Designer Qualification: Any Graduate / Post Graduate Roles & Responsibilities: Export inquiry handling. Export follow ups. Point of contact for export consignment coordination with other department. Communicate order stutus delivery. MIS reports from ERP. Trademark software use.
Role & responsibilities Responsible for following activities: a. Verify cGMP, GDP, GLP and data integrity practices, compliance in Quality Control and microbiology laboratory. b. Review of Specification, Standard test procedures and test data sheet for adequacy and accuracy. c. Review Validation and calibrations of all Instruments. d. Review of AMV, AMT Protocols and reports. e. Handling of Lab incidents, Deviations, OOS, OOC, OOT etc. f. Handling of reserved sample of finished products and its visual inspection. g. Review of trend data of environmental monitoring, water analysis. h. Participation in audit the contract testing laboratory. Preferred candidate profile ERP/ QMS/QC software system handling experience
Role & responsibilities : a. Plan, manage, and oversee the work activities of QC and Microbiology laboratories to ensure lab testing provides the highest quality analytical support for manufacturing in a timely and compliant manner, adhering to protocols, cGLP, and safety regulations. b. Manage analytical method validation of products, method transfer, stability studies, and related activities to ensure compliance with regulatory and quality standards c. Provide leadership, management, performance evaluation, and training to all laboratory employees to maintain a competent and motivated team. d. Execute and approve all laboratory operations, including reviewing and investigating any laboratory data that is outside of established trends. e. Ensure all vendors are qualified and comply with vendor qualification standards, aiming for optimal utilization of reduced testing procedures. f. Establish and implement a KPI system to ensure an optimal balance between test quality and cost efficiency. g. Collaborate closely with other departments to ensure the plant's compliance with the Quality Management System (QMS). Preferred candidate profile Candidates having experiences in Pharma formulation(OSD) of EU/USFDA plant are preferred
Role & responsibilities 1. Prepare, compile, and review regulatory dossiers for submission. 2. Respond to queries and deficiency letters from regulatory authorities in coordination with technical teams. 3. Co-ordinating with cross-functional teams like R&D, QA/QC, production to collection of data for submissions. 4. Maintain regulatory files and track submission and approval status using internal systems. 5. Provide regulatory input during product development, scale-up, and lifecycle management. 6. Supporting the review of product labels, cartons, and inserts to ensure compliance with regulations. 7. Ensure products comply with all regulatory requirements through each stage of development and commercialization. 8. Conduct training sessions on regulatory updates and internal System 9. Ensure documentation is audit-ready and aligned with internal SOPs and regulatory expectations. 10. Support internal and external audits by providing required regulatory documents and justifications. 11. Guide and review work of junior team members or trainees. 12. Review and interpret regulatory guidelines and notify stakeholders of relevant updates. 13. Review of all dossiers related technical documents Preferred candidate profile Experience in reviewing of Analytical documents
The Process Coordinator in the Admin Department plays a crucial role in ensuring the alignment and efficiency of processes and workflows. You will be responsible for utilizing your Excel skills to track processes, make entries, and generate reports. It will also be your duty to maintain documentation, records, and files, ensuring that both hard and soft copies are properly updated. In case of workflow issues or bottlenecks, you are expected to identify and escalate these to the management for resolution. Collaboration with other departments is essential for the smooth functioning of related work. This is a full-time position that offers benefits such as life insurance and provident fund. The work schedule is during the day shift, and there is a yearly bonus provided. The ideal candidate should have at least 1 year of total work experience. The work location is in person. If you are interested in this role, please contact the employer at +91 7498035480 for further discussions.,
Role & responsibilities : 1) Having from OSD background. 2) Responsible for analysis of RM/IP/FG/Stability on HPLC. 3) Responsible for Calibration of HPLC 4)Having the Knowledge of the Pharmacopeia.IP/BP/Ph.Eur/USP Skill Required: 1) Handling of the HPLC, 2) Calibration Management. 3)Knowledge of the GLP Environment 4) Handling of the HPLC, 5) Calibration Management. 6)Working Standard, Ref. Standard, Imp Standard, Primary Standard Management Additional Remark: Required candidates background should be in Regulatory environments
As a Process Co-ordinator in the Admin Department, you will be responsible for coordinating processes and workflows to ensure alignment and efficiency within the organization. Your role will involve utilizing your excel skills for process tracking, data entries, and report generation. Additionally, you will be required to maintain documentation, records, and files, ensuring proper updates in both hard and soft copies. Identifying and escalating workflow issues and bottlenecks to the management team will be a crucial part of your responsibilities. You will also be expected to coordinate with other departments to ensure the smooth functioning of related work processes. This is a full-time position with benefits including life insurance and provident fund. The work schedule is during the day shift, and there is a yearly bonus offered. The ideal candidate should have at least 1 year of total work experience. The work location is in person. If you are interested in this position, please contact the employer at +91 7498035480 for further details.,
As a Graphic Designer at our company, you will be responsible for creating innovative designs for various print materials. Your role will involve collaborating with different departments to ensure that all designs meet quality standards and are production-ready. Additionally, you will work on digital marketing designs, branding artwork, and video editing tasks as needed. Your qualifications should include a degree in Graphic Design, Commercial Art, or a related field. You should have at least 1 year of experience and be proficient in using Adobe Creative Suite, including Photoshop, and CorelDRAW. Your key responsibilities will include: - Generating ideas and designing print materials such as visual aids, product literatures, brochures, catalogs, cartons, labels, blister strips, gift boxes, packaging stickers, etc. - Liaising with Regulatory, QA/QC, Production, and Marketing teams to ensure design accuracy and compliance. - Creating print-ready files according to departmental and vendor specifications. - Handling design tasks related to internal branding, equipment labeling, safety signs, etc. - Coordinating with external printers and packaging vendors for proofing and final output. - Engaging in digital marketing designs, branding artwork, and video editing projects as required. - Undertaking any other artwork-related assignments as delegated by the Reporting Head. If you are a creative individual with a passion for design and a keen eye for detail, we encourage you to apply for this exciting opportunity to showcase your skills and contribute to our company's success.,
Department: Quality Assurance Designation : Officer/Sr. Officer Experience : 2+ years Highest Qualification: B. Pharm Roles & Responsibilities: 1. To give line clearance at various stages like Dispensing, Granulation, Compression, coating, Inspection, Capsule filling, Bulk manufacturing, tube filling and packing. 2. To Perform sampling such as in in-process, semi-finished, finished, control samples, stability samples, validation samples, record it and to send samples to QC. 3. To perform Sampling of Swab and Rinse sample and maintain its logbooks. 4. To perform Calibration of IPQA instruments and maintain its formats/logbooks. 5. To review BMR and BPR.
Department: Regulatory Affairs Designation : Sr. Officer Experience : 1 to 4 years Highest Qualification: M. Pharm Roles & Responsibilities: 1. Prepare, compile, and review regulatory dossiers for submission. 2. Respond to queries and deficiency letters from regulatory authorities in coordination with technical teams. 3. Co-ordinating with cross-functional teams like R&D, QA/QC, production to collection of data for submissions. 4. Maintain regulatory files and track submission and approval status using internal systems. 5. Provide regulatory input during product development, scale-up, and lifecycle management. 6. Supporting the review of product labels, cartons, and inserts to ensure compliance with regulations. 7. Ensure products comply with all regulatory requirements through each stage of development and commercialization. 8. Conduct training sessions on regulatory updates and internal System 9. Ensure documentation is audit-ready and aligned with internal SOPs and regulatory expectations. 10. Support internal and external audits by providing required regulatory documents and justifications. 11. Guide and review work of junior team members or trainees. 12. Review and interpret regulatory guidelines and notify stakeholders of relevant updates.
Leben life Sciences pvt Ltd is looking for Officer/Sr. Officer to join our dynamic team and embark on a rewarding career journey Operational Management: Oversee day-to-day operations within their area of responsibility, ensuring efficiency, productivity, and adherence to organizational goals and standards Project Coordination: Lead and coordinate projects, initiatives, or tasks assigned to their department or team Develop project plans, timelines, and budgets, and ensure successful project execution Team Leadership: Provide leadership, guidance, and mentorship to team members, fostering a positive work environment, encouraging professional growth, and promoting teamwork and collaboration Process Improvement: Identify opportunities for process improvement, optimization, and streamlining of workflows Implement changes, best practices, and efficiency measures to enhance operational effectiveness Stakeholder Engagement: Collaborate with internal and external stakeholders, including colleagues, clients, vendors, and partners, to achieve shared objectives, address challenges, and foster positive relationships Data Analysis and Reporting: Analyze data, metrics, and key performance indicators (KPIs) relevant to their area of responsibility Prepare reports, presentations, and dashboards to communicate insights, trends, and recommendations to management and stakeholders Problem Solving and Decision Making: Identify issues, challenges, and obstacles hindering progress or performance Develop solutions, make informed decisions, and take proactive steps to address issues and achieve desired outcomes Compliance and Risk Management: Ensure compliance with relevant laws, regulations, policies, and standards governing their area of operation Identify and mitigate risks, vulnerabilities, and compliance gaps through effective risk management practices Customer Relationship Management: Maintain positive relationships with customers, clients, or end-users of products or services offered by their department or organization Address customer inquiries, feedback, and concerns in a timely and satisfactory manner
Leben life Sciences pvt Ltd is looking for Sr. Officer to join our dynamic team and embark on a rewarding career journey The Senior Officer plays a crucial role in the organization, responsible for overseeing and executing various tasks and projects to ensure the smooth functioning of operations This role requires strong leadership, analytical skills, and the ability to collaborate effectively with team members and stakeholders Key Responsibilities: Leadership:Provide leadership and guidance to team members, fostering a positive work environment Lead by example, demonstrating professionalism, integrity, and dedication to the organization's goals and values Project Management:Manage and coordinate projects from initiation to completion, ensuring adherence to timelines and budget constraints Develop project plans, allocate resources, and monitor progress to achieve project objectives Identify and mitigate risks to project success, implementing appropriate solutions as needed Operational Efficiency:Streamline processes and procedures to improve operational efficiency and effectiveness Identify opportunities for automation or technological enhancements to optimize workflow and productivity Collaborate with cross-functional teams to implement process improvements and best practices Data Analysis and Reporting:Analyze data to identify trends, patterns, and insights relevant to the organization's objectives Generate reports and presentations to communicate findings and recommendations to key stakeholders Utilize data-driven insights to inform decision-making and drive continuous improvement initiatives Stakeholder Engagement:Build and maintain relationships with internal and external stakeholders, including clients, partners, and vendors Collaborate with stakeholders to understand their needs and requirements, ensuring alignment with organizational objectives Effectively communicate project updates, issues, and resolutions to stakeholders, fostering transparency and trust Compliance and Risk Management:Ensure compliance with relevant laws, regulations, and internal policies and procedures Proactively identify and address potential risks and compliance issues, implementing appropriate controls and safeguards Keep abreast of industry developments and best practices to inform risk management strategies
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