6 Jobs in Yadagirigutta

Role & responsibilities Plant Leadership: Serve as the Unit Head, leading all production activities and ensuring efficient, compliant, and safe operations of the Hormonal API facility. Production Management: Oversee daily operations including batch execution, shift planning, manpower deployment, and material availability for smooth production. GMP & Regulatory Compliance: Ensure strict adherence to cGMP, EHS, and regulatory standards (USFDA, WHO, EDQM, etc.). Prepare and face regulatory inspections. Process Optimization: Drive continuous improvement initiatives to enhance productivity, reduce downtime, and improve yield & quality. Cross-functional Coordination: Collaborate with QA, QC, Engineering, SCM, and Regulatory teams to ensure seamless operations. Team Development: Build and nurture a high-performing team. Train and mentor staff on SOPs, safety practices, and technical knowledge. Project Handling: Participate in capacity expansion projects, equipment qualification, technology transfer, and validation activities. Preferred candidate profile Educational Background: B.Tech (Chemical) / M.Sc Experience: 1825 years of experience in API manufacturing, with at least recent 5 years in Hormonal / HPAPI production Skills: Strong leadership, production planning, regulatory exposure, team handling, and problem-solving abilities Location: Willing to work full-time at Yadagirigutta

Job Description We are seeking a highly skilled and experienced Manager Plant Maintenance for our API Manufacturing Plant located at Yadagirigutta. The ideal candidate will be solely responsible for managing all plant maintenance activities and ensuring seamless operations through preventive, breakdown, and predictive maintenance practices. Role & responsibilities Plant Equipment Maintenance: Oversee the maintenance and smooth functioning of all process equipment such as Reactors, Centrifuges, ANFDs, Isolators, Vacuum Pumps, etc. Utility Equipment Maintenance: Ensure the upkeep and efficiency of utility systems including Chillers, Boilers, HVAC, LAFs , and other essential support systems. Installation & Qualification: Lead the installation, commissioning, and qualification of new equipment as per cGMP and regulatory guidelines. Engineering Documentation: Responsible for maintaining all necessary documentation related to the Engineering department including maintenance logs, calibration records, validation reports, and SOPs. Compliance & Safety: Ensure compliance with GMP, regulatory standards, and EHS (Environment, Health & Safety) norms during all engineering operations. Team Management: Supervise a team of technicians and contractors to ensure timely execution of maintenance tasks. Continuous Improvement: Implement engineering best practices and support continuous improvement initiatives to enhance operational efficiency. Preferred candidate profile Education: B.Tech in Mechanical Engineering (Mandatory) Experience: Minimum 10 to 15 years in API / Pharmaceutical plant maintenance Technical Expertise: Strong knowledge of mechanical systems, process equipment, utility systems, cGMP, and documentation protocols Leadership Skills: Ability to lead and coordinate with cross-functional teams Location: Willing to work at our API Plant in Yadagirigutta

Role & responsibilities Manage and control the entire warehouse operations, including receipt, storage, issuance, and dispatch of materials (raw materials, intermediates, packaging materials, consumables, and finished goods). Ensure material handling procedures comply with cGMP, GDP, and EHS regulations, particularly for Hormonal / HPAPI / Oncology materials. Supervise warehouse operations within controlled environments (temperature, humidity, and containment) to maintain material integrity. Ensure proper segregation and storage of materials (quarantined, released, rejected, returned). Implement and maintain proper inventory control systems (FIFO, FEFO) and conduct cycle counting and physical stock verification. Coordinate with QA/QC for material sampling, clearance, and material status updates. Maintain accurate records in ERP systems (SAP / Oracle / equivalent) for material movement, stock levels, and expiry/damage tracking. Oversee material issuance for production as per batch requirements and ensure timely availability. Ensure strict documentation practices, material traceability, and audit readiness. Manage the storage and safe disposal of hazardous, expired, and rejected materials in compliance with environmental regulations. Lead a team of warehouse staff including supervisors, material handlers, and forklift operators. Implement and monitor KPIs for warehouse efficiency, accuracy, and safety. Support external and internal audits by providing accurate and complete documentation. Preferred candidate profile Strong understanding of warehousing operations in regulated API environments Hands-on knowledge of GDP, cGMP, and containment protocols (especially for HPAPI/Hormone/Oncology) Experience in material handling equipment, ERP systems, and warehouse automation Ability to lead warehouse teams and coordinate with cross-functional departments Knowledge of EHS standards related to HPAPI and hazardous material handling Attention to detail and compliance-driven mindset

Role & responsibilities Manage and maintain all production-related documentation, including Batch Manufacturing Records (BMRs), SOPs, Logbooks, and Validation Protocols. Review and ensure timely preparation, issuance, and retrieval of GMP documents in accordance with cGMP and GDP requirements. Coordinate with the QA and Production teams to ensure documentation accuracy and completeness. Lead documentation readiness for audits (regulatory, customer, and internal). Support and coordinate the preparation of audit responses, CAPA documentation, and follow-up actions. Ensure timely updates and version control of SOPs and Master Manufacturing Records. Implement document control systems and ensure document security and traceability. Monitor change control, deviations, and incident documentation related to production operations. Ensure compliance with data integrity and documentation best practices. Collaborate with cross-functional teams to enhance regulatory compliance culture on the shop floor. Provide training on documentation practices, cGMP, GDP, and audit readiness to production staff. Maintain and track compliance metrics and drive continuous improvement in documentation practices. Participate in regulatory inspections and ensure the availability of relevant documentation. Preferred candidate profile In-depth understanding of cGMP, GDP, and regulatory audit requirements Experience in handling documentation for USFDA, EU, WHO, and other regulatory bodies Strong analytical and detail-oriented mindset Excellent written and verbal communication skills Proficiency in documentation systems and electronic document management (EDMS) Ability to train and mentor teams on compliance practices

Role & responsibilities Supervise daily production operations in the hormone manufacturing block. Monitor batch execution as per approved schedules and ensure timely delivery. Maintain accurate documentation including BMRs, logbooks, and deviation records. Adhere strictly to cGMP, GDP, and EHS protocols in hormone manufacturing. Coordinate with QA, QC, Engineering, and SCM for smooth operations. Support process validation, scale-up, and equipment qualification activities. Ensure proper handling and disposal of hormone-related materials and wastes. Implement and monitor cleanroom protocols and environmental standards. Ensure compliance with regulatory requirements (USFDA, EU, WHO, etc.). Train and guide production operators and junior staff on SOPs, safety, and best practices. Maintain equipment readiness through coordination with maintenance teams. Participate in internal and external audits, and provide necessary production data. Monitor production KPIs and suggest improvements for operational efficiency. Preferred candidate profile Strong understanding of hormone/HPAPI production processes Working knowledge of cGMP, GDP, and regulatory standards Experience in handling regulated audits (USFDA, EU, WHO preferred) Effective communication and team supervision skills Familiarity with cleanroom operations and containment protocols

Role & responsibilities 1. Ensure compliance with cGMP, safety, and statutory requirements in warehouse operations. 2. Manage receipt, inspection, storage, sampling, issuance (FIFO), and dispatch of materials. 3. Maintain and review SOPs, GMP records, bin cards, and warehouse documentation (eDMS). 4. Oversee training, task allocation, and performance monitoring of warehouse personnel. 5. Monitor equipment calibration, housekeeping, preventive maintenance, and validations. 6. Track inventory status including non-moving, rejected, and re-test materials. 7. Handle deviations, change controls, CAPA, and risk mitigation activities. 8. Coordinate with QA, QC, R&D, HR, and Engineering to ensure smooth warehouse functioning. Desired Candidate Profile Strong understanding of SAP systems and ability to work on them effectively. Excellent communication skills for effective collaboration with team members.