Are you a Junior Engineer - Maintenance passionate about ensuring that process is completed in a timely and efficient manner? If so, this opportunity could be for you! Join us in Hyderabad at Oyster Medisafe, a pioneer in medical devices, where your skills and experience will be recognized and celebrated. Take the next step in your career with us and help shape the future of healthcare! As a Junior Engineer - Maintenance at B. Braun Group you will play a vital role maintaining efficient production processes for the manufacturing of our high-quality medical products. Your key responsibilities: Plan and execute repair, maintenance, and installation of machines, tools, and utilities to ensure continuous production. Identify and resolve breakdowns promptly, using technical documentation and tools effectively. Implement and adhere to preventive maintenance schedules, and suggest equipment upgrades for improved performance. Enforce safety procedures within the team and ensure adherence to health and safety guidelines. Manage spare parts procurement and collaborate with engineering and external suppliers. What you will bring to the team: Diploma in Electrical and Electronic Engineering. What sets B. Braun apart? Oyster Medisafe Pvt. Ltd., a B. Braun group company in Hyderabad, manufactures CE certified hypodermic syringes, needles and IV sets. Our products are used in hospitals, private practices, and emergency services, establishing us as a key player in the medical device industry. Our core values of Innovation, Efficiency, Sustainability, Trust, Accountability, and Diversity foster a performance-driven culture where we challenge each other constructively to grow personally and professionally. Recognized through awards such as 'Dream Companies to Work For' and 'Great Place to Work,' we invite you to join our team driven by a shared vision - to protect and improve the health of people around the world. What can we offer you? Convenient transport and subsidized canteen services. Mediclaim and Life Insurance. Learning programs and workshops to drive your development. Mental Wellness Support with counselling and mindfulness sessions. Paternity & Birthday Leave for life’s special moments. Fun activities and team building events. What’s next? Upon receiving your application, our dedicated Talent Acquisition team will review your application. If you stand out, you’ll be invited to engage in dynamic interviews, ranging from phone calls to video chats and in-person meetings. Throughout this process, we will keep you informed and inspired with regular updates and feedback. Finally, if you shine through and decide to join us, we will lead you into our seamless onboarding experience. Join us and be part of something extraordinary! We appreciate different perspectives, thoughts, experiences and backgrounds. By strengthening an appreciative, inclusive, respectful and equal working environment, we create a culture in which all our employees feel free to be who they are. To find out more about our commitment to diversity click here Check us out on Social Media! B. Braun Group LinkedIn B. Braun India Facebook B. Braun Group YouTube Show more Show less
Job Title: Junior Engineer / Sr. Engineer – Engineering Job Family: Engineering Reporting to: Manager – Engineering Location: Dabilpur, Hyderabad. About The Company B. Braun was founded in 1839 and is operating for more than 184+ years in the healthcare industry. The company has a presence in 64 countries with a global turnover of more than 8 Billion Euros. It employs around 56,000 people worldwide. Sharing Expertise is our promise to share, effectively utilize and commit to expanding medical knowledge and expertise in healthcare through dialog with our partners. The management & the employees worldwide have committed themselves to this promise. The key to our success is high degree of innovative drive coupled with creativity of highly-qualified workforce, adoption of technology, quality of care and products for healthcare workers and patients’ safety. B. Braun’s operations in India started as a subsidiary in the year 1984. Since inception the company has made rapid strides in the Indian healthcare market. B. Braun India has sales operation spread across the country with direct representation in more than 2000 hospitals. Through its expert sales force, B. Braun engages with more than 10,000 medical professionals in large corporate hospitals and many teaching colleges. B. Braun’s nationwide presence with over 500 channel partners spread across the country, helps to service customers faster and in an efficient manner. The company operates through four business divisions: Hospital Care, Aesculap, Avitum and the Out-Patient Market. For more information visit www.bbraun.co.in. B. Braun has acquired Oyster Medisafe Pvt. Ltd in 2011. Oyster Medisafe Pvt. Ltd has been producing syringes, needles and IV sets in India since 2007. Approximately 400+ dedicated employees work in the facility to produce medical devices used in clinics, private practices and emergency services, making Oyster Medisafe a leading manufacturer. 1.0. Key Responsibilities Must have a working experience in shifts in utility area in pharma company. Responsible for the operation & maintenance of Air Compressor. Responsible for the operation & maintenance of Chiller. Responsible for the operation & maintenance of Air Handling Units. Responsible for the operation & maintenance of DX unit. Must have a knowledge of area classification as per GMP. Should have a maintenance experience of production area machines in medical devices/Pharma industry. Responsible for the operation & maintenance of RO system. Responsible for the operation & maintenance of ETP and STP. Responsible for ensuring zero breakdown in Plant. Responsible for sharing breakdown report with team. Responsible for completion and maintaining Breakdown intimation slip record. Responsible for analysis of breakdown to find out the root cause. Responsible for attending breakdown with the help of electrician/ fitter as per the suitability of breakdown during shift. Responsible for initiation, follow up for closure of RGP. Responsible for preparation and circulation of daily MIS report of utility section. Responsible for ensuring zero non-conformance in facility during shift. Responsible for ensuring GMP implementation in plant during maintenance activity. Responsible for coordinating section heads for minimum spare parts inventory. Responsible for maintaining spare parts of production equipments. Evaluating and maintaining the MTTR & MTBF data of all plant equipments. 2.0. KRAs & Specific Roles Responsible to maintain zero breakdown in plant due to Mechanical related issues. Responsible for maintaining sufficient minimum spare parts inventory of all above mentioned equipment to minimize breakdown. Responsible for Maintenance of all Injection molding, needle assembly & IV set assembly machines, Packing area machines & instruments. 3.0. Key Competencies: Capable in attending breakdowns of production machines used in the plant. Capable to read the Engineering drawing i.e Machine layout / P & I diagram. Familiar with the Mechanical sealing of the machines. 0. Educational Qualification and Experience Education : B-Tech Mechanical Engineering Experience : 3-4 Years 5.0. Revision History Version Change Effective Date 1.0 New Document 2020-08-07 2.0 Changed into new template 2023-08-07 6.0. Approval Prepared By: Name: Bhupender Bhardwaj Position: Manager - Engineering Date: 2023-09-27 Checked By: Name: Position: Date: Approved By: Name: Ramesh Pawle Position: VP-Operations Date : Accepted By : Name: Emp. No: Date: Job Title: Junior Engineer / Sr. Engineer – Engineering Job Family: Engineering Reporting to: Manager – Engineering Location: Dabilpur, Hyderabad. About The Company B. Braun was founded in 1839 and is operating for more than 184+ years in the healthcare industry. The company has a presence in 64 countries with a global turnover of more than 8 Billion Euros. It employs around 56,000 people worldwide. Sharing Expertise is our promise to share, effectively utilize and commit to expanding medical knowledge and expertise in healthcare through dialog with our partners. The management & the employees worldwide have committed themselves to this promise. The key to our success is high degree of innovative drive coupled with creativity of highly-qualified workforce, adoption of technology, quality of care and products for healthcare workers and patients’ safety. B. Braun’s operations in India started as a subsidiary in the year 1984. Since inception the company has made rapid strides in the Indian healthcare market. B. Braun India has sales operation spread across the country with direct representation in more than 2000 hospitals. Through its expert sales force, B. Braun engages with more than 10,000 medical professionals in large corporate hospitals and many teaching colleges. B. Braun’s nationwide presence with over 500 channel partners spread across the country, helps to service customers faster and in an efficient manner. The company operates through four business divisions: Hospital Care, Aesculap, Avitum and the Out-Patient Market. For more information visit www.bbraun.co.in. B. Braun has acquired Oyster Medisafe Pvt. Ltd in 2011. Oyster Medisafe Pvt. Ltd has been producing syringes, needles and IV sets in India since 2007. Approximately 400+ dedicated employees work in the facility to produce medical devices used in clinics, private practices and emergency services, making Oyster Medisafe a leading manufacturer. 1.0. Key Responsibilities Must have a working experience in shifts in utility area in pharma company. Responsible for the operation & maintenance of Air Compressor. Responsible for the operation & maintenance of Chiller. Responsible for the operation & maintenance of Air Handling Units. Responsible for the operation & maintenance of DX unit. Must have a knowledge of area classification as per GMP. Should have a maintenance experience of production area machines in medical devices/Pharma industry. Responsible for the operation & maintenance of RO system. Responsible for the operation & maintenance of ETP and STP. Responsible for ensuring zero breakdown in Plant. Responsible for sharing breakdown report with team. Responsible for completion and maintaining Breakdown intimation slip record. Responsible for analysis of breakdown to find out the root cause. Responsible for attending breakdown with the help of electrician/ fitter as per the suitability of breakdown during shift. Responsible for initiation, follow up for closure of RGP. Responsible for preparation and circulation of daily MIS report of utility section. Responsible for ensuring zero non-conformance in facility during shift. Responsible for ensuring GMP implementation in plant during maintenance activity. Responsible for coordinating section heads for minimum spare parts inventory. Responsible for maintaining spare parts of production equipments. Evaluating and maintaining the MTTR & MTBF data of all plant equipments. 2.0. KRAs & Specific Roles Responsible to maintain zero breakdown in plant due to Mechanical related issues. Responsible for maintaining sufficient minimum spare parts inventory of all above mentioned equipment to minimize breakdown. Responsible for Maintenance of all Injection molding, needle assembly & IV set assembly machines, Packing area machines & instruments. 3.0. Key Competencies: Capable in attending breakdowns of production machines used in the plant. Capable to read the Engineering drawing i.e Machine layout / P & I diagram. Familiar with the Mechanical sealing of the machines. 0. Educational Qualification and Experience Education : B-Tech Mechanical Engineering Experience : 3-4 Years 5.0. Revision History Version Change Effective Date 1.0 New Document 2020-08-07 2.0 Changed into new template 2023-08-07 6.0. Approval Prepared By: Name: Bhupender Bhardwaj Position: Manager - Engineering Date: 2023-09-27 Checked By: Name: Position: Date: Approved By: Name: Ramesh Pawle Position: VP-Operations Date : Accepted By : Name: Emp. No: Date: Show more Show less
Job Summary : This role to ensure that all sterile medical devices manufactured at the plant meet the highest standards of quality, safety, and compliance. He / She must have strong understanding of regulatory requirements (such as ISO 13485, Indian Medical Device Rule-2017 etc) with respect to inspection & testing, and hands-on experience with quality control processes in a cleanroom or GMP-compliant environment. Key Responsibilities: Supervise the team perform in-process and final inspection of sterile medical devices and components. Conduct sampling, testing, and documentation of raw & packaging materials, finished goods, sales return product, Stability study etc. Involve customer complaint investigation process and prepare necessary investigation reports. Ensure compliance with applicable regulatory standards (ISO 13485,IMDR, MDR etc.). Maintain and calibrate QC instruments and equipment. Prepare and review QC documentation, including SOP's, inspection reports, COA, and deviation reports. Participate in internal audits and support external regulatory inspections. Identify and report non-conformities and assist in root cause analysis and CAPA implementation. Collaborate with production, R&D and QA teams to ensure product quality. Maintain cleanroom protocols and hygiene standards during inspections. Qualifications & Skill Bachelor’s degree in Science, Engineering, Pharmacy, or a related field. 4-6 years of experience in quality control within the medical device industry. Familiarity with GMP, ISO 13485, and IMDR regulations. Proficient in using QC tools and instruments Strong documentation and analytical skills. Good communication and teamwork abilities. Experience with statistical quality control (SQC) and SPC tools. Show more Show less
Are you an Senior Executive - Stores passionate about ensuring that process is completed in a timely and efficient manner? If so, this opportunity could be for you! Join us in Hyderabad at Oyster Medisafe, a pioneer in medical devices, where your skills and experience will be recognized and celebrated. Take the next step in your career with us and help shape the future of healthcare! As an Senior Executive - Stores at B. Braun Group you will play a vital role maintaining efficient production processes for the manufacturing of our high-quality medical products. Your key responsibilities: This includes supervising daily activities, ensuring accuracy in material handling (incoming/outgoing), and managing inventory with a target of 99.99% accuracy. Train subordinates on GMP/SOP, allocate manpower effectively, and foster a culture of safe working practices. Adhere to internal and external audit requirements, aiming for no critical or major findings in the stores area. Collaborate with the purchase department for timely procurement and identify opportunities to reduce consumable/store item costs by 2-5%. Prepare monthly MIS and PPT, ensure timely submission of daily/monthly reports, and continuously upgrade warehouse processes and systems to meet regulatory requirements. Utilize good communication and interpersonal abilities to interact across functions, coupled with strong analytical and problem-solving skills for effective planning and forecasting. What you will bring to the team: 5-6 Years of Experience in Raw Material Stores (Pharma/Medical Equipment) What sets B. Braun apart? Oyster Medisafe Pvt. Ltd., a B. Braun group company in Hyderabad, manufactures CE certified hypodermic syringes, needles and IV sets. Our products are used in hospitals, private practices, and emergency services, establishing us as a key player in the medical device industry. Our core values of Innovation, Efficiency, Sustainability, Trust, Accountability, and Diversity foster a performance-driven culture where we challenge each other constructively to grow personally and professionally. Recognized through awards such as 'Dream Companies to Work For' and 'Great Place to Work,' we invite you to join our team driven by a shared vision - to protect and improve the health of people around the world. What can we offer you? Convenient transport and subsidized canteen services. Mediclaim and Life Insurance. Learning programs and workshops to drive your development. Mental Wellness Support with counselling and mindfulness sessions. Paternity & Birthday Leave for life’s special moments. Fun activities and team building events. What’s next? Upon receiving your application, our dedicated Talent Acquisition team will review your application. If you stand out, you’ll be invited to engage in dynamic interviews, ranging from phone calls to video chats and in-person meetings. Throughout this process, we will keep you informed and inspired with regular updates and feedback. Finally, if you shine through and decide to join us, we will lead you into our seamless onboarding experience. Join us and be part of something extraordinary! We appreciate different perspectives, thoughts, experiences and backgrounds. By strengthening an appreciative, inclusive, respectful and equal working environment, we create a culture in which all our employees feel free to be who they are. To find out more about our commitment to diversity click here Check us out on Social Media! B. Braun Group LinkedIn B. Braun India Facebook B. Braun Group YouTube Show more Show less
Job Responsibilities: Compliance, operation and maintenance of ZLD system. Ensure operational maintenance of New TRO phase 1, Phase 2 & MEE. Ensure operational maintenance of bore well, STP, ETP, PM Analyzer, Piezometers, fire pump room, and rainwater harvesting system and coordinate with maintenance for any required support. Maintain all the compliance of total waste management like biomedical waste, solid hazardous waste, e-waste, plastic waste and used oil. Maintain logbooks of environment related compliances Conduct and monitor of environmental testing i.e. stack monitoring, ambient air, noise monitoring, testing of presser vessel & lifting tools and tackles etc. as per standard. Controlled document processing including change control, training, effectiveness etc. Coordination with Envirolab to full fill the gaps as required. Effectively processing the PR to payment under vendor management Any other activity or project assigned by the Plant Head Key Responsibilities: Purpose & responsibility of this position is to implement and maintain an effective HSE ( Health, Safety & Environment) Management System Support in implementing Occupational health and safety (OHS) management systems, processes and procedures that improve the Occupational Health and Safety of the employees and other interested parties. Support in implementing Environment management systems , processes and procedures to manage environmental aspects & impacts, fulfil compliance obligations, and address risks and opportunities. Responsible for reporting, risk assessments and auditing and observe all HSE related activities and policies Responsible for conducting operations in a safe efficient manner and in conformance to state and central Drug Act and Company Safety regulation and HSE policies and procedures Support in effectively communicating information on the HSE management system throughout the organization and promote HSE awareness Show more Show less
Key Responsibilities Is responsible for record packaging data and maintain accurate production records. Is responsible for maintaining GMP in the department. Train the workmen and operators on work instructions and ensure all the SOPs are followed on the shop floor. Monitor the production process to ensure that packaging is completed in a timely and efficient manner. Periodic training and evaluation of the training effectiveness. Ensure all input materials available in department in time. Ensure machines are in good conditions and outputs are as per quality requirements with regular Preventive Maintenance performances. Inspect and test product packaging for quality and accuracy. Also ensure quality of the products is up to the mark and ensure non-conformities are minimum. Appropriate disciplinary actions for operators who are non-compliant to GDP and GMP Minor changes in machine setting without affecting quality and output. Perform routine maintenance on packaging equipment to ensure it is in good working order. 2.0. KRAs & Specific Roles Appropriate disciplinary actions for operators, who are non-compliant to GDP and GMP. Taking up alternate production plan in case of material shortages. Can take up Kaizen at given point of time. Develop and maintain a safe and clean working environment. 3.0. Key Competencies: OEE improvement Packaging Machines. NQC reduction (MUV-Syringes). Consumable cost reduction. 0. Educational Qualification and Experience Diploma/bachelor’s degree (mechanical/Electrical). 2 to 3 years of related experience. Ability to work non-standard schedule as needed. Show more Show less
Job Summary : This role to ensure that all sterile medical devices manufactured at the plant meet the highest standards of quality, safety, and compliance. He / She must have strong understanding of regulatory requirements (such as ISO 13485, Indian Medical Device Rule-2017 etc) with respect to inspection & testing, and hands-on experience with quality control processes in a cleanroom or GMP-compliant environment. Key Responsibilities: Supervise the team perform in-process and final inspection of sterile medical devices and components. Conduct sampling, testing, and documentation of raw & packaging materials, finished goods, sales return product, Stability study etc. Involve customer complaint investigation process and prepare necessary investigation reports. Ensure compliance with applicable regulatory standards (ISO 13485,IMDR, MDR etc.). Maintain and calibrate QC instruments and equipment. Prepare and review QC documentation, including SOP's, inspection reports, COA, and deviation reports. Participate in internal audits and support external regulatory inspections. Identify and report non-conformities and assist in root cause analysis and CAPA implementation. Collaborate with production, R&D and QA teams to ensure product quality. Maintain cleanroom protocols and hygiene standards during inspections. Qualifications & Skill Bachelor’s degree in Science, Engineering, Pharmacy, or a related field. 4-6 years of experience in quality control within the medical device industry. Familiarity with GMP, ISO 13485, and IMDR regulations. Proficient in using QC tools and instruments Strong documentation and analytical skills. Good communication and teamwork abilities. Experience with statistical quality control (SQC) and SPC tools.
Are you an Executive - Environment Health and Safety passionate about ensuring that process is completed in a timely and efficient manner? If so, this opportunity could be for you! Join us in Hyderabad at Oyster Medisafe, a pioneer in medical devices, where your skills and experience will be recognized and celebrated. Take the next step in your career with us and help shape the future of healthcare! As an Executive - Environment Health and Safety at B. Braun Group you will play a vital role to implement and maintain an effective HSE ( Health, Safety & Environment) Management System. Your key responsibilities: Oversee and maintain environmental treatment systems, including ZLD, TRO, and MEE, ensuring compliance and optimal operation. Manage all aspects of waste management, including biomedical, hazardous, e-waste, plastic, and used oil, ensuring adherence to regulations. Implement and uphold the HSE (Health, Safety & Environment) Management System, including OHS and environmental procedures, risk assessments, and internal audits. Conduct and monitor environmental testing (e.g., stack monitoring, air, noise) and ensure compliance with all environmental regulations and reporting requirements. Maintain comprehensive environmental records and documentation, including logbooks and controlled document processing, and manage related procurement processes. Support and promote a strong HSE culture within the organization, ensuring safe and compliant operations in accordance with relevant acts and company policies. What you will bring to the team: 5-6 Years of Experience and Diploma in Fire Engineering & Safety Management/equivalent qualification. What sets B. Braun apart? Oyster Medisafe Pvt. Ltd., a B. Braun group company in Hyderabad, manufactures CE certified hypodermic syringes, needles and IV sets. Our products are used in hospitals, private practices, and emergency services, establishing us as a key player in the medical device industry. Our core values of Innovation, Efficiency, Sustainability, Trust, Accountability, and Diversity foster a performance-driven culture where we challenge each other constructively to grow personally and professionally. Recognized through awards such as 'Dream Companies to Work For' and 'Great Place to Work,' we invite you to join our team driven by a shared vision - to protect and improve the health of people around the world. What can we offer you? Convenient transport and subsidized canteen services. Mediclaim and Life Insurance. Learning programs and workshops to drive your development. Mental Wellness Support with counselling and mindfulness sessions. Paternity & Birthday Leave for life’s special moments. Fun activities and team building events. What’s next? Upon receiving your application, our dedicated Talent Acquisition team will review your application. If you stand out, you’ll be invited to engage in dynamic interviews, ranging from phone calls to video chats and in-person meetings. Throughout this process, we will keep you informed and inspired with regular updates and feedback. Finally, if you shine through and decide to join us, we will lead you into our seamless onboarding experience. Join us and be part of something extraordinary! We appreciate different perspectives, thoughts, experiences and backgrounds. By strengthening an appreciative, inclusive, respectful and equal working environment, we create a culture in which all our employees feel free to be who they are. To find out more about our commitment to diversity click here Check us out on Social Media! B. Braun Group LinkedIn B. Braun India Facebook B. Braun Group YouTube
JD Number : JD/OYS/QM/002 (Officer QC - Testing) Position : Officer – QC Job Description : The primary responsibility of the Inprocess Quality Inspector is to ensure that all products meet the required quality standards throughout the manufacturing process. Key Responsibilities: Perform visual and dimensional inspections of medical devices at various stages of the manufacturing process. Perform testing on components, Raw Material, Packaging Material, Inprocess Products and Finished Products . Conduct in-process quality inspections to verify product specifications and compliance. Document and report any deviations or non-conformances found during inspections. Work closely with production and engineering teams to address quality issues and implement corrective actions. Participate in Investigation of In-house reworks and Customer Complaints Conduct routine calibration and maintenance of inspection equipment. Assist in verifying and updating work instructions and quality control procedures. Provide training and support to production operators on quality standards and inspection processes. Maintain accurate records and documentation of quality inspection results. Participate in quality improvement initiatives and continuous process improvement projects. Adhere to all safety and quality regulations and guidelines. Responsible for ensuring adherence of Personal Hygiene of Operators in Production area. Comply with B. Braun code of conduct as well as compliance procedures Qualifications: Diploma or degree in science or equivalent with 0-2 years experience. Capability in using measurement tools and equipment for quality inspections. Strong attention to detail and accuracy. Ability to work independently and collaboratively in a fast-paced environment. Able to work in clean room condition.
Job Responsibilities: Responsible for Microbiological activities in the plant with respect to testing of all applicable products and Environmental monitoring of clean room / classified room. Responsible for microbiological sample receiving/ labelling/ preparation/ sampling/ test/ counting/ checking and recording of data analysis on finished products, stability test samples and any other test requisitions as directed by the superior. Support continuous compliance to all required Microbiological requirements with respects to ISO, CE, India FDA etc. Maintenance of Good House Keeping, Safety and Correct use of Micro lab equipments. Maintenance of microbiological testing material / culture stock and records. Supporting the superior in achieving objectives/ targets outlined by the Head of Department. Liaisons with external laboratory for test related to Microbiology Comply with B. Braun code of conduct as well as compliance procedures. Key Responsibilities: To ensure timely microbiological testing and release of product as per specification. To ensure Testing of finished products as per Specification and approve / reject the finished goods and forward all batch reports to QA for authorisation. Conduct bioburden / Sterility / Bacterial Endotoxin test for the products as per specification. Perform Clean room monitoring as per applicable ISO requirement. Monitoring GMP of entire plant with respect to hygiene. Maintenance of Quality Records Stock control samples and records. Maintenance of good housekeeping ,safety and correct use of equipment in the department. To coordinate the purchase of media, reagents and other types of consumables and to ensure availability in inventory. To coordinate and sourcing and repair laboratory test equipment. To support the superior in the preparation of test methods/ specification/ procedures and equipment operating instructions. To participate in process and test methods/ specification/ procedures and equipment operating instructions. To ensure timely submission/ release of test results/ reports. Works under general supervision. Relies on knowledge and moderate experience to accomplish assigned goals and report on results and accomplishments. Competencies for the role: Requires a basic knowledge of microbiology field and mastery of skills in microbiology testing area. Apply procedures/ techniques/ tools/ materials to execute tasks /responsibilities Judgment is required in resolving simple to moderately complex problems. should have good communication & inter-personnel skills to interact with various functions to co-ordinate the activities. Should have the skills on learning & applying, customer orientation and be able to work in teams. Educational Qualification & Experience: Graduation in Microbiology / Biotechnology Minimum 0-2 years of experience in Microbiology lab
Job Summary : This role to ensure that all sterile medical devices manufactured at the plant meet the highest standards of quality, safety, and compliance. He / She must have strong understanding of regulatory requirements (such as ISO 13485, Indian Medical Device Rule-2017 etc) with respect to inspection & testing, and hands-on experience with quality control processes in a cleanroom or GMP-compliant environment. Key Responsibilities: Supervise the team perform in-process and final inspection of sterile medical devices and components. Conduct sampling, testing, and documentation of raw & packaging materials, finished goods, sales return product, Stability study etc. Involve customer complaint investigation process and prepare necessary investigation reports. Ensure compliance with applicable regulatory standards (ISO 13485,IMDR, MDR etc.). Maintain and calibrate QC instruments and equipment. Prepare and review QC documentation, including SOP&aposs, inspection reports, COA, and deviation reports. Participate in internal audits and support external regulatory inspections. Identify and report non-conformities and assist in root cause analysis and CAPA implementation. Collaborate with production, R&D and QA teams to ensure product quality. Maintain cleanroom protocols and hygiene standards during inspections. Qualifications & Skill Bachelors degree in Science, Engineering, Pharmacy, or a related field. 4-6 years of experience in quality control within the medical device industry. Familiarity with GMP, ISO 13485, and IMDR regulations. Proficient in using QC tools and instruments Strong documentation and analytical skills. Good communication and teamwork abilities. Experience with statistical quality control (SQC) and SPC tools. Show more Show less
Are you an Senior Executive - Stores passionate about ensuring that process is completed in a timely and efficient manner? If so, this opportunity could be for you! Join us in Hyderabad at Oyster Medisafe, a pioneer in medical devices, where your skills and experience will be recognized and celebrated. Take the next step in your career with us and help shape the future of healthcare! As an Senior Executive - Stores at B. Braun Group you will play a vital role maintaining efficient production processes for the manufacturing of our high-quality medical products. Your key responsibilities: This includes supervising daily activities, ensuring accuracy in material handling (incoming/outgoing), and managing inventory with a target of 99.99% accuracy. Train subordinates on GMP/SOP, allocate manpower effectively, and foster a culture of safe working practices. Adhere to internal and external audit requirements, aiming for no critical or major findings in the stores area. Collaborate with the purchase department for timely procurement and identify opportunities to reduce consumable/store item costs by 2-5%. Prepare monthly MIS and PPT, ensure timely submission of daily/monthly reports, and continuously upgrade warehouse processes and systems to meet regulatory requirements. Utilize good communication and interpersonal abilities to interact across functions, coupled with strong analytical and problem-solving skills for effective planning and forecasting. What you will bring to the team: 5-6 Years of Experience in Raw Material Stores (Pharma/Medical Equipment) What sets B. Braun apart? Oyster Medisafe Pvt. Ltd., a B. Braun group company in Hyderabad, manufactures CE certified hypodermic syringes, needles and IV sets. Our products are used in hospitals, private practices, and emergency services, establishing us as a key player in the medical device industry. Our core values of Innovation, Efficiency, Sustainability, Trust, Accountability, and Diversity foster a performance-driven culture where we challenge each other constructively to grow personally and professionally. Recognized through awards such as 'Dream Companies to Work For' and 'Great Place to Work,' we invite you to join our team driven by a shared vision - to protect and improve the health of people around the world. What can we offer you? Convenient transport and subsidized canteen services. Mediclaim and Life Insurance. Learning programs and workshops to drive your development. Mental Wellness Support with counselling and mindfulness sessions. Paternity & Birthday Leave for life’s special moments. Fun activities and team building events. What’s next? Upon receiving your application, our dedicated Talent Acquisition team will review your application. If you stand out, you’ll be invited to engage in dynamic interviews, ranging from phone calls to video chats and in-person meetings. Throughout this process, we will keep you informed and inspired with regular updates and feedback. Finally, if you shine through and decide to join us, we will lead you into our seamless onboarding experience. Join us and be part of something extraordinary! We appreciate different perspectives, thoughts, experiences and backgrounds. By strengthening an appreciative, inclusive, respectful and equal working environment, we create a culture in which all our employees feel free to be who they are. To find out more about our commitment to diversity click here Check us out on Social Media! B. Braun Group LinkedIn B. Braun India Facebook B. Braun Group YouTube
Key Responsibilities Run the Machine as per given procedure (strictly follow the SOP’s). To ensure Department MPS is planned and achieved for the month. And maintain output as per Line efficiency of the machine. EHS rules need to be strictly followed. Reduce the break downs in all machines. To maintain hygiene and cleaning in department. 2.0. KRAs & Specific Roles Maintain OEE of the department as the targets given. Achieving daily output as per defined line efficiency of each machine. Ensure all Preventive Maintenance of machines are conducted as planned. To attend the machine breakdowns and inform to relevant department and trying to solve the breakdown and minimize breakdowns. Faster Trouble shooting, maintain quality and maximum output. If any changes, write change controls and document the data. . Daily manage SAP management. Ensure all orders are TECO closed. Ensure all sap activities are done without errors. Ensure physical and sap stocks match every month by organizing stock check internally and check sap bookings are done correctly. Also need to take follow-up of non-moving stock from quarantine area. Ensure Validations of new machines and meet the URS requirements. Ensure cleanliness in Sterilization department. Execute and living the B/Braun Code of Conduct. Ensure and implement GMP and GDP in Sterilization department. Maintenance of documents for ISO and CE for audits. Ensure all sops are followed and all mentioned forms and documents are updated. Provide production and SOP relevant training to operators and line leaders. Ensure training plan is prepared and executed efficiently. Every month report to HR regarding trainings completion and document them. To prepare URS, FAT and SAT reports for all new machines. And validate all new machines as per the global sops. 3.0. Key Competencies: Work experience preferably in Sterilization Process. 0. Educational Qualification and Experience Diploma or B.E in mechanical Engineering. 2 to 3 years of related experience.
Job Summary: This position will be responsible for ensuring that all products and processes comply with regulatory standards and internal quality policies. Also responsible for managing documentation, handling deviations and change control, overseeing validation processes, ensuring data integrity, driving continuous improvement, managing Corrective and Preventive Actions (CAPA), and conducting internal audits. Key Responsibilities: Documentation Management Act as author, maintaining and managing quality documentation in digital B. Braun Document and collaboration system. Maintain and update quality assurance documentation, including Standard Operating Procedures (SOPs) and forms. Deviation Management and Change Control Identify, document, and investigate deviations from standard processes. Perform root cause analysis and implement corrective actions to prevent recurrence. Ensure timely closure of deviation reports and maintain records for audit purposes. Involve in change control activities and co-ordinate from QM perspective. Validation Develop and execute validation protocols for equipment, processes, and software. Ensure validation activities comply with regulatory standards and industry best practices. Maintain validation documentation and ensure it is readily available for audits. Responsible for Sterilization validation. Data Integrity Ensure the accuracy, consistency, and reliability of data throughout the manufacturing process. Implement and monitor data integrity policies and procedures. Conduct regular audits to verify data integrity and address any discrepancies. Corrective and Preventive Actions (CAPA) Manage the CAPA process, including the identification, investigation, and resolution of quality issues. Develop and implement CAPA plans to address root causes and prevent recurrence. Track and report on the status of CAPA activities to ensure timely completion in digital B.TraQS system. Internal Audits: Involve and co-ordinate internal audits to assess compliance with quality standards and regulatory requirements. Assist in preparing audit reports and communicate findings to relevant stakeholders. Follow up on audit findings to ensure corrective actions are implemented and effective. Job Requirements: Education: Bachelor's degree in a relevant field (e.g., Bio Engineering, Life Sciences, Engineering, Quality Management). Experience: Minimum of 5 years of experience in quality relevant in manufacturing , preferably in the medical device or pharmaceutical industry. Certifications: Preferrable to have internal auditor certification in ISO 13485 & awareness on Indian Medical Device Rule and EU Medical Device Regulations. Knowledge: Preferrable to have knowledge in standards, including ISO 13485, CE marking, EU MDR 2017/745 and Indian Medical Device Rules & regulations. Skills: Excellent document management and system handling skills. Strong communication and interpersonal skills. Attention to Detail: High level of accuracy and attention to detail in all tasks.
Inspecting, testing, and updating electronic systems, components, equipment, and software. Ensuring all equipment and products meet health and safety regulations. Observing existing processes and making recommendations for improvement. Developing effective maintenance, testing, and quality control procedures. Showing initiative and keeping up with advancements in Electronics. Monitoring processes, systems, and staff, and punctually identifying problems. Writing specifications, instructions, reports, and handling other required administrative duties. Directing maintenance activities on utility systems to provide continues supply of Electricity, Air & water. Carrying out analyze and troubleshoot complex electrical problems. Providing technical support to customers and other internal team members. Preventive maintenance of production & utility equipments as per schedule. Must follow all safety procedures required in production department and ensure same are adhered by his team/subordinates. Identification & resolving of breakdown in timely manner. Must be able to read engineering drawings and machine manuals and interpret information properly. Should be able to undertake any other tasks directed by management KRA & specific role. Ensure all GMP/FDA/ISO regulations and procedures are followed while maintenance of all equipments