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8.0 - 12.0 years
0 Lacs
dehradun, uttarakhand
On-site
As a Site Manager- External Supply at our pharmaceutical company, you will play a crucial role in leading manufacturing and quality operations at external supply sites in India. Your primary responsibility will be to ensure that products are manufactured and supplied in compliance with Good Manufacturing Practices (GMP) and our Quality Management System (QMS). Collaboration with contract manufacturing organizations (CMOs) and cross-functional teams will be essential for the success of the operations. Your role will involve conducting gap analyses for GMP and Environmental Health and Safety (EHS) compliance, overseeing corrective actions, monitoring product quality, resolving quality-related issues, and ensuring timely product release. You will also support CMOs in continuous quality improvement, audit readiness, drive product lifecycle management, provide training on GMP and quality standards to site teams, and more. To qualify for this position, you should hold a Bachelor's degree in Pharmacy, Chemistry, Microbiology, or a related field and have a minimum of 8 years of experience in quality assurance or manufacturing within the pharmaceutical industry. Strong knowledge of GMP, QMS, and regulatory compliance is required, along with excellent communication and documentation skills. The preferred qualifications include experience with aseptic manufacturing and sterile dosage forms, knowledge of microbiological testing, proven ability to manage audits, strong problem-solving and decision-making skills, and the ability to work collaboratively with cross-functional teams. This is an on-site role based in India, and we are looking for proactive, detail-oriented individuals who are committed to continuous improvement. Join us in ensuring the quality and safety of our products while making a positive impact on patients" lives. We look forward to welcoming a dedicated professional like you to our team. If you are passionate about uniting science, technology, and talent to get ahead of disease together, and want to positively impact the health of billions of people, then GSK is the place for you. Our focus on preventing and treating disease with vaccines, specialty and general medicines, as well as investing in core therapeutic areas, makes us a global biopharma company with a special purpose. We are committed to creating an environment where our people can thrive, grow, and contribute to our mission. Please note that GSK does not accept referrals from employment businesses and/or agencies without prior written authorization. If you receive unsolicited emails or job advertisements not ending in gsk.com, please disregard them and inform us at askus@gsk.com.,
Posted 3 weeks ago
10.0 - 14.0 years
0 Lacs
karnataka
On-site
Are you an expert in aseptic manufacturing with a strong quality mindset and a desire to make a tangible impact on global health Novo Nordisk is seeking a dedicated Manufacturing Specialist to join our Global Contract Manufacturing Drug Product (GCM DP) team in Hyderabad, India. In this role, you'll be crucial in ensuring the high-quality production of life-saving insulin and GLP-1 products through our Contract Manufacturing Organizations (CMOs). Apply Now! As a Manufacturing Specialist (SME), you'll be the go-to expert driving Technology Transfer projects for commercial products, ensuring top-tier quality with our Contract Manufacturing Organizations (CMO) partners. Your key responsibilities will include leading cross-functional teams, ensuring seamless collaboration between Novo Nordisk as the sending Unit and Contract Manufacturing Organizations (CMOs) partners as the receiving Unit. You will also act as a mentor and support Contract Manufacturing Organizations (CMOs) to ensure Novo Nordisk products are manufactured to the highest quality standards. Additionally, you will provide training, share best practices, and review and approve validation documents to safeguard compliance while offering oversight and support during the planning and execution of validation and qualification activities. In this role, you will define, manage, and deliver on complex projects in collaboration with CMOs, Quality Assurance, and project managers. You will be responsible for driving problem-solving initiatives and providing scientific and technical solutions within tight project timelines. To qualify for this position, you should have a Bachelors/Masters degree in engineering and possess at least 10+ years of experience with relevant 5 years of manufacturing experience, especially in an international, multicultural environment. Expertise in aseptic manufacturing processes is non-negotiable. You should be capable of communicating naturally and effectively with stakeholders at all levels, adept at finding solutions, and motivating stakeholders to achieve ambitious goals. A strong mindset, a focus on continuous improvement, and keen attention to detail are essential for success in this role. You should demonstrate the ability to work independently with minimal supervision, a strong willingness to learn new skills, and the motivation and flexibility to thrive in a fast-paced, dynamic environment. The GCM DP RoW Projects department is dedicated to delivering life-saving insulin and GLP-1 to patients in regions such as Africa, India, the Middle East, and Asia. By partnering with CMOs in these areas, the department plays a pivotal role in improving the quality of life for patients living with diabetes and obesity. With a focus on Market Access initiatives, the team tailors projects to meet the unique requirements of each country, offering exciting growth opportunities. The department thrives on innovation and problem-solving, overcoming challenges and navigating complex regulatory landscapes to deliver insulin and GLP-1 on a global scale. Based in Hyderabad, India, you'll join a diverse and dynamic team committed to making a difference. Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. We are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. Our success relies on the joint potential and collaboration of our more than 72,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us! Together, we go further. Together, we're changing life. To submit your application, please upload your CV online (click on Apply and follow the instructions). The deadline for application submission is 8 August 2025. Novo Nordisk does not extend unsolicited employment offers and does not charge prospective employees with fees or make requests for funding as part of the recruitment process. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We are committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve, and communities we operate in. Together, we're life-changing.,
Posted 1 month ago
10.0 - 14.0 years
0 Lacs
karnataka
On-site
Are you an expert in aseptic manufacturing with a strong quality mindset and a desire to make a tangible impact on global health Novo Nordisk is seeking a dedicated Manufacturing Specialist to join our Global Contract Manufacturing Drug Product (GCM DP) team in Hyderabad, India. In this role, you'll be crucial in ensuring the high-quality production of life-saving insulin and GLP-1 products through our Contract Manufacturing Organizations (CMOs). Apply Now! As a Manufacturing Specialist (SME), you'll be the go-to expert driving Technology Transfer projects for commercial products, ensuring top-tier quality with our Contract Manufacturing Organizations (CMO) partners. Your key responsibilities will include leading cross-functional teams, ensuring seamless collaboration between Novo Nordisk as the sending Unit and Contract Manufacturing Organizations (CMCOs) partners as the receiving Unit. You will also act as a mentor and support Contract Manufacturing Organizations (CMOs) to ensure Novo Nordisk products are manufactured to the highest quality standards. Providing training, sharing best practices, and reviewing and approving validation documents to safeguard compliance will be crucial aspects of your role. Additionally, you will offer oversight and support during the planning and execution of validation and qualification activities. You will define, manage, and deliver on complex projects in collaboration with CMOs, Quality Assurance, and project managers. Driving problem-solving initiatives and providing scientific and technical solutions within tight project timelines will be key responsibilities. Qualifications for this role include a Bachelors or Masters degree in engineering, 10+ years of experience, and relevant 5 years of manufacturing experience, especially in an international, multicultural environment. Expertise in aseptic manufacturing processes is non-negotiable. The ideal candidate should be capable of communicating naturally and effectively with stakeholders at all levels, adept at finding solutions, and motivating stakeholders to achieve ambitious goals. Possessing a strong mindset, a focus on continuous improvement, and keen attention to detail is essential. Demonstrating the ability to work independently with minimal supervision, a strong willingness to learn new skills, and the motivation and flexibility to thrive in a fast-paced, dynamic environment are also important qualities. The GCM DP RoW Projects department is dedicated to delivering life-saving insulin and GLP-1 to patients in regions such as Africa, India, the Middle East, and Asia. By partnering with CMOs in these areas, the department plays a pivotal role in improving the quality of life for patients living with diabetes and obesity. With a focus on Market Access initiatives, the team tailors projects to meet the unique requirements of each country, offering exciting growth opportunities. The department thrives on innovation and problem-solving, overcoming challenges and navigating complex regulatory landscapes to deliver insulin and GLP-1 on a global scale. Based in Hyderabad, India, you'll join a diverse and dynamic team committed to making a difference. Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Join us and be part of a collective effort to change lives and go further together. To submit your application, please upload your CV online. Apply now and join us in making a difference.,
Posted 1 month ago
5.0 - 12.0 years
0 Lacs
karnataka
On-site
Are you an experienced aseptic manufacturing project manager with a strong technical background and a passion for making a direct impact on patients" lives Do you thrive in an international environment where cultural awareness is key to your success If so, this could be your dream role! Apply Now! As a Project Manager in Aseptic Manufacturing, you will lead and mentor cross-functional teams, including both Novo Nordisk and our Contract Manufacturing Organization (CMO) partners. You will ensure the seamless Technology Transfer and manufacturing of our commercial products, always upholding Novo Nordisk's stringent quality standards and adhering to cGMP and regulatory requirements. Your responsibilities will include leading and managing aseptic manufacturing projects, specifically leveraging your expertise in areas like Formulation/Compounding, Filling, Washing & Sterilizations, Environmental Monitoring, or Clean Utilities. Additionally, you will be developing and managing detailed project plans and timelines, and communicating effectively with steering groups and key stakeholders. Monitoring progress and proactively securing necessary resources, as well as developing project risk grids and identifying mitigation strategies with both Novo Nordisk and our Contract Manufacturing Organization (CMOs), will be vital aspects of your role. Qualifications required for this position include a Bachelors or Masters degree in engineering, 5-12 years of project management experience with a proven track record of successful project delivery in a highly regulated environment, especially internationally. Aseptic manufacturing experience is a must, and experience with Technology Transfer of biologics is a significant advantage. Professional experience balancing individual drive with effective stakeholder involvement, proficiency in project management software (e.g., MS Project, Smartsheet, Jira, or equivalent), and demonstrated fluency in written and spoken English is essential. GCM DP RoW Projects is a dedicated team committed to providing life-saving insulin and GLP-1 to patients in regions such as Africa, India, the Middle East, and Asia. By partnering with CMOs in these areas, the department strives to make a meaningful impact on the quality of life for patients living with diabetes and obesity. Our projects are tailored to meet the unique requirements of each country, offering exciting growth opportunities. With a steadfast commitment to innovation and problem-solving, we work to overcome challenges and navigate complex regulatory landscapes to deliver insulin and GLP-1 on a global scale. Join us in making a difference. Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 72,000 employees around the world. We recognise the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us! Together, we go further. Together, we're life-changing. To submit your application, please upload your CV online (click on Apply and follow the instructions). Deadline for application submission: 8 August 2025. Please note that instances of fraudulent job offers have been reported, purporting to be from Novo Nordisk and/or its affiliate companies. Novo Nordisk does not extend unsolicited employment offers and does not charge prospective employees for any reason.,
Posted 1 month ago
5.0 - 9.0 years
0 Lacs
indore, madhya pradesh
On-site
The role we are offering is for a Block Head to lead a key production block within our injectable manufacturing facility. Your responsibilities will include overseeing end-to-end manufacturing operations, managing a team of production staff, driving process optimization, ensuring regulatory audit readiness, maintaining compliance with cGMP standards, implementing changes, overseeing equipment and maintenance, coordinating cross-functionally, and managing inventory and resources. You should have a degree in Pharmacy, Engineering, or a related field, along with proven experience in sterile/injectable manufacturing. Strong leadership and team management skills are required, as well as knowledge of regulatory guidelines such as USFDA and EU standards. Hands-on experience with production equipment, QMS systems, and shop floor excellence tools is also desired. If you are ready to take on the challenge of leading a production block in a fast-paced, quality-driven environment, we are excited to hear from you.,
Posted 1 month ago
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