5.0 - 9.0 years

0 Lacs

ahmedabad, gujarat

On-site

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.,

Posted 1 day ago

Apply

SECTION HEAD - BATCH RELEASE Sun Pharmaceutical Industries Ltd

15.0 - 19.0 years

0 Lacs

halol, gujarat

On-site

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.,

Posted 2 days ago

Apply

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.