3 Gmp Requirements Jobs

As the Station Manager in Hyderabad for CRYOPDP, your primary mission is to ensure seamless operations, superior customer service, and optimal productivity at the Hyderabad branch. You will achieve this through effective leadership, operational excellence, and continuous improvement. Your responsibilities include overseeing day-to-day logistics, managing client relationships, and fostering a collaborative, high-performance team environment while upholding the highest standards of quality, safety, and profitability. Your key contributions will encompass various aspects of branch management, leadership, and development. You will be responsible for managing the entire branch, including overseeing staff, resources, facilities, and day-to-day activities. Additionally, you will control relationships with external agents, vendors, and service providers to uphold quality service standards and contractual obligations. Your role will also involve supporting domestic networks and site coordination for clinical trials and pharmaceutical activities. Client relationship management will be a crucial part of your responsibilities. You will focus on developing and maintaining relationships with existing and new clients, identifying growth opportunities, and expanding the client base. You will also be involved in business development, client follow-ups, and developing new agent networks. Temperature-controlled logistics and cold chain management will be a significant aspect of your role. You will monitor cold chain logistics, ensure quality control, handle temperature-sensitive shipments, and oversee the transportation of time-sensitive goods while complying with cold chain management standards. Operational audits, cost reduction initiatives, emergency shipment handling, and crisis management will also fall under your purview. Team and staff management will be another essential component of your role. You will be responsible for employee management, team supervision, shift and leave approvals, as well as employee recruitment, training, and development. Additionally, you will oversee HR coordination, compliance, and ensure that all operations comply with ISO standards. Financial management tasks will include cost management, petty cash management, quotation support, cost reduction initiatives, project management, pricing, and quotations. Facilities management, office maintenance, administrative support, and data management will also be part of your responsibilities. To excel in this role, you should possess a graduate or post-graduate degree with over 7 years of experience in the temperature-controlled logistics corporate sector. Proficiency in English, Hindi, and Telugu is required, with knowledge of other regional languages considered an advantage. Specific experience in temperature-controlled environments, operational and geographical knowledge, customs and airlines regulations, cold chain management, and supply chain understanding are crucial. Interpersonal skills, proficiency in Microsoft Office, effective communication, analytical skills, and the ability to lead a team are essential for success in this role.,

As an R&D Executive at VTC R&D, you are responsible for performing and overseeing all activities related to formulation and filling process development. Your duties include having a strong understanding of optimizing vaccine formulations, selecting stabilizers and excipients, as well as preparing adjuvants such as aluminium salts, Oil-In-Water emulsions, Liposome-based adjuvants with TLR agonists and saponin, and LNP formulation. You will also be involved in aseptic filling and Lyophilization cycle designing for new vaccine products and troubleshooting existing vaccines. In this role, you will execute clinical drug product manufacturing for clinical batches, plan and carry out media fill activities, and maintain R&D lab documents, equipment, and area qualifications in compliance with GMP requirements. Additionally, you will be responsible for preparing process validation and technology transfer protocols as per GMP requirements and collaborating with QA, QC, and Engineering departments for viral vaccine development activities. Ensuring proper hygiene and entry exit procedures in the formulation and filling section, preparing adjuvants, buffer solutions, and other materials, as well as coordinating with the central warehouse department for materials receipt and entry are also part of your responsibilities. You will supervise the preparation of disinfectant solutions, cleaning solutions, integrity testing of filters, and sanitization and disinfection activities in the R&D formulation department. As part of the QMS, you will handle deviations, MDD, investigations, observations, and ensure their timely closure. You will be involved in preparing standard operating procedures, batch manufacturing records, QRM, and protocols related to the R&D formulation and filling section. Moreover, you will supervise the washing, drying, packing, and sterilization of materials required for R&D development and GMP clinical batch preparation. Your role as an R&D Executive will be crucial in advancing vaccine development and ensuring compliance with quality standards and procedures.,

As the Section Head - Batch Release QA at Sun Pharmaceutical Industries Ltd, located in Halol (OSD), you will be responsible for overseeing IPQA activities and developing strategies in alignment with Sun Pharma Compliance, Product Quality Management objectives, and Regulatory requirements. Your role will involve planning and coordinating internal and external departmental support for quality assurance activities as per approved protocols and quality systems. You will be tasked with identifying and implementing solutions to enhance existing site quality assurance systems and processes, as well as managing batch release functions at the site. Your key responsibilities will include ensuring compliance with regulatory requirements related to products, processes, equipment, and release procedures, managing batch release activities for commercial dispatch, reviewing and approving investigations and CAPA, executing change control and risk assessment processes, and maintaining quality metrics reports as per specified timelines. You will also be responsible for coordinating with Quality Persons (QPs) and customers from different regions for batch release, managing technical agreements, overseeing warehouse and BSR operations, and handling retain sample storage, inspection, and life cycle management. To excel in this role, you are required to possess a minimum educational qualification of M.Sc/M.Pharm/B.Pharm along with at least 15 years of work experience. It is essential to have a strong knowledge of GxPs, cGMP, and other regulatory requirements, as well as demonstrate skills in planning, prioritization, collaboration, accountability, compliance, and customer service orientation. Additional attributes such as people connect, attention to detail, emotional control, effective communication, and problem-solving capabilities will be beneficial for your success in this position. In terms of the working environment, you will be working in both normal office settings and non-aseptic manufacturing/packaging environments. You should be prepared to work in areas with moderate to loud noise levels, comply with gowning requirements for controlled non-aseptic manufacturing areas, and wear personal protective equipment as necessary to ensure safety and compliance with GMP requirements.,