Technical Expert

2 days ago

Pune, Maharashtra, India Fresenius Kabi Full time ₹ 20,00,000 - ₹ 25,00,000 per year
  1. Hi,

Pl send Updated CV on Rashmi.-

Details as below :

1. Position : Senior Technical Expert- Quality Assurance

Key Responsibilities: - Validation Profile

  • Validation Planning & Execution:

  • Develop, review, and approve Validation Master Plans, Validation Protocols (IQ/OQ/PQ), and Reports for equipment, utilities, and manufacturing processes.

  • Lead validation activities for injectable dosage forms, including aseptic processing, lyophilization, and sterile filtration.

  • Ensure validation activities comply with cGMP, FDA, EU, and other applicable regulatory standards1.

  • Documentation & Compliance:

  • Maintain and update Site Master File, Annual Product Reviews, and Validation Summary Reports 2.

  • Review and approve SOPs, Work Instructions, and Change Control documentation.

  • Ensure traceability and archival of all validation documents.

  • Cross-functional Collaboration:

  • Coordinate with Production, Engineering, QC, and Regulatory Affairs to align validation efforts with project timelines.

  • Support audits and inspections by providing validation documentation and responding to observations.

  • Deviation & CAPA Management:

  • Investigate validation-related deviations and implement Corrective and Preventive Actions (CAPA).

  • Conduct risk assessments and impact analyses for changes to validated systems 3.

  • Training & Support:

  • Train operators and analysts on validation protocols and regulatory expectations.

  • Provide technical support during equipment qualification and process validation.

2. Position : Technical Lead- Quality Assurance

Key Responsibilities: Batch Release

  • Batch Documentation Review:

  • Review Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) for completeness, accuracy, and compliance with cGMP.

  • Ensure all documentation supports batch release and adheres to data integrity standards.

  • Product Release Authorization:

  • Authorize release of raw materials, intermediates, and finished injectable products.

  • Ensure specifications are met and documented evidence supports product quality.

  • Deviation & CAPA Management:

  • Escalate discrepancies and deviations promptly.

  • Participate in investigations and ensure Corrective and Preventive Actions (CAPA) are implemented and closed.

  • Compliance & Regulatory Support:

  • Ensure batch release activities comply with FDA, EU, and WHO GMP guidelines.

  • Support internal and external audits by providing batch documentation and responding to queries.

  • Cross-functional Collaboration:

  • Coordinate with Production, QC, Regulatory Affairs, and Warehouse teams to ensure timely and compliant product disposition.

  • Support continuous improvement initiatives in batch release processes.

  • Documentation Control:

  • Manage issuance, filing, and archival of executed batch records.

  • Maintain batch documentation library and ensure traceability.

  • Technical Support Expert

    13 hours ago

    Pune, Maharashtra, India Avalara Technologies Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    Job SummaryYou will report to the Manager, Technical Support. You will work from the Pune office full fledged.The Technical Support Expert serves as a Subject Matter Expert (SME) for AvaTax, ECM, and related Connector products, providing top-tier technical expertise and analysis to support Avalara's customers. You will mentor and advise across the support...

  • Technical Support Expert

    3 weeks ago

    Pune, Maharashtra, India Avalara Full time

    What You ll DoYou will report to the Manager Technical Support You will work from the Pune office The Technical Support Expert serves as a Subject Matter Expert SME for AvaTax ECM and related Connector products providing top-tier technical expertise and analysis to support Avalaras customers You will mentor and advise across the support ecosystem ...

  • Technical Support Expert

    3 weeks ago

    Pune, Maharashtra, India Avalara Technologies Full time

    Job Description- Be a Subject Matter Expert on Avalara product integrations.- Mentor and advise support teams and associated PODs.- Simplify and enhance customer interactions for support requests.- Manage and resolve Level 3 technical issues for AvaTax, ECM, and related Connectors.- Conduct detailed ticket analysis, troubleshooting, and issue replication.-...

  • Software Technical Expert

    4 weeks ago

    Pune, Maharashtra, India amdocs Full time

    Job ID 201704 Required Travel Minimal Managerial - No Location India- Pune Amdocs Site In one sentence Responsible for MS360 implementation and customization for account teams customers on AWS GCP and Azure cloud Work closely with customer technical teams as MS360 professional consultant and bring feedback to platform foundation teams to evolve...

  • Design Engineer

    4 days ago

    Pune, Maharashtra, India Awign Expert Full time ₹ 10,00,000 - ₹ 25,00,000 per year

    Job DescriptionLocation: PuneDuration: 12 Months with possible extensionOverall Experience: Minimum 10 YearsThe Design Engineer will own the maintenance and strategic roadmap for our Core design system. In this role, they will ensure the system is operational and meets the needs of our business users. They'll drive the future of the design system ensuring...

  • Associate Engineer

    4 weeks ago

    Pune, Maharashtra, India Expert Global Group Full time

    Hi,Greetings of the DayWe are urgently looking for a Associate Engineer for Pune Location.ALTEN is a French multinational technology consulting and engineering company founded in 1988, it has offices in 25 countries. Expert Global Solutions Pvt Ltd is a Group company of Alten (India) an ISO 9001:2008 certified company founded in 1991, providing engineering...

  • Associate Engineer

    4 weeks ago

    Pune, Maharashtra, India Expert Global Group Full time

    Hi, Greetings of the Day We are urgently looking for a Associate Engineer for Pune Location. ALTEN is a French multinational technology consulting and engineering company founded in 1988, it has offices in 25 countries. Expert Global Solutions Pvt Ltd is a Group company of Alten (India) an ISO 9001:2008 certified company founded in 1991, providing...

  • Technical Support Engineer

    4 days ago

    Pune, Maharashtra, India Avalara Technologies Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    What You'll DoYou will report to the Manager, Technical Support. You will work from the Pune office full fledged.The Technical Support Expert serves as a Subject Matter Expert (SME) for AvaTax, ECM, and related Connector products, providing top-tier technical expertise and analysis to support Avalara's customers. You will mentor and advise across the support...

  • AEM Technical Architect

    7 days ago

    Pune, Maharashtra, India PradeepIT Consulting Services Pvt Ltd Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job Responsibilities Years of Experience: 10+ Technologies: Adobe Experience Suite, React, HTML5, CSS, JavaScript, jQuery, Java, J2EE, continuous deployment and DevOps tools, GIT Responsibilities: Translate business goals into technical requirements, conduct code/design reviews, and drive the technical implementation of web projects throughout the project...

  • Technical Project Manager

    2 weeks ago

    Pune, Maharashtra, India IncubXperts Full time

    Job DescriptionThe RoleAs a Technical Project Manager, your mission is to lead enterprise software development initiatives by combining strong project management discipline with deep technical understanding and domain expertise related to FinTech or Banking or Billing and Payments domain. You will act as a bridge between product management, development...