8 Ebmr Jobs

As an experienced professional in the field of Quality Management Systems (QMS), you will be responsible for various key activities including handling of Corrective and Preventive Actions (CCF), Deviations, Out of Specification (OOS) incidents, and more. Your role will involve the preparation and thorough review of Standard Operating Procedures (SOPs), Equipment Operating Procedures (EOPs), Operational Control Plans (OCPs), Batch Manufacturing Records (BMR), and other crucial production documents. In addition, you will play a significant part in reviewing batch reports, identifying opportunities for productivity enhancements, and conducting investigations into batch failures. Your expertise will be instrumental in the development of critical documents such as the Accident and Incident Management (AIM) register and Hazard Identification and Risk Assessment (HIRA) register. Furthermore, you will be involved in conducting Hazard and Operability (HAZOP) studies to ensure a comprehensive approach to risk management. Collaboration will be a key aspect of your role as you will work closely with the Quality Assurance (QA) team to facilitate validation, qualification, and audit readiness activities. Adherence to established Standard Operating Procedures (SOPs), product specifications, Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP) will be paramount to ensure compliance and quality standards are consistently met. Your responsibilities will also encompass the meticulous review of all completed documents to verify their accuracy, completeness, and proper authorization. Real-time data entry into Quality records and proficiency in handling electronic Batch Manufacturing Records (e-BMR) through systems like SAP will be essential to maintain efficient operations. A solid understanding of Automation systems such as Distributed Control Systems (DCS), Manufacturing Execution Systems (MES), and Energy Management Systems (EMS) will further enhance your ability to streamline processes and drive operational excellence. If you possess a BSc or MSc qualification along with a proven track record of 8 to 10 years in a similar role, and if you are looking to make a significant impact in a dynamic work environment, we invite you to consider this opportunity to contribute your expertise and drive continuous improvement in our organization.,

An eBMR/MFG domain expert with specialized knowledge and experience in electronic batch manufacturing records (eBMR) and manufacturing (MFG) processes, particularly in industries like pharmaceuticals, biotechnology, and life sciences. These experts can provide valuable insights into the implementation, optimization, and compliance aspects of eBMR systems within a manufacturing context Key aspects of an eBMR/MFG domain experts expertise include -Understanding of batch manufacturing processes -Knowledge of eBMR systems and their functionalities -Ability to identify and resolve issues -Collaboration and communication skills -Improve data accuracy and traceability -Enhance process efficiency -Designing and implementing eBMR systems -Training personnel on using the eBMR system -Developing and maintaining eBMR documentation

An eBMR/MFG domain expert with specialized knowledge and experience in electronic batch manufacturing records (eBMR) and manufacturing (MFG) processes, particularly in industries like pharmaceuticals, biotechnology, and life sciences. These experts can provide valuable insights into the implementation, optimization, and compliance aspects of eBMR systems within a manufacturing context Key aspects of an eBMR/MFG domain experts expertise include -Understanding of batch manufacturing processes -Knowledge of eBMR systems and their functionalities -Ability to identify and resolve issues -Collaboration and communication skills -Improve data accuracy and traceability -Enhance process efficiency -Designing and implementing eBMR systems -Training personnel on using the eBMR system -Developing and maintaining eBMR documentation

An eBMR/MFG domain expert with specialized knowledge and experience in electronic batch manufacturing records (eBMR) and manufacturing (MFG) processes, particularly in industries like pharmaceuticals, biotechnology, and life sciences. These experts can provide valuable insights into the implementation, optimization, and compliance aspects of eBMR systems within a manufacturing context Key aspects of an eBMR/MFG domain experts expertise include -Understanding of batch manufacturing processes -Knowledge of eBMR systems and their functionalities -Ability to identify and resolve issues -Collaboration and communication skills -Improve data accuracy and traceability -Enhance process efficiency -Designing and implementing eBMR systems -Training personnel on using the eBMR system -Developing and maintaining eBMR documentation

You will be responsible for handling production equipment including vial washing & Depyrogenation tunnel, Autoclave, Manufacturing, Steam air sterilizer, Laundry area, Vial coding (Domino), and external vial washing. Additionally, you will be in charge of the requalification/qualification of equipment such as autoclave, vial washing, and tunnel. Your duties will also include managing the auto CIP & SIP process of manufacturing tanks, as well as having knowledge about audit trails and data backup. Familiarity with computer systems like eBMR, PLC, and SCADA will be essential for this role. Furthermore, you should possess knowledge about change control, regulatory affairs, corrective and preventive actions (CAPA), and environment, health, and safety (EHS) activities. The ideal candidate will have a Bachelor's or Master's degree in Pharmacy, along with 4 to 8 years of experience in the field. Previous experience at Zydus for 12 to 24 months is preferred. This position is based in the Production Department at Zydus Pfizer in Ahmedabad.,

Hi, We are having an opening for Manager IT - MES SME at our Halol or Baska(Gujarat) location. Job Summary : We are seeking a seasoned professional with 6-8 years of experience in the pharmaceutical industry, including technical and functional experience in MES & L2 systems. The Site SME MES Project is a key functional and technical expert responsible for supporting the successful implementation of the Manufacturing Execution System (MES) & L2 at the Halol & Baska pharmaceutical manufacturing sites. This role ensures that site-specific manufacturing processes are accurately captured and reflected in the global MES solution. The SME is also accountable for leading site-level validation activities and technical owner responsibility , and managing all GxP documentation related to the MES & L2 system. The Site SME is the go-to authority for end-to-end MES product knowledge. This includes a deep understanding of system functionality, configuration, and compliance requirements.The SME also serves as the first point of contact for any MES front-end application issues, supporting users in troubleshooting, training, and ongoing system usage post-go-live. The ideal candidate will ensure adherence to global regulations (FDA 21 CFR Part 11, EU GMP, GAMP5) Previous experience with Werum (Korber Pharma) for pharma industry is a big plus Areas Of Responsibility : MES Implementation: Representing site-specific needs during MES design, configuration, and deployment. Validation Leadership: Leading IQ, OQ, PQ, UAT, and traceability matrix execution. Documentation Ownership: Managing GxP documentation (URS, FS, DS, test cases, validation plans/reports). MES Product Expertise: Maintaining deep knowledge of MES functionality and architecture. Front-End Support: Acting as the first point of contact for MES application issues and user support. Training & Adoption: Delivering training and ensuring user readiness for MES usage. Data Management: Supporting data collection, migration, and master recipe creation. Audit Readiness: Ensuring all documentation and systems are compliant and audit-ready. Educational Qualification : Bachelors degree in Engineering - Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field. Preferred: Masters degree (e.g., MBA, M.Tech, M.Pharm) with specialization in Industrial Automation, Pharmaceutical Technology or related technical fields Specific Certification : GAMP 5 for system validation in regulated environments. CSV (Computer System Validation) for compliance with GxP. MES Platform Certifications e.g., Werum PAS-X, Siemens Opcenter, or Rockwell 21 CFR Part 11 Compliance Training for electronic records and signatures Experience : 6 to 8 years of experience Pharmaceutical Manufacturing: Strong understanding of pharma shop floor operations and regulatory requirements. MES or Digital Systems: Prior hands-on experience with MES platforms or similar systems in GxP-regulated environments. Validation Expertise: Proven experience in validation documentation and execution, especially for GxP Category 4 & 5 systems. Application Support: Experience in resolving front-end MES issues and supporting end-users post-deployment. Audit Experience: Familiarity with audit processes and documentation expectations Skill (Functional & Behavioural): Functional: MES system configuration, deployment, and validation, Front-end application troubleshooting and user support, GxP and 21 CFR Part 11 compliance, Validation protocol development and execution (IQ, OQ, PQ, UAT), Documentation management (URS, FS, DS, traceability matrices), Data migration and master recipe creation Behavioral: Strong communication and interpersonal skills, Proactive problem-solving and risk management, High attention to detail and compliance mindset, Ability to work under pressure and manage multiple priorities, Detail- oriented with a focus on compliance and quality, Proactive problem-solving and decision-making, Comfortable working on the shop floor and in technical environments Additional Skills: (Good to have) Knowledge of data analytics tools Edge Cloud deployment experience with (IoT and and IIoT) L2 integration with MES MES integration with SAP Understanding of network and databases

Role & responsibilities Lead and manage both the MES team and the Automation team, ensuring efficient project execution and alignment with organizational goals. Drive PAS-X MES implementation projects across various phases including design, development, testing, and deployment and Maintenance. Oversee integration of PAS-X MES with shop floor equipment & ERP, ensuring seamless data exchange and operational efficiency. Manage Level 2 integration efforts with shop floor equipment, focusing on systems like GE iFix SCADA, Kepware OPC, Siemens PLC, and SCADA systems. Directly engage in PLC and SCADA programming, troubleshooting, and equipment maintenance activities. Maintain PAS-X MES recipes and recipe authoring processes in collaboration with relevant stakeholders. Provide technical leadership and guidance to team members, encourage a culture of continuous improvement and technical excellence. Collaborate with cross-functional teams including IT, engineering, operations, and quality assurance to ensure successful project outcomes. Skill & Qualifications: Minimum of 6 years of experience in PAS|x MES implementation within the pharmaceutical industry and over all Min 10 years of experience in pharmaceutical Industry. Proven experience in integrating MES with shop floor equipment & ERP, particularly with Level 2 systems and SAP. Proficiency in GE iFix SCADA, Kepware OPC, Siemens PLC, and other relevant automation/ Historian technologies. Hands-on experience in PLC and SCADA programming, configuration, and troubleshooting. Strong understanding of equipment maintenance practices and methodologies. Experience in MES recipe authoring and managing recipe lifecycles. Strong analytical and problem-solving abilities, with a keen attention to detail. Bachelors degree in engineering Instrumentation/Computer Science, or related field. Familiarity with regulatory requirements and standards in the pharmaceutical industry (e.g., GMP, FDA regulations). Preferred candidate profile Candidate should have experience in biotech industry

Walk-in interview @ Ahmedabad For Sun Pharmaceutical Industries Limited, Dadra Date: 15th Jun 25 (Sunday) We are recruiting for our OSD manufacturing facility located at Dadra Time: 10 AM to 4 PM Interview Venue: The Fern Residency, Ahmedabad Near Subhash Bridge Corner, RTO Circle Ahmedabad Gujarat 380027. India Following are the requirements for our manufacturing facility at Dadra Location. 1) Designation: Officer / Sr. Officer Manufacturing & Packing Education: B. Pharm / M. Pharm Department: OSD Manufacturing & Packing Experience: 2- 6 years of experience in OSD manufacturing handling Granulation, Compression, Tablet Coating, Tablet Inspection, and Bottle Packing activities in an OSD manufacturing plant, should have knowledge of cGMP. 2) Designation: Technician Manufacturing & Packing Education: ITI / Diploma/ B. Sc Department: OSD Manufacturing & Packing Experience: 4 - 8 years of work experience in pharmaceutical company, handling Granulation, Compression, Tablet Coating, Tablet Inspection and Bottle Packing activities in a regulated manufacturing plant. For all the positions, we are looking for candidates with experience in regulated plants like USFDA, MHRA, ANVISA, TGA etc. Interested candidates meeting with criteria should carry their updated resume along with photograph, Photocopy of Salary Supporting/Appointment/latest Increment letters giving salary breakups of Monthly & Annual Salary is must. Those who are unable to attend the personal interview may send their resume by e-mail to rupeshkumar.upadhyay@sunpharma.com