53 Job openings found

The job description is as below: Purpose of the RoleTo ensure timely, accurate, compliant, and scientifically justified responses to regulatory and customer queries related to pharmaceutical and medical device testing, in alignment with global regulatory and accreditation requirements. Key Responsibilities 1. Regulatory Query ManagementReceive, log, track, and respond to regulatory queries, including US ...

  Minimum 20 years in Quality Assurance/Quality Systems in API/pharmaceutical manufacturing, with significant exposure to regulated markets To provide strategic and operational leadership to the Quality function, ensuring robust implementation of quality systems, compliance with global regulatory requirements, and continuous improvement in all quality-related processes for API manufacturing. Key Responsibilities Quality Systems & Compliance Implement, ...

Key Responsibilities: Documentation Management: Review, approve, and control various quality documents, including Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), Batch Packing Records (BPRs), Specifications, Test Procedures (STPs), and other quality-related documentation. Ensure proper archiving, retrieval, and revision control of all controlled documents. Participate in the preparation and review of site master files (SMF), ...

RESPONSIBILITIES:1. To issue the Batch Manufacturing Record, Equipment cleaning record, Logbooks, AnalyticalReport for raw material, finish product and packing material.2. Assistance in preparation of SOP of various departments/ preparation of draft SOPs.3. During plant round QA Executive to verify documents as per cGMP and GLP norms.4. Line Clearance activities for ...

To issue the Batch Manufacturing Record, Equipment cleaning record, Logbooks, Analytical Report for raw material, finish product and packing material. Assistance in preparation of SOP of various departments/ preparation of draft SOPs. During plant round QA Executive to verify documents as per cGMP and GLP norms. Line Clearance activities for manufacturing and packaging ...

Designation: Training Manager Education: Pharmacy/M. Pharmacy Experience: Minimum 12-15 years of experience in production, training and development role in the pharmaceutical industry. Technical Knowledge: In-depth knowledge of Manufacturing and Packaging process. In-depth knowledge of QMS, Batch record, Risk assessment, Qualification and cleaning validation. In-depth knowledge of Operation & Cleaning of pharmaceutical equipment’s and SCADA system. In-depth knowledge of data ...

Lead Production-related QMS activities including SOPs, Deviations, CAPA, Change Control, and Risk Management. Lead OOS/OOT investigations with QA/QC and provide technical inputs. Review batch records, process parameters, equipment, materials, and manufacturing history. Drive root cause analysis, impact assessment, and scientifically justified conclusions. Lead investigations for deviations, process failures, batch discrepancies, yield variations, and equipment ...

Position:       GM Operation Location:      Bhopal Experience:  18 - 25  Years Industries:   Pharma Responsibilities: Sterile Operations & Production Management Oversee aseptic processing, formulation, sterile filtration, and fill-finish operations (isolator technology, restricted access barrier systems - RABS, and lyophilization). Drive production scheduling and capacity utilization while minimizing batch failures, line contamination, or sterile breaches. Manage tech transfers, ...

Position:       GM Operation Location:      Guwahati Experience:  15 - 20  Years Industries:     Pharma Responsibilities: Oversee end-to-end manufacturing operations for Tablets, Capsules, Softgels, and packaging activities to achieve production targets while maintaining quality and delivery timelines. Ensure strict compliance with cGMP, WHO-GMP, regulatory requirements, SOPs, and applicable national and international guidelines. Lead and coordinate with QA, QC, ...

Key Responsibilities Perform testing of raw materials, intermediates, APIs and finished products Handle routine analysis using HPLC, GC, UV, IR, pH meter, KF, etc. Prepare and maintain COA, analytical reports, worksheets and laboratory records Follow GMP, GLP, SOP and data integrity requirements Ensure proper sampling, testing and documentation as per specifications Investigate OOS/OOT results and support ...