Technical Expert
5 days ago
- 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
3 days ago
Pune, Maharashtra, India Avalara Technologies Full time ₹ 1,04,000 - ₹ 1,30,878 per yearJob 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...
-
Design Engineer
5 days ago
Pune, Maharashtra, India Awign Expert Full time ₹ 10,00,000 - ₹ 25,00,000 per yearJob 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...
-
Network -Technical Services Engineer Expert
1 week ago
Pune, Maharashtra, India Fujitsu Full time ₹ 15,00,000 - ₹ 25,00,000 per yearTechnical Services Engineer Expert(Network role)Exp: 8+yearsLocation: PuneAssessing company network needs, network systems, applying troubleshooting skills to resolve network issues.Analyze gaps & design network solutions with latest technologies.Excellent knowledge with Juniper, Cisco, Palo Alto, Prisma, SDWAN, SDN, & Azure technology etc.Preferred CCNP,...
-
Technical Support Expert
2 weeks ago
Pune, Maharashtra, India, Maharashtra Antal International Full timeThis opportunity is with a product-based company into Fintech environment specializing in Cards & Payment Technology.Role - Expert Support II/IIIExperience - 8 to 15 yearsNP - Immediate to 15 daysLocation - PuneWork Mode - 5 days WFOBudget - 32 LPAKey Skills - PL/SQL, Unix/ Linux, Production Support, Application support.Secondary Skills - C & Testing...
-
Project Implementation Expert
3 hours ago
Pune, Maharashtra, India Rapsys Technologies PTE LTD Full time ₹ 9,00,000 - ₹ 12,00,000 per yearRole : Implementation Expert We are seeking a skilled Implementation Expert to lead and manage the deployment of software solutions and systems for our clients. The ideal candidate will have strong technical expertise, project management skills, and the ability to ensure seamless implementation processes while maintaining high-quality standards and...
-
Technical Expert- Production
2 weeks ago
Pune, Maharashtra, India Fresenius Kabi Full time ₹ 9,00,000 - ₹ 12,00,000 per yearCandidates can apply on rashmi.-Job Purpose:To operate and maintain autoclave equipment used in the sterilization of components, garments, and materials in the LVP manufacturing area, ensuring compliance with cGMP, SOPs, and safety standards.Key Responsibilities:Operate steam sterilizers (other autoclaves) for sterilizing LVP components such as rubber...
-
Aviation MRO Expert
5 days ago
Pune, Maharashtra, India Fortune Business Insights™ Full time ₹ 9,00,000 - ₹ 12,00,000 per yearCompany DescriptionFortune Business Insights offers comprehensive market studies and consulting services to global businesses. Through in-depth research, trend analysis, and refined forecasting, we provide actionable recommendations to help businesses establish a strong brand identity and achieve transformational growth. Our solutions include both syndicate...
-
Subject Matter Expert
1 week ago
Pune, Maharashtra, India Ghrs Training Full time ₹ 4,00,000 - ₹ 8,00,000 per yearRole - Process Specialist | Subject matter expertExp - Min 2 yearsSkill - Technical support | Service desk | IT Help desk Loc - Pune | WFO | 5 Days working 2 days rotational offNotice - immediate to 30 Days
-
jira expert
5 days ago
Pune, Maharashtra, India Ubique Systems Full time ₹ 2,40,000 - ₹ 3,60,000 per yearJob Title: Jira ExpertLocation: Pune – EON Cluster D (INVS_1)Position Type: Full-Time (FTE via Quess Corp), Client: VodafoneMode of Work: Hybrid (One round virtual interview)Experience Required: 7+ Years Total, with 2.5–4 Years Relevant in JiraBudget: Up to 20 LPANotice Period: Immediate Joiners Only________________________________________Job...
-
performance marketing expert
2 hours ago
Pune, Maharashtra, India Omegasoft Technologies Pvt Ltd Full time ₹ 4,00,000 - ₹ 12,00,000 per yearCompany DescriptionOmegaSoft Technologies Pvt Ltd is a leading software solutions company based in Pune, specializing in website development, digital marketing, SEO, SMO, and e-commerce services. With a reputation for quality and technical expertise, OmegaSoft has been delivering services to over a hundred clients since 2012. The company excels in digital...