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15.0 - 19.0 years
0 Lacs
dewas, madhya pradesh
On-site
As the Microbiology Head at Sun Pharmaceutical Industries Ltd in Dewas, your primary responsibility will be to manage the overall site microbiology department. This includes overseeing sampling, testing, planning, qualifications, media fill program for sterile manufacturing, compliance, and upgrades of facilities and procedures. Your role will involve conducting effective reviews of the team and portfolio, providing direction and guidance to ensure product quality is maintained in adherence to GMP norms and timelines. You will be required to provide leadership and direction to achieve quality goals, organize timely microbiological sampling, testing, and release of raw materials, finished products, stability samples, water and utility samples, as well as environmental monitoring of various areas within the manufacturing blocks and warehouses. Additionally, you will be responsible for managing microbial cultures, laboratory investigations, and participating in internal, external, and regulatory inspections of microbiology operations. Ensuring compliance with GxPs, cGMPs, and safety standards in the microbiology laboratory is crucial, along with training microbiologists on techniques, aseptic practices, quality management skills, and personnel development. You will also be involved in preparing annual budgets for the microbiology section and liaising with the Corporate Micro team to implement microbial risk assessment programs. The ideal candidate for this position should be a Microbiology Graduate or equivalent with a minimum of 15 years of experience in microbiology work. Key success attributes include knowledge of regulatory requirements, compliance, collaboration, accountability, customer service orientation, planning, prioritization, attention to detail, people connect, emotional control, effective communication, and problem-solving skills. Additional responsibilities may be assigned as required.,
Posted 3 days ago
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 1 week ago
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