section. knowledge of Instrument - HPLC / GC. Preferably know-how of Chromeleon Software Department - Engineering ( Plant Maintenance Sterile / Instrumentation Sterile ) Exp - 2 to 15 Position - Technician / Executive / Assistant Manager / Manager Education - Diploma Eng / ITI / B.Tech Skill Set - Have good exposure in Plant Maintenance & Instrumentation related work in sterile facility Department - QA ( IPQA / Qualification (Sterile Background Only) Position - Officer to Executive Exp - 2 to 7 Education - B. Pharmacy / M.Pahrma / M.Sc Skill Set - Have good exposure in Sterile IPQA & Sterile Qualification Related activity Department - Lab QA Position - Officer to Sr. Executive Exp - 2 to 9 Education - B. Pharmacy / M.Pahrma / M.Sc Skill Set - Having good exposure of QC QMS handling , Lab instrumentation & audit trails. Have strong background of Lab QA activity. Department - Solid Oral Packing Position - Technician / Officer / Sr. Officer Exp - 2 to 5 Education - ITI / Diploma Eng / D.Pharma / B.Pharma Skill Set - Require good knowledge in Primary & Secondary Packing, Track & Trace, Carton Packing Machine (CAM HV1 Model), Online Documentation BPCR / Logbook etc.

Roles and Responsibilities Assist in production activities such as BMR, sterilization, dispensing, mixing, formulation, and parenteral operations. Monitor and control process parameters to ensure compliance with quality standards. Maintain accurate records of production data and batch logs. Collaborate with team members to resolve issues and improve productivity. Ensure adherence to cGMP guidelines and company policies. Desired Candidate Profile Strong understanding of BMR, sterilization techniques, dispensing procedures, mixing processes, formulation development, and parenteral manufacturing principles. Ability to work effectively in a fast-paced environment with attention to detail and ability to multitask.

Help in Day To Day Production Of Pharmaceutical Products Manpower Allocation For Smooth Working In Shift Supervision Of Production Activity BMR And BPR Report Preparation Data Preparation For Internal And External Audit -IE. US FDA - EU GMP Etc Required Candidate profile B. Pharm - M. Pharm - B.Sc - M. Sc Experience In Production Or Packaging Working Experience US FDA Approved Plant is Desirable FDA Approval in Tablet - Capsule Or Any will be an added advantage

Help in Day To Day Production Of Pharmaceutical Products Manpower Allocation For Smooth Working In Shift Supervision Of Production Activity BMR And BPR Report Preparation Data Preparation For Internal And External Audit -IE. US FDA - EU GMP Etc Required Candidate profile B. Pharm - M. Pharm - B.Sc - M. Sc Experience In Production Or Packaging Working Experience US FDA Approved Plant is Desirable FDA Approval in Tablet - Capsule Or Any will be an added advantage

Roles and Responsibilities Review of technical regulatory documents for drug substance and drug products Compilation of CMC data for submission to regulatory authorities Review and approval of master documents for CMC segments Preparation and review of annual reports, amendments, supplements etc. Assist with CMC responses to regulatory authorities queries during development, registration, and product lifecycle. Evaluation and co-ordination of change controls Liaison with various departments like R&D, QC, QA, Production, stability departments for obtaining documents. Prepare response to regulatory deficiencies letters according to US regulatory requirements. Desired Candidate Profile The candidate should have adequate knowledge in regulatory affairs (Injectable or Ophthalmic formulations) for US market. He/ She should have 3 - 5 years of experience with B. Pharm./ M. Pharm./ M. Sc. as a educational qualification. Candidate should possess excellent verbal and communicational skills.

Multiple positions open for various operators who are responsible to operator vial filling/ sealing machine, autoclave, ampoule filling machine, manufacturing of injectable.

Essential Duties and Responsibilities: Actively Support launch and sustenance of Baxter commercial products globally by following the Baxter Quality Management Systems. Assist in the management of the Baxter product design throughout the product lifecycle and maintenance of the product DHF, or similar product design governance documents for a particular product family. Identify and analyze design problems to achieve optimal solutions that satisfy cost and technical requirements. Formulate new, innovative approaches to solve technical problems on a consistent basis. Actively involve in commercialized product investigation, execute batches in laboratory, prepare report to support the investigation. Involve in compendial product change/proposal discussion, assess the proposed change impact on the product quality & patient safety. Provide support to analytical team by providing the required product solution/placebo solution samples. Execute batches in laboratory, assess the study outcome to support the compendial product change requirement. Ensure response to customer queries, agencies query, market compliance. Design and execute batches/experiments in laboratory, prepare report to support queries/market compliance. Responsible for ensuring the availability of required licenses and materials (raw material, packaging materials) in laboratory. Qualifications: Educational Qualification: Masters in Pharmaceutics or equivalent Hands on experience in laboratory batch execution and drive the towards the expected result. Good communication skills for effective liaison and teamwork Problem-solving skills, analytical skills and attention to detail Excellent organizational skills and the ability to work on several tasks or projects concurrently Presentation skills - for presenting ideas and findings to colleagues and customers Ability to work well independently, with minimum supervision Drive, enthusiasm and self-motivation

. Identify, evaluate, and develop suppliers Negotiate contracts, pricing, and delivery timelines. Track purchase orders and coordinate timely delivery of materials. Required Candidate profile Candidate should have experience of Purchase of Finished Products for Pharma Company. If interested, please call at: 7742408300/ 9999190672 & mail your resume at: lksaddiassociate@yahoo.co.in Perks and benefits Salary will not be constraint for right candidate.

Sterile Operations Trainer Grade: G9 Designation: Senior Manager Location: Halol 1 Job Description: Education: B. Pharm / M. Pharm Overall responsibility of Aseptic Training Academy (ATA), Baska To plan, develop, and execute training at Aseptic Training Academy (ATA) - Sterile Operations for Sun Global Operations (SGO) Training. Creation of simplified training modules for technicians, scheduling and execution of training Creation of training evaluation and/or feedback systems Course creation according to levels (Level 1 - Technicians, Level 2 - Supervisors and above, Level 3 - Managers and above) pertaining to sterile operations Planning, scheduling & execution of technical training program relevant to sterile operations for new recruits/for existing employee by self/internal or external facility Identification of Certified trainer at various locations (sterile operations) based on additional training need of respective location Coordination with location head and Subject Matter Expert (SME) for conducting the additional training program according to training calendar on monthly basis pertaining to sterile operations To prepare and submit SGO training score card for sterile operations on monthly basis after plant review to Corporate Quality Policy and Training department (CQPT) To maintain the training records of training Periodical review of technical courses along with business units for site specific course and the head of course for suitable course content / design and pedagogy up gradation To coordinate in technical course scheduling and publishing of calendars and facilitate visiting faculty/guest faculty in course delivery Any other work assigned by superiors from time to time

Role & responsibilities Operate and manage freeze drying and lyophilization equipment , including Freeze Dryer, Palltronic Integrity Tester, and CLU. Ensure smooth functioning of computerized systems such as eBMR, PLC, SCADA , and manage data integrity, audit trails, and system backups. Participate in equipment and area qualification/requalification activities, including LAF (Laminar Air Flow) systems. Ensure adherence to and documentation of Change Controls , Risk Assessments (RA) , Corrective and Preventive Actions (CAPA) , and EHS (Environment, Health, and Safety) protocols. Ensure compliance with regulatory standards and assist during audits and inspections . Maintain accurate and timely documentation as per GMP guidelines. Preferred candidate profile Bachelors degree in Pharmacy (B. Pharma) – Mandatory 4 to 7 years of experience in a sterile pharmaceutical manufacturing environment , specifically in Lyophilizer operations . Strong understanding of pharmaceutical regulatory standards , including GMP, FDA, MHRA, etc. Familiarity with automation and computerized systems like eBMR, SCADA, PLC. Sound knowledge of qualification protocols , equipment handling , and process controls . Excellent documentation and communication skills. Proactive, team-oriented mindset with the ability to handle audits and cross-functional coordination.

Must have Exp in Injectable & Parenteral formulations. Lead and optimize end-to-end sterile injectable production, ensuring cGMP compliance, on-time delivery and continuous process improvement.

Company: Leeford Healthcare Ltd. https://www.leeford.in/ https://www.linkedin.com/company/1464125/admin/dashboard/ Role: Production Manager Sterile Prep (Eye/Ear Drops) Experience: Minimum 8-12 years Location: Baddi Education: Graduation; Post Graduation: BSC/B.Pharma Desired Candidate Profile: Required experience of 8-12 years, Exposure to work with one or more reputed organization. Knowledge of Sterile manufacturing like Eye Drops & Ear Drops i.e. Manufacturing, Filling, Sealing and packing of products. Job Description: Designation: Production Manager Sterile Prep (Eye/Ear Drops) Work Profile: 1. Responsible for Batch Manufacturing in SVP line, aqueous line. 2. Responsible for operating of Autoclave. 3. Responsible for filling operation In SVP line- Vial /Ampoule. 4. Responsible for Trend Data entry of Filling Rejection, Filling Yield, Packing Yield & Batch Yield. 5. Responsible for Product sterilization with Rotary Sterilizer for Emulsion and Steam air Sterilization for Aqueous product. 6. Responsible for maintaining the all record according to gmp compliance. 7. Must have experience of handle Ampoule leak test machine. 8. Must have working experience of aseptic filling area. Interested one can share resume to talent@leeford.in or can whatsapp to 9875961129

Novo Nordisk Global Business Services (GBS) India Department: GCM DP RoW Location Hyderabad, India Are you an experienced aseptic manufacturing project manager with a strong technical background and a passion for making a direct impact on patients'' livesDo you thrive in an international environment where cultural awareness is key to your successIf so, this could be your dream role! ApplyNow! The Position As a Project Manager in Aseptic Manufacturing, you will lead and mentor cross-functional teams, including both Novo Nordisk and our Contract Manufacturing Organisation (CMO) partners. It includes, Ensure the seamless Technology Transfer and manufacturing of our commercial products, always upholding Novo Nordisk''s stringent quality standards and adhering to cGMP and regulatory requirements. Lead and manage aseptic manufacturing projects, specifically leveraging your expertise in areas like Formulation/Compounding, Filling, Washing & Sterilisation, Environmental Monitoring, or Clean Utilities. Developing and managing detailed project plans and timelines and communicating effectively with steering groups and key stakeholders. Monitoring progress and proactively securing necessary resources. Developing project risk grids and identifying mitigation strategies with both Novo Nordisk and our Contract Manufacturing Organisation (CMOs). Qualifications Bachelors or Masters degree in engineering. Possess experience of 5-12Years of project management experience with a proven track record of successful project delivery in a highly regulated environment, especially internationally. Aseptic manufacturing experience is a must, and experience with Technology Transfer of biologics is a significant advantage. Professional experience balancing individual drive with effective stakeholder involvement. Proficiency in project management software (e.g., MS Project, Smartsheet, Jira, or equivalent). Demonstrated fluency in written and spoken English is essential. About the Department GCM DP RoW Projects is a dedicated team committed to providing life-saving insulin and GLP-1 to patients in regions such as Africa, India, the Middle East, and Asia. By partnering with CMOs in these areas, the department strives to make a meaningful impact on the quality of life for patients living with diabetes and obesity. Our projects are tailored to meet the unique requirements of each country, offering exciting growth opportunities. With a steadfast commitment to innovation and problem-solving, we work to overcome challenges and navigate complex regulatory landscapes to deliver insulin and GLP-1 on a global scale. Join us in making a difference.

Novo Nordisk Global Business Services (GBS) India Department GCM DP RoW Job Location Hyderabad Are you an expert in aseptic manufacturing with a strong quality mindset and a desire to make a tangible impact on global healthNovo Nordisk is seeking a dedicated Manufacturing Specialist to join our Global Contract Manufacturing Drug Product (GCM DP) team in Hyderabad, India. In this role, you''ll be crucial in ensuring the high-quality production of life-saving insulin and GLP-1 products through our Contract Manufacturing Organizations (CMOs). ! The Position As a Manufacturing Specialist (SME), you''ll be the go-to expert driving Technology Transfer projects for commercial products, ensuring top-tier quality with our Contract Manufacturing Organizations (CMO) partners. Your key responsibilities will include: Lead cross-functional teams, ensuring seamless collaboration between Novo Nordisk as the sending Unit and Contract Manufacturing Organizations (CMOs) partners as the receiving Unit. Act as a mentor and support Contract Manufacturing Organizations (CMOs) to ensure Novo Nordisk products are manufactured to the highest quality standards. Provide training, share best practices, and review and approve validation documents to safeguard compliance. Offer oversight and support during the planning and execution of validation and qualification activities. Define, manage, and deliver on complex projects in collaboration with CMOs, Quality Assurance, and project managers. Drive problem-solving initiatives and provide scientific and technical solutions within tight project timelines. Qualifications Bachelors /Masters degree in engineering. Possess 10+Years experience and relevant 5 years of manufacturing experience, especially in an international, multicultural environment. Expertise in aseptic manufacturing processes is non-negotiable. Capable of communicating naturally and effectively with stakeholders at all levels with adept at finding solutions and motivating stakeholders to achieve ambitious goals. Possessing a strong mindset, a focus on continuous improvement, and keen attention to detail. Demonstrates the ability to work independently with minimal supervision, a strong willingness to learn new skills, and the motivation and flexibility to thrive in a fast-paced, dynamic environment. About the Department GCM DP RoW Projects is dedicated to delivering life-saving insulin and GLP-1 to patients in regions such as Africa, India, the Middle East, and Asia. By partnering with CMOs in these areas, the department plays a pivotal role in improving the quality of life for patients living with diabetes and obesity. With a focus on Market Access initiatives, the team tailors projects to meet the unique requirements of each country, offering exciting growth opportunities. The department thrives on innovation and problem-solving, overcoming challenges and navigating complex regulatory landscapes to deliver insulin and GLP-1 on a global scale. Based in Hyderabad, India, youll join a diverse and dynamic team committed to making a difference.

Job Role : Block Head (Engineering) Grade : Senior Manager Location : Guwahati Experience : 15+ Years (experience in lyophilizer ) Qualification : BE. Instrumentation Overseeing the engineering functions of parenteral block. Coordination with production personnel, contractors & machine manufactures to sort out machine related problems, major and minor modifications for smooth running in process. Tracking and maintaining the critical spares required for preventive and routine maintenance Planning various maintenance schedules and lead the team of engineering to ensure implementation of the schedules with the help of junior sub-ordinates for improving the overall reliability of the equipments. Inspect equipment and components to identify hazards, defects and the need for adjustment or repair to improve overall efficiency of the system and equipment. Provide safe working environment for staff & systems with zero accident. Responsible for sourcing of machine tools consumable parts and related services and interacting with user departments for analyzing the required material. Facing customer audits and taking corrective actions as per audit requirements. Preparing reports on maintenance performance and technical data of various equipments, spare parts, labour and machines for resources planning, budgeting, scheduling & execution of operation and maintenance activities. Executing cost saving and energy saving techniques & modifications to achieve substantial reduction in expenditures and work within the budget. Monitoring & Maintenance of EMS, BMS, Fire Detection and Door Interlock System, Process equipment and machine. Diagnose malfunctioning systems, apparatus and components using test equipment and hand tools to locate the cause of a breakdown and correct the problem. Provide prompt response to user whenever there is a breakdown and resolve the issue as quickly as possible. Ensure that equipments are in good working order so as to prevent disruption of activities during process/production. Keep record of all stock and supplies of all spares, items, instruments and assist the management in forecasting requirements and scheduling expenses to maintain the consumables. Working in collaboration with the production team to formulate the best cost-effective manufacturing process. Attend new training programs in order to increase knowledge of trends and best practices in industry. Support the company in increasing profitability by managing resources efficiently and making necessary recommendations. Handling QMS tools and support team to complete all the action within timeline. Participate in all EHS programs and share all EHS activity to make awareness into sub-ordinates and technicians. Follow GEP in daily work culture in build enhance performance and efficiency of equipment, system and organization Follow GMP practices, schedule and SOPs. Responsible for Calibration, Validation, Qualification Protocol & Reports.

Role & responsibilities Oversee the maintenance, operation, and improvement of pharmaceutical manufacturing facilities and equipment. Continuously improve manufacturing processes to enhance efficiency, reduce costs, and maintain high product quality. Ensure that all engineering activities comply with relevant industry regulations, such as those from the FDA Reduce Down time of Machinery Timely Process maintenance, Preventive Maintenance Co-ordinate with Vendor for necessary Equipment Look after Utility, Process Maintenance & ETP Monitoring , Guiding Manpower Preferred candidate profile Candidate must have Experience into Injectable & Lyo

Hi, We have urgent position open for the Warehouse Executive / Junior Executive role. Responsible for managing the receipt, storage, issuance, and documentation of materials (raw, packaging, and finished goods) in compliance with cGMP, GDP, and company SOPs. Ensures material traceability, cleanliness, and timely supply to production particularly for sterile/injectable operations. Key Responsibilities: 1. Material Handling & Storage 2. Documentation & Compliance 3. Material Issuance 4. Cleanliness & Safety 5. Vendor Coordination & Dispatch (Optional)

Job Role: Junior Associate to Senior Associates Manufacturing (Injectables) Eligibility criteria: Qualification: Any Diploma/BSc/B.Pharma/MSc/M.Pharma Years of Experience: 2 to 10 Years should be from injectable manufacturing plant. Job Description Operate production equipment such as Injectable , Sterile , Parenteral machines, Vial / Ampoule filling , Capping , Compounding , Washing ,Sealing, Terminal sterilization, Stopper process & Visual inspection. Monitor and control the production process to ensure quality products are produced within specified parameters. Maintain accurate records of production data and perform routine maintenance tasks on equipment as required. Collaborate with other team members to resolve issues and improve overall efficiency. Ensure adherence to Good Manufacturing Practices (GMP) guidelines. Must have experience with USFDA regulatory environment & process.

Qualification: Post-graduate in Pharmacy or Pharmaceutical Engineering Experience: 15 to 20 years in sterile manufacturing plant operations, with a minimum of 10 years in a leadership role and at least 7 years in a regulated sterile manufacturing environment. About The Company Fresenius Kabi Oncology Limited, a wholly owned subsidiary of Fresenius Kabi, is a leading player in the oncology generics market with a broad portfolio that includes injectables, cytotoxic, and APIs. Its state-of-the-art production facility in Baddi features dedicated units for cytotoxic and non-cytotoxic products, including liquid and lyophilized injectables. The facility is approved by global regulatory authorities such as EMA, ANVISA, and Health Canada, and its products are registered in over 30 countries. About The Role As Site Head of the Baddi facility, you will oversee and be responsible for all aspects of site manufacturing operations. This leadership role is pivotal in ensuring operational excellence, regulatory compliance, and strategic alignment with the global oncology supply chain. You will be responsible for driving performance, fostering a culture of continuous improvement, and leading a cross-functional team toward sustainable and efficient operations. The potential candidates should be result-driven, resilient, collaborative and empathetic. About the Responsibilities Strategic Leadership: Lead the end-to-end operations of the sterile injectable plant, including production, quality, engineering, supply chain, and EHS functions. Regulatory Compliance: Ensure full compliance with internal and external regulatory standards (e.g., EU-GMP, WHO-GMP) and corporate SOPs. Operational Excellence: Drive continuous improvement in manufacturing efficiency, cost optimization, and product quality. Oversee the implementation of digitalisation, such as optical inspection and serialisation. People Management: Build and lead a high-performing cross-functional team. Foster a culture of accountability, safety, and innovation. Project Execution: Oversee capacity expansion, technology transfer, and commissioning of new lines (e.g., lyophilization, isolator-based filling systems). Stakeholder Engagement: Collaborate with corporate leadership, regulatory bodies, and cross-functional teams to align plant goals with organizational objectives.