6 Gmp Requirements Jobs

As a Project Planner at NNE, your role will involve being a part of a dynamic team of experienced professionals in the Project Management department. You will receive the necessary training and support to excel in planning large multi-disciplinary projects in the biotech and pharmaceutical field. Your responsibilities will include ensuring project planning activities are executed efficiently, adhering to project schedules, and implementing GMP requirements seamlessly. Additionally, you will contribute to the development and implementation of procedures and tools to enhance project execution within the department. Your daily tasks will revolve around creating project time schedules, identifying solutions to time constraints, advising project managers, evaluating progress reports, and providing schedule data for project reporting requirements. You will work collaboratively with a multi-disciplinary team, utilizing your expertise in project planning procedures and communication skills to drive successful project outcomes. To qualify for this role, you should have a minimum of 8-10 years of planning experience in an engineering or manufacturing company, proficiency in Primavera P6 and Microsoft Project, and a background in Quantity Surveying, Engineering, or Construction Management. Experience in the pharmaceutical, biotech, food, or chemical industries and the ability to handle multiple projects simultaneously are essential. Strong communication skills, both written and oral in English, and a structured approach to work are key attributes we are looking for in the ideal candidate. At NNE, we value individuals who are result-oriented, team players, and possess a flexible approach to work. If you are passionate about contributing to the design and construction of critical pharmaceutical facilities that impact millions of patients worldwide, we welcome you to apply for this position. Join our team of experts at NNE and be part of a work environment that fosters collaboration, innovation, and excellence in pharma engineering. If you believe you meet the qualifications and are ready to unleash your potential in a challenging yet rewarding role, we encourage you to apply before the deadline of 20th March 2025. For any inquiries or clarifications, please feel free to contact pvyn@nne.com or RHM@nne.com. We will be conducting interviews on an ongoing basis, and we look forward to the possibility of having you on our team at NNE India, Bangalore.,

The role of Site Quality Head within the Global Quality & Compliance business unit at Ahmednagar involves ensuring the supply of high-quality, GMP compliant products. Your main responsibilities will include defining operational strategies for quality system management, finalizing quality assurance and quality control goals, and ensuring alignment with Sun Pharma compliance standards and regulatory requirements. You will provide leadership to achieve all quality accountabilities for QA, QC, and Stability at the site. Proactively assessing quality issues, ensuring compliance with regulatory requirements, and tracking quality assurance/control metrics will be crucial aspects of your role. Your duties will also involve assuring individual compliance with regulatory requirements, GxPs, and department programs. This includes overseeing training, documentation, Standard Operating Procedures, and adherence to Sun Pharma Global Quality Policies, Standards, and Procedures. You will be responsible for designing, implementing, and ensuring compliance with quality-related SOPs, Policies, Standards, and Quality systems at the site. Implementing continuous improvement initiatives, ensuring resource availability, and facilitating harmonization of Quality Systems and procedures will be key focus areas. Additionally, you will lead investigations into market complaints, failures, and deviations, ensuring timely implementation of corrective and preventive actions. Monitoring industry trends, preparing quality budgets and headcount projections, and managing expenditures to budget are also part of your responsibilities. Ensuring compliance with regulatory requirements on product, process, and release procedures, as well as collaborating effectively with other Sun Pharma sites and functions, will be essential. Furthermore, you will be expected to follow the EHS policy, laboratory standard operating procedures, and maintain compliance with GMP requirements. The educational qualification required for this role is M.Sc / B.Pharm / M.Pharm, and the ideal candidate should have 18 to 22 years of work experience.,

As a Senior Regulatory Associate (CMC) at Syneos Health, you will play a crucial role in ensuring regulatory compliance by leveraging your practical understanding of ICH guidelines, GMP requirements, and regional regulatory frameworks such as FDA and EMA. Your responsibilities will include preparing, compiling, reviewing, and submitting high-quality CMC dossiers for variations, renewals, annual reports, and RTQs. In this dynamic role, you will be expected to support change control assessment and impact assessments for global markets, as well as execute day-to-day tasks according to client processes and SOPs to build high-quality global CMC dossiers. Additionally, you will be involved in training and mentoring team members as needed based on project requirements. Your role will also entail liaising with cross-functional teams including Quality, Manufacturing, Analytical, etc., to gather necessary technical data and ensure regulatory consistency for global submissions. You should possess excellent written and verbal communication skills and be open to working in Cross-Cultural/Virtual teams, attending client meetings as required with relevant inputs. To qualify for this position, you should have a minimum of 4 years of experience in preparing, compiling, reviewing, and submitting high-quality CMC dossiers for variations, preferably with a Masters degree in pharmaceutical sciences or other life sciences. The ability to work independently, manage multiple priorities in a fast-paced consulting environment, and experience with RIMS/Veeva Vault for submission management are essential qualifications for this role. Syneos Health is committed to developing its employees through career development and progression, supportive line management, technical and therapeutic area training, peer recognition, and a total rewards program. Join us in our mission to accelerate the delivery of therapies and make a difference in the lives of patients worldwide. Find out more about Syneos Health and our impactful work at http://www.syneoshealth.com.,

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.,