2 Process Investigations Jobs

As the individual responsible for the overall operations and activities of the Drug Product Plant, you will play a crucial role in ensuring the production and manpower planning for the plant. Your primary focus will be to oversee that products are manufactured and stored in compliance with approved procedures and documentation to maintain the highest quality standards. It will be your responsibility to review and ensure the execution of Batch Production Records in accordance with cGMP requirements. You will also be in charge of ensuring the qualification of equipment and instruments is carried out as scheduled and that product validations are conducted as per regulatory requirements. Monitoring and maintaining the minimum stock of consumables, logbooks, and status labels will be part of your daily tasks. You will need to coordinate with various service departments for production-related activities and attend GMP and safety trainings, implementing the outcomes in the workplace. Leading investigations of market complaints and quality incidents will be under your purview, including implementing effective CAPA against root causes. You will participate in management reviews on process performance and quality, aiming to drive continual improvements. Ensuring timely communication and escalation of quality issues to appropriate management levels will be vital to maintaining operational efficiency. Your role will also involve overseeing production activities in line with predefined procedures and guidelines, ensuring audit readiness, compliance with stipulated timelines, and adherence to legal, statutory, ISO, and OHSAS requirements. Identifying and evaluating risks, hazards, and environmental aspects, as well as developing and monitoring objectives and targets under ISO and OHSAS standards, will be essential responsibilities. In the absence or authorization of senior management, you will act as the department lead and must possess knowledge and hands-on experience in serialization, equipment qualification, regulatory audits, process investigations, deviations, customer complaints, as well as Lean and Six Sigma methodologies. **Qualifications:** - Qualification: B.Pharm / M.Pharm / M.Sc / B.Tech (Chemical) or equivalent - Experience: 15-20 years in Drug Product manufacturing/Formulation with exposure to regulatory environments - Strong leadership, communication, and people management skills - Proficiency in SAP and other manufacturing-related systems This role offers you the opportunity to be a key player in the Piramal Critical Care team, contributing to the vision of delivering critical care solutions globally and enabling sustainable growth for all stakeholders. You will be part of a dynamic environment that values inclusive growth, ethical practices, and equal employment opportunities based on merit. Piramal Critical Care (PCC) operates under Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, and is a significant global player in hospital generics, particularly in the production of Inhaled Anaesthetics. With a wide presence across the USA, Europe, and over 100 countries, PCC's product portfolio includes Inhalation Anaesthetics and therapies for spasticity management. As part of the PCC team, you will join a highly qualified workforce committed to expanding the global footprint in the critical care space. Together with Piramal Group, PCC actively engages in corporate social responsibility initiatives, collaborating with partner organizations to provide hope and resources to those in need and caring for the environment.,

Job Description : Responsible for the overall operations and activities of the Drug Product Plant. Oversee production and manpower planning for the Drug Product Plant. Ensure products are manufactured and stored as per approved procedures and documentation to maintain quality standards. Review and ensure execution of Batch Production Records (BFR, BPR, etc.) as per cGMP requirements. Ensure qualification of equipment and instruments is carried out as per schedule. Ensure product validations are conducted in line with regulatory requirements. Monitor and maintain minimum stock of consumables, logbooks, and status labels. Ensure preventive maintenance of equipment as per the defined schedule. Coordinate with service departments (QA, QC, Stores, SCM, EHS, E&M) for production-related activities. Attend GMP and safety trainings and implement training outcomes at the workplace. Ensure initial and continual training of department personnel is conducted and updated as per need. Oversee production-related inputs in SAP and ensure timely FG transfers. Lead investigations of market complaints and quality incidents. Investigate market complaints, deviations, and quality incidents, and implement effective CAPA against root causes. Participate in management reviews on process performance, quality, and drive continual improvements. Ensure timely and effective communication and escalation of quality issues to the appropriate management levels. Ensure production activities are executed as per predefined procedures and cGMP guidelines. Ensure audit readiness and compliance with stipulated timelines. Ensure compliance with legal, statutory, ISO, and OHSAS requirements. Identify and evaluate risks, hazards, and environmental aspects and review them periodically. Develop and monitor objectives and targets under ISO and OHSAS standards. Identify SHE training needs and ensure awareness and competence among department personnel. Act as department lead in the absence or authorization of senior management. Possess knowledge and hands-on experience in serialization. Possess knowledge and hands-on experience in equipment qualification. Demonstrated experience in independently handling regulatory audits. Hands-on experience in process investigations, deviations, and handling customer complaints. Knowledge and practical experience in Lean and Six Sigma methodologies.