Job Summary: We are looking for a highly motivated and detail-oriented Assistant Manager Quality to join our quality team. The ideal candidate will be responsible for overseeing quality assurance (QA) and/or quality control (QC) activities to ensure compliance with regulatory standards (cGMP, WHO, FDA, etc.) and internal quality policies. This role is vital in maintaining product integrity and supporting continuous improvement initiatives. Key Responsibilities: Supervise and support QA/QC operations, including IPQA, documentation, and in-process checks. Ensure adherence to GMP guidelines and regulatory requirements in manufacturing and packaging. Review and approve quality-related documents such as SOPs, BMRs, BPRs, and change controls. Conduct and support internal audits, vendor audits, and regulatory inspections. Investigate deviations, out-of-specification (OOS) results, and non-conformities. Ensure timely CAPA implementation and monitoring. Manage sampling, testing, and release of raw materials, packaging materials, and finished products. Train and mentor junior QA/QC staff on SOPs, GMP, and safety standards. Coordinate with cross-functional departments including Production, R&D, and Regulatory Affairs.
Roles and Responsibilities Develop project plans, schedules, and budgets; track progress against targets using MS Project software. Manage engineering projects from concept to delivery, ensuring timely completion within budget and quality standards. Ensure compliance with CGMP regulations during manufacturing processes through effective documentation and risk mitigation strategies. Collaborate with cross-functional teams to identify potential risks and develop contingency plans for successful project execution. Provide technical guidance on SOPs (Standard Operating Procedures) development and implementation. Desired Candidate Profile B.Tech/B.E. degree in Any Specialization or M.Tech degree in Any Specialization required. Strong understanding of project planning, scheduling, cost optimization, regulatory compliance, risk mitigation, and budget management principles.
Key Responsibilities : 1. Documentation & Compliance : Review and approval of SOPs , BMRs , BPRs , specifications , and test procedures . Ensure compliance with cGMP , ICH , WHO , USFDA , EU , and other applicable regulatory guidelines. Handling change control , deviation , CAPA , and out-of-specification (OOS) reports. 2. Internal & External Audits : Preparation and coordination for regulatory inspections (USFDA, EDQM, WHO, etc.) and customer audits . Execution of internal audits and follow-up for corrective actions. Ensure site readiness at all times for surprise inspections. 3. Validation & Qualification : Review and approval of process validation , cleaning validation , and equipment qualification protocols and reports. Coordination with production and QC for validation activities. 4. Vendor Qualification & Material Review : Evaluate and qualify vendors as per SOP. Review and approval of COAs , RM/PM specifications , and sampling plans . 5. Batch Release & QA Shop Floor Activities : Review and release of API batches after ensuring compliance with specifications and documentation. Perform line clearance , in-process checks , and documentation review on the shop floor. 6. Training & Development : Conduct GMP training , SOP training , and quality system awareness sessions for cross-functional teams. Maintain training records and competency evaluations. Required Skills & Competencies : Strong knowledge of GMP guidelines , QMS , ICH , and international regulatory standards. Good understanding of analytical techniques and laboratory compliance . Sound knowledge of API manufacturing process flow. Excellent documentation and communication skills. Proficiency in tools like TrackWise , LIMS , or similar QA systems is an added advantage. Preferred Industry Experience : Minimum 6 years of QA experience in API manufacturing (not formulations). Exposure to regulatory inspections and international quality standards .
Key Responsibilities 1. Electrical Maintenance & Troubleshooting Perform preventive, predictive, and breakdown maintenance for electrical systems, MCC panels, VFDs, motors, lighting, UPS, and generators. Diagnose electrical faults and restore equipment operation with minimal downtime. Maintain and repair control circuits, distribution boards, and wiring systems. 2. Utilities & Plant Equipment Maintain electrical systems for utilities like boilers, chillers, cooling towers, water treatment plants, and HVAC systems. Monitor and ensure proper functioning of DG sets, transformers, and substations. 3. Installation & Commissioning Support installation and commissioning of electrical systems for new process equipment. Ensure wiring diagrams, load calculations, and cable schedules are up to date. 4. Compliance & Documentation Maintain records of preventive maintenance, breakdown reports, and calibration of electrical instruments as per GMP. Ensure compliance with statutory norms (Electrical Inspectorate, ISO, cGMP, EHS). Support audits (internal, regulatory, EHS) with required documentation. 5. Energy Management & Safety Implement energy-saving initiatives and monitor electrical consumption. Ensure electrical safety practices, grounding systems, and protection devices are in place. Conduct safety training and toolbox talks for electrical operations. Qualifications & Experience Education: Diploma / B.E. / B. Tech in Electrical Engineering. Experience: 3 to 8 years (preferably in API / Bulk Drug / Chemical manufacturing). Knowledge of: Electrical maintenance, PLC basics, industrial wiring, DG & transformer operation, cGMP requirements. Skills: Fault finding, preventive maintenance scheduling, documentation, vendor coordination. Key Competencies Strong technical knowledge of plant electrical systems and controls. Awareness of GMP, safety, and statutory electrical norms. Quick problem-solving ability under breakdown situations. Good coordination skills with Production, QA, EHS, and Vendors.
Key Responsibilities 1. Maintenance & Troubleshooting Perform preventive, predictive, and breakdown maintenance for mechanical equipment such as reactors, centrifuges, dryers, heat exchangers, pumps, agitators, boilers, and compressors. Diagnose and rectify mechanical faults to minimize downtime. Maintain mechanical seals, bearings, gaskets, and alignment of rotating equipment. 2. Utilities & Facility Management Monitor and maintain utility systems (chilled water plant, air compressors, boilers, cooling towers, water treatment plants). Ensure energy efficiency and reliability of utility systems. 3. Equipment Installation & Commissioning Participate in installation, commissioning, and validation of new equipment. Ensure mechanical drawings and documentation are updated. 4. Compliance & Documentation Maintain maintenance logs, calibration records, and mechanical drawings as per GMP requirements. Adhere to safety, health, and environmental regulations (OSHA, ISO, cGMP). Support engineering audits and provide necessary documentation to QA and regulatory authorities. 5. Continuous Improvement Identify and implement modifications to improve efficiency, safety, and reliability of mechanical systems. Support projects related to capacity enhancement, energy savings, and automation. Qualifications & Experience Education: Diploma / B.E. / B.Tech in Mechanical Engineering. Experience: 3 to 8 years (preferably in API / Bulk Drug / Chemical manufacturing). Knowledge of: GMP, mechanical maintenance, utility systems, engineering drawings, root cause analysis. Skills: Problem-solving, preventive maintenance planning, documentation, vendor coordination. Key Competencies Strong technical knowledge of mechanical equipment used in pharma API plants. Ability to work in a cross-functional team with Production, QA, EHS, and Stores. Hands-on troubleshooting skills. Awareness of cGMP and regulatory compliance. Safety-conscious mind set.
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