We need candidate who intrested to relocate in jammu Total open position -3 for different profiles Pharmaceutical Manfacturing Unit Need only experiences candidate
We need QA ( quality assurance executive from pharma field only ) experience candidate can apply only
Technician /Sr. Operator /Operator (Pellets Manufacturing) Process Expertise: Extrusion–Spheronisation & Fluid Bed Coating (FBC) 1. Equipment Operation: Operate extrusion–spheronisation equipment as per approved Batch Manufacturing Record (BMR) and Standard Operating Procedures (SOPs). Set up, operate, and monitor extruder, spheroniser, and fluid bed coater to achieve desired pellet quality and yield. Ensure equipment parameters are maintained as per formulation and process requirements. 2. Batch Processing: Accurately weigh, measure, and load raw materials and excipients as per batch records. Execute all stages of the pellet manufacturing process, including wet massing, extrusion, spheronisation, drying, and coating. Continuously monitor in-process parameters such as pellet size, moisture content, sphericity, and coating weight gain. 3. In-Process Control (IPC): Perform in-process checks and record results accurately in log books and BMR. Immediately report any deviations, abnormalities, or equipment malfunctions to the Production Officer /Supervisor. Maintain required in-process quality standards to ensure uniformity and compliance. 4. Equipment Cleaning & Maintenance: Perform cleaning, changeover, and minor maintenance of extruder, spheroniser, and fluid bed coater as per SOP. Ensure proper line clearance before and after batch processing. Participate in preventive maintenance activities and support qualification/calibration as needed. 5. Documentation & Compliance: Record all manufacturing activities, process parameters, and observations accurately in relevant documents. Ensure compliance with cGMP, SOPs, and safety guidelines throughout production operations. Assist in preparing cleaning records, logbooks, and equipment usage records. 6. Safety & Housekeeping: Follow all safety protocols while handling equipment and materials. Use personal protective equipment (PPE) as required. Maintain cleanliness and orderliness in the production area to meet audit and regulatory standards. 7. Coordination & Support: Work closely with production chemists, supervisors, and QA personnel during batch manufacturing and line clearance. Support scale-up, validation, and routine commercial batches under supervision. Assist in training junior operators or new team members.
EXPORT Manager /Assistant Manager Regulatory Affairs Expertise: Asian & African Countries 1. Regulatory Strategy & Compliance Develop and implement regulatory strategies to ensure timely approvals for new products, variations, and renewals. Ensure compliance with national and international regulatory requirements (e.g., PIC/s, EMA, WHO, ICH, etc.) across all stages of product development and manufacturing. Interpret and communicate updated regulatory guidelines, notifications, and circulars to relevant internal departments. 2. Dossier Preparation & Submission Oversee and review the preparation, compilation, and submission of regulatory dossiers (e.g., CTD/eCTD, ACTD formats) for new product registrations, site approvals, and product renewals. Coordinate with cross-functional teams (R&D, QA, QC, Production, Packaging) to gather and validate required data for regulatory filings. Ensure timely submission of regulatory applications and responses to queries from regulatory agencies. 3. Liaison with Regulatory Authorities Act as the primary contact with regulatory bodies (e.g., CDSCO, State FDAs, and International agencies). Facilitate product /site inspections, audits, and pre-approval inspections by regulatory agencies. Handle communications, deficiency responses, and follow-ups to achieve approvals in a timely manner. 4. Product Lifecycle Management Manage regulatory activities throughout the product lifecycle, including post-approval changes, labeling updates, renewals, and variations. Monitor regulatory commitments and ensure timely compliance with all post-approval obligations. 5. Documentation & Record Maintenance Maintain and control all regulatory documents, dossiers, and submission archives in an organized and secure manner. Ensure all regulatory files are updated and readily available for inspections or audits. 6. Team Leadership & Training Lead and mentor the regulatory affairs team to ensure smooth execution of regulatory activities. Conduct internal training sessions to keep relevant departments updated with the latest regulatory guidelines and requirements. 7. Regulatory Intelligence & Risk Management Monitor global regulatory trends, changes in legislation, and competitive intelligence to assess potential impacts on the organization. Identify regulatory risks and develop proactive mitigation strategies. 8. Support for Business Development & Exports Provide regulatory support for business development activities including due diligence, product portfolio expansion, and entering new markets. Manage product registrations and renewals in various export markets through coordination with overseas agents/partners.
We need pcd pharma sales executive Attractive Incentives