Long Description Person able to handle routuine area and equipment cleaning activities in claissified area. Person able to handle steam sterilizer operation. Person shall maintain the area as per GMP requirement. Person is able to perform the pooling and mixing, filling and other batch activities. person is able to perform cleaning of accesoires which are use for production batch. Competencies Education Graduation in Chemistry or Pharmacy Work Experience Fresher
Job Description Vendor Management : Identify and evaluate potential suppliers through market research and networking. Negotiate pricing, payment terms, and delivery schedules. Maintain strong relationships with vendors to ensure long-term collaboration.. Procurement Operations Create and process purchase orders in compliance with company policies. Track and manage deliveries to ensure timely receipt of goods. Review and verify invoices against purchase orders and delivery notes. Compliance - Ensure adherence to company procurement policies and regulations. Reporting & Coordination Prepare procurement reports and maintain accurate records. Coordinate with internal stakeholders to understand purchasing needs. Work Experience 3–5 years of experience in procurement or purchasing. Education Graduation Post Graduation in Biochemistry Competencies
As a Manufacturing Process Support Lead, you will be responsible for various tasks including but not limited to: - Leading the upstream manufacturing process support, data acquisition, and trending. - Managing statistical analysis of manufacturing batches data using statistical software like Minitab, etc. - Leading the upstream team in troubleshooting and process related deviation investigations activities to identify the root cause followed by providing an effective CAPA. - Planning, evaluating and managing the technology transfer of new / existing products from sending unit (R&D) to receiving unit (Manufacturing). - Collaborating and communicating regularly with R&D teams in execution of experimental runs and any other scale down experiments to support manufacturing process changes/improvements. - Planning and successfully implementing process changes in upstream manufacturing processes with relevant CFT consensus. - Conducting risk assessment, validation protocols, validation reports and facility fit assessment applicable for upstream processes. - Reviewing technical documents i.e. manufacturing batch records, SOPs, study protocols, study reports and cleaning validation documents etc. - Coaching, mentoring and training upstream team members in skill development. **Qualifications required:** - Masters in Biotechnology or Pharmaceutical Technology - Doctorate in Biotechnology or Pharmaceutical Technology If there are any additional details about the company in the job description, please provide them for a comprehensive understanding of the role. As a Manufacturing Process Support Lead, you will be responsible for various tasks including but not limited to: - Leading the upstream manufacturing process support, data acquisition, and trending. - Managing statistical analysis of manufacturing batches data using statistical software like Minitab, etc. - Leading the upstream team in troubleshooting and process related deviation investigations activities to identify the root cause followed by providing an effective CAPA. - Planning, evaluating and managing the technology transfer of new / existing products from sending unit (R&D) to receiving unit (Manufacturing). - Collaborating and communicating regularly with R&D teams in execution of experimental runs and any other scale down experiments to support manufacturing process changes/improvements. - Planning and successfully implementing process changes in upstream manufacturing processes with relevant CFT consensus. - Conducting risk assessment, validation protocols, validation reports and facility fit assessment applicable for upstream processes. - Reviewing technical documents i.e. manufacturing batch records, SOPs, study protocols, study reports and cleaning validation documents etc. - Coaching, mentoring and training upstream team members in skill development. **Qualifications required:** - Masters in Biotechnology or Pharmaceutical Technology - Doctorate in Biotechnology or Pharmaceutical Technology If there are any additional details about the company in the job description, please provide them for a comprehensive understanding of the role.
Role Overview: You will be responsible for ensuring the readiness of equipment and instruments for the manufacturing process. Additionally, you will ensure the availability of process raw materials, accessories, and consumables in the process area before batch execution. Your role will also involve the preparation, review, and execution of various protocols and reports related to process, equipment, area qualification, and validation. Key Responsibilities: - Prepare and review process, equipment, and area related Standard Operating Procedures (SOPs) and Emergency Operating Procedures (EOPs). - Execute process, area, and equipment qualification/validation protocols. - Prepare various reports such as process, equipment, and area qualification and validation reports. - Prepare, review, and execute Batch Production Records (BPR) and handle their request and issuance. - Prepare, review, and execute study protocols. - Ensure the readiness of downstream areas and other manufacturing areas for operations. - Ensure smooth functioning of shop floor functions during manufacturing campaigns. - Raise and review change control and deviations as required. - Handle SAP related activities pertaining to process and maintenance. - Operate downstream equipment for the manufacturing process and Cleaning-in-Place/Sterilization-in-Place (CIP/SIP) processes. Qualifications Required: - M.Sc. or B.Tech with a post-graduation degree. - B.Tech in Biotechnology or Biochemistry. - 11 to 16 years of experience in biosimilar manufacturing, production planning, and Quality Management Systems (QMS). (Note: Additional details about the company were not included in the provided job description.) Role Overview: You will be responsible for ensuring the readiness of equipment and instruments for the manufacturing process. Additionally, you will ensure the availability of process raw materials, accessories, and consumables in the process area before batch execution. Your role will also involve the preparation, review, and execution of various protocols and reports related to process, equipment, area qualification, and validation. Key Responsibilities: - Prepare and review process, equipment, and area related Standard Operating Procedures (SOPs) and Emergency Operating Procedures (EOPs). - Execute process, area, and equipment qualification/validation protocols. - Prepare various reports such as process, equipment, and area qualification and validation reports. - Prepare, review, and execute Batch Production Records (BPR) and handle their request and issuance. - Prepare, review, and execute study protocols. - Ensure the readiness of downstream areas and other manufacturing areas for operations. - Ensure smooth functioning of shop floor functions during manufacturing campaigns. - Raise and review change control and deviations as required. - Handle SAP related activities pertaining to process and maintenance. - Operate downstream equipment for the manufacturing process and Cleaning-in-Place/Sterilization-in-Place (CIP/SIP) processes. Qualifications Required: - M.Sc. or B.Tech with a post-graduation degree. - B.Tech in Biotechnology or Biochemistry. - 11 to 16 years of experience in biosimilar manufacturing, production planning, and Quality Management Systems (QMS). (Note: Additional details about the company were not included in the provided job description.)
As a Field Force Training Manager, your role involves collating training requirements identified through needs analysis and formulating a comprehensive training framework, plan, and roadmap for different levels (MEs & AMs). Your key responsibilities include: - Organizing and delivering interactive and timely training programs for the field force - Collaborating with the Business unit to develop product refresh training, handling objections, and presentations for brand/indication launches - Reinforcing skills application through field activities, coaching, team role-play, and presentations - Providing in-field training support for the Sales team aligned with Organizational priorities - Running annual field force skills and knowledge assessments, generating insight reports, and implementing remedial actions through Digital tools (SMART WINNR) - Developing internal team members through structured Individual Development Plans (IDPs) You are expected to demonstrate competencies in: - Innovation & Creativity - Process Excellence - Collaboration - Customer Centricity - Developing Talent - Strategic Agility - Stakeholder Management - Result Orientation The qualifications required for this role are: - Post Graduation in Business Management - Graduation in Pharmacy Ideally, you should have a minimum of 5-10 years of experience in Pharma Sales Training. As a Field Force Training Manager, your role involves collating training requirements identified through needs analysis and formulating a comprehensive training framework, plan, and roadmap for different levels (MEs & AMs). Your key responsibilities include: - Organizing and delivering interactive and timely training programs for the field force - Collaborating with the Business unit to develop product refresh training, handling objections, and presentations for brand/indication launches - Reinforcing skills application through field activities, coaching, team role-play, and presentations - Providing in-field training support for the Sales team aligned with Organizational priorities - Running annual field force skills and knowledge assessments, generating insight reports, and implementing remedial actions through Digital tools (SMART WINNR) - Developing internal team members through structured Individual Development Plans (IDPs) You are expected to demonstrate competencies in: - Innovation & Creativity - Process Excellence - Collaboration - Customer Centricity - Developing Talent - Strategic Agility - Stakeholder Management - Result Orientation The qualifications required for this role are: - Post Graduation in Business Management - Graduation in Pharmacy Ideally, you should have a minimum of 5-10 years of experience in Pharma Sales Training.
As a Medical Safety Expert, your role involves performing medical review of safety reports, triage activities, and signal management activities. You will be responsible for signal detection, validation, prioritization, and assessment, as well as proposing recommendations. Additionally, you will conduct safety evaluation of ongoing signals, safety issues, IRSR, etc. Your tasks will also include reviewing non-ICSR scientific literature from a signal and aggregate report perspective. Key Responsibilities: - Provide safety concerns, search criteria, and literature review for aggregate reports - Conduct medical evaluation of aggregate reports (PSUR, PBRER, PADER, ASR etc.) and analyze the benefit-risk balance of the product - Support the safety writing team with medical expertise - Review Risk Management Plan and participate in risk mitigation activities - Review and approve Individual Case Safety Reports - Provide MedDRA coding - Perform Medical Safety Expert Assessment for regulatory requests - Review safety alerts from regulatory authorities Qualifications Required: - Physician-MBBS/MD professional with a minimum of 5 years of experience in medical review of ICSR - Minimum 2-3 years of experience in signal detection or medical review of safety reports or Risk Management Plan - Proficient in assessing causality, seriousness, labelling, and use of SMQs In this role, you are expected to possess competencies in Developing Talent, Result Orientation, Customer Centricity, Strategic Agility, Process Excellence, Innovation & Creativity, Stakeholder Management, and Collaboration. As a Medical Safety Expert, your role involves performing medical review of safety reports, triage activities, and signal management activities. You will be responsible for signal detection, validation, prioritization, and assessment, as well as proposing recommendations. Additionally, you will conduct safety evaluation of ongoing signals, safety issues, IRSR, etc. Your tasks will also include reviewing non-ICSR scientific literature from a signal and aggregate report perspective. Key Responsibilities: - Provide safety concerns, search criteria, and literature review for aggregate reports - Conduct medical evaluation of aggregate reports (PSUR, PBRER, PADER, ASR etc.) and analyze the benefit-risk balance of the product - Support the safety writing team with medical expertise - Review Risk Management Plan and participate in risk mitigation activities - Review and approve Individual Case Safety Reports - Provide MedDRA coding - Perform Medical Safety Expert Assessment for regulatory requests - Review safety alerts from regulatory authorities Qualifications Required: - Physician-MBBS/MD professional with a minimum of 5 years of experience in medical review of ICSR - Minimum 2-3 years of experience in signal detection or medical review of safety reports or Risk Management Plan - Proficient in assessing causality, seriousness, labelling, and use of SMQs In this role, you are expected to possess competencies in Developing Talent, Result Orientation, Customer Centricity, Strategic Agility, Process Excellence, Innovation & Creativity, Stakeholder Management, and Collaboration.
As a Regulatory Affairs Specialist, you will be responsible for leading regulatory submissions for Inhalation, Nasal, Oral Solid Dosage (OSD), Contract Manufacturing, and Strategic Alliance projects for the US market. Your role will involve ensuring timely and compliant responses to product deficiencies raised by US regulatory authorities, including the USFDA. Additionally, you will manage post-approval submissions and annual reports for USFDA-approved products to ensure continuous regulatory compliance and lifecycle management. Key Responsibilities: - Drive labeling updates in alignment with changes to Reference Listed Drug (RLD) labeling approved by the USFDA. - Provide regulatory support for PADER (Periodic Adverse Drug Experience Reports) to contribute to global pharmacovigilance and safety monitoring. - Review and offer strategic input on documentation throughout product development, scale-up, and commercial manufacturing stages. - Oversee document reviews for externally manufactured products to ensure regulatory consistency and quality standards. Qualifications Required: - 1 to 2 years of experience in Regulatory Affairs for Regulated Markets. - Graduation in Pharmacy. - Masters in Science. In this role, you will be expected to demonstrate competencies such as Customer Centricity, Developing Talent, Collaboration, Strategic Agility, Process Excellence, Stakeholder Management, Innovation & Creativity, and Result Orientation. Please note that the company's additional details were not provided in the job description. As a Regulatory Affairs Specialist, you will be responsible for leading regulatory submissions for Inhalation, Nasal, Oral Solid Dosage (OSD), Contract Manufacturing, and Strategic Alliance projects for the US market. Your role will involve ensuring timely and compliant responses to product deficiencies raised by US regulatory authorities, including the USFDA. Additionally, you will manage post-approval submissions and annual reports for USFDA-approved products to ensure continuous regulatory compliance and lifecycle management. Key Responsibilities: - Drive labeling updates in alignment with changes to Reference Listed Drug (RLD) labeling approved by the USFDA. - Provide regulatory support for PADER (Periodic Adverse Drug Experience Reports) to contribute to global pharmacovigilance and safety monitoring. - Review and offer strategic input on documentation throughout product development, scale-up, and commercial manufacturing stages. - Oversee document reviews for externally manufactured products to ensure regulatory consistency and quality standards. Qualifications Required: - 1 to 2 years of experience in Regulatory Affairs for Regulated Markets. - Graduation in Pharmacy. - Masters in Science. In this role, you will be expected to demonstrate competencies such as Customer Centricity, Developing Talent, Collaboration, Strategic Agility, Process Excellence, Stakeholder Management, Innovation & Creativity, and Result Orientation. Please note that the company's additional details were not provided in the job description.
As a Quality Control Analyst, you will be responsible for the following key responsibilities: - Complying with all cGMP, GxP, or any other regulatory requirements, including EH&S requirements. - Completing training on relevant SOPs and developing an understanding of the activities to be conducted prior to undertaking any task. - Conducting all tasks/activities as per applicable SOPs and reporting any difficulty or deviation in following the procedures/instructions to immediate Supervisors/Managers. - Reporting any quality concerns or suggestions for improvements to supervisors/Managers. - Performing sampling, analysis reporting, and deposition of raw material injectable Raw material as per standard test procedure. Disposing of analyzed samples after analysis and final approval. - Ensuring the OOS & OOT result is communicated to the concern person. - Maintaining sampling kit. - Performing routine calibration of instruments/equipment. - Reviewing documents related to quality control against the standard procedure e.g., analytical raw data and calibration data. - Recording and ensuring the SAP entries of Raw material. - Disposing of leftover samples. - Maintaining the sampling booths in the warehouse. - Initiating and investigating laboratory incidents. - Handling any other assignment allocated by the section in charge/department head. - Filling analytical records and submitting to Doc-cell (as per applicability). - Planning and coordinating Raw Material, executing and supervising all tasks and activities per the applicable SOPs. - Authorizing to print e-TDS from SAP for all types of QC samples. - Reporting events and abnormalities with preliminary investigation findings to Reporting manager, HODs, functional heads, event investigation team, EHS departments managers, and location head. You will need to have the following qualifications: - Masters in Chemistry - Graduation in Pharmacy Additionally, the company values 2 to 5 years of experience in this role. As a Quality Control Analyst, you will be responsible for the following key responsibilities: - Complying with all cGMP, GxP, or any other regulatory requirements, including EH&S requirements. - Completing training on relevant SOPs and developing an understanding of the activities to be conducted prior to undertaking any task. - Conducting all tasks/activities as per applicable SOPs and reporting any difficulty or deviation in following the procedures/instructions to immediate Supervisors/Managers. - Reporting any quality concerns or suggestions for improvements to supervisors/Managers. - Performing sampling, analysis reporting, and deposition of raw material injectable Raw material as per standard test procedure. Disposing of analyzed samples after analysis and final approval. - Ensuring the OOS & OOT result is communicated to the concern person. - Maintaining sampling kit. - Performing routine calibration of instruments/equipment. - Reviewing documents related to quality control against the standard procedure e.g., analytical raw data and calibration data. - Recording and ensuring the SAP entries of Raw material. - Disposing of leftover samples. - Maintaining the sampling booths in the warehouse. - Initiating and investigating laboratory incidents. - Handling any other assignment allocated by the section in charge/department head. - Filling analytical records and submitting to Doc-cell (as per applicability). - Planning and coordinating Raw Material, executing and supervising all tasks and activities per the applicable SOPs. - Authorizing to print e-TDS from SAP for all types of QC samples. - Reporting events and abnormalities with preliminary investigation findings to Reporting manager, HODs, functional heads, event investigation team, EHS departments managers, and location head. You will need to have the following qualifications: - Masters in Chemistry - Graduation in Pharmacy Additionally, the company values 2 to 5 years of experience in this role.