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10.0 - 14.0 years
0 Lacs
dewas, madhya pradesh
On-site
You will be joining Sun Pharmaceutical Industries Ltd as a QA Sterile Manager in the Quality Assurance department. Your role will involve managing the Quality Assurance functions of the Manufacturing Block P. As the Manager-I, you are required to hold an M.Sc. degree in Biotechnology, Microbiology, or Chemistry with over 10 years of experience in the field. Your responsibilities will include ensuring that manufacturing and packing processes are carried out per SOPs and cGMP regulations. You will be responsible for certifying batch production records, releasing/rejecting batches after thorough reviews, and tracking the QMS system. It will be your duty to investigate complaints, deviations, OOS, and stability failures, ensuring timely closure and contamination controls as per the contamination controls strategy. You will collaborate with various departments like planning, QC, Regulatory Affairs, Manufacturing, and Engineering to ensure batches are released on time. Your role will involve participating in self-audits, aseptic simulations, and identifying opportunities for continuous improvement in compliance, process clarity, and operational efficiency. Reviewing and approving various documents such as master batch production records, protocols, reports, and stability sample management will also be part of your responsibilities. Additionally, you will manage activities related to IPQA, line clearance, in-process checks, calibration records, artwork approval, and provide training to support staff. Your focus will be on enhancing knowledge of cGMPs, improving practices, complying with the Quality Policy, and enhancing systems and procedures to ensure the quality of products manufactured and delivered meets the required standards.,
Posted 1 week ago
5.0 - 9.0 years
0 Lacs
delhi
On-site
Are you looking for a new challenge Here's what we offer you! As an Application Specialist PostPress at our company, you will be responsible for providing technical service and support to both internal and external customers in installations and servicing of equipment. You will need to have a BE/B.Tech/Diploma in Printing technology, along with 5 to 8 years of relevant work experience in the Graphic Art Industry. A very good knowledge of Post press printing machineries is mandatory, and excellent business communication skills in English & Hindi are required. You should also be willing to travel extensively across India. Your responsibilities will include understanding requirements and advising technical solutions, escalating technical issues when needed, adhering to service policies and guidelines, providing support to field team technicians, managing customer complaints, preparing accurate quotations, overseeing major repairs, and ensuring customer satisfaction. You will also be involved in planning installations, updating technical information, and recommending service tools to optimize operational efficiency. At HEIDELBERG, we believe in innovation and tradition, shaping the future together for over 170 years. We are looking for future employees who can actively contribute to shaping the HEIDELBERG of tomorrow. If you are someone who can turn ideas into reality, take initiative, and work collaboratively in a team, then join us in creating a successful future. We value individuals who take action and lead others towards success. Even if you do not meet all the requirements listed, we still encourage you to apply. Your salary at HEIDELBERG will be attractive, your work environment modern, and your social benefits excellent. Join us, utilize your skills, develop your potentials through our personal development programs, and be a part of actively shaping a sustainable and successful future.,
Posted 2 weeks ago
4.0 - 8.0 years
0 Lacs
pune, maharashtra
On-site
You should have 4 to 8 years of experience in the relevant field, with hands-on experience in setting up Test Labs. Your responsibilities will include Procurement and PO releasing for components, lab equipment, tools, and jigs. You will be required to run Equipment and Tools tests, validate Test methods, and support Design verification & IQ/OQ/PQ for medical Equipments and V&V Lab. Additionally, you will be responsible for Lab Equipment Calibration and maintaining the Calibration database. Collaborating with the team on product failure, defect management, and CAPA investigation will be part of your role. Ensuring QMS conformance, meeting quality policy and objectives as per organizational guidelines is crucial. You will be involved in Prototype assemblies, Testing Activities, inspection of Proto parts, and maintenance of custom tools part and fixture design. Supporting Instruments/Tools and Consumable managements, as well as tracking Logistics of parts, will also be part of your duties. Troubleshooting equipments and systems, performing RCA, working with External service team for Installation reports, service reports, and other technical service-related documents are also expected from you. Lastly, you will be required to conduct on-job medical equipment assessment, repair, and quality assurance checks for engineers.,
Posted 2 weeks ago
10.0 - 15.0 years
10 - 17 Lacs
Ahmedabad
Work from Office
Role & responsibilities: To enhance the quality system by imparting cGMP knowledge and updating regulatory requirements to the sites. To provide new regulatory guidance and technical documents to the site. To maintain a quality intelligence database and inform the concerned site about current regulatory requirements, updates and changes as and when required. To prepare corporate quality policy, standard practices, and corporate directives for system harmonization across all sites. To evaluate and ensure continual improvement of the quality management system. To verify policy implementation at the site and extend the identified gaps to the site for compliance. To review and evaluate regulatory guidelines, other company 483s, warning letters and inspection reports as per current regulatory requirements and extend identified gaps into quality intelligence portal to sites for compliance. To inform the Zydus family about new quality issues, current regulatory inspection trends, forecasts and best possible practices. To impart policy training to the site as and when required. To initiate corporate change controls for preparation and revision of quality policies. To review, verify and monitor the implementation of extended Global CAPA, Policy implementation observations and quality intelligence observations at sites. To perform any other activity assigned by HOD, as and when required. Preferred candidate profile: 2 Vacancies: one is for QA OSD background and second is for QA Injectable background. Candidate must be from pharma QA (OSD or Injectable) background. Must have Good communication skill, drafting skill and interpersonal skills. Must ready to travel to site location for inspections and audit. Must be ready to work at Ahmedabad location.
Posted 1 month ago
5.0 - 9.0 years
0 Lacs
karnataka
On-site
Marlabs Innovations Pvt Ltd is seeking a Senior Software Engineer - SAP Basis with 5-8 years of experience. The ideal candidate should have a Bachelor's degree in Computer Science, Information Systems, or a related field, or equivalent experience. You should be able to work in a virtual environment, effectively prioritize tasks in a high-pressure setting, and demonstrate autonomy and self-motivation in a fast-paced and complex work environment. It is essential to have the ability to meet SLA timelines, stay updated with relevant SOPs, and possess an analytical mind with problem-solving skills. As a Senior Software Engineer - SAP Basis, you will be responsible for providing L2/L3 level support for multiple SAP systems like ECC, BW, XI/PI, SCM, SOLMAN, BOBJ, EP, GRC, HCM, and non-SAP components. Your role will involve overseeing all aspects of Application Life Cycle Management, database administration with a focus on ORACLE, MS SQL, HANA DB, as well as maintaining the integrity of SAP and non-SAP environments. You will also be required to provide technical support for SAP issues, perform system refreshes, client copies, server migrations, and create/maintain documentation related to SAP Basis operations. Moreover, you will need to liaise with cross-functional teams and business users to drive continuous improvement initiatives, support Lean Sigma programs, and ensure compliance with the company's safety and quality policies. The position may require 10% global travel, occasional on-call work, and a willingness to work outside regular shift timings. Marlabs Innovations Pvt Ltd is an equal opportunity employer committed to fostering a diverse and inclusive workplace based on qualifications rather than characteristics protected by law. If you meet the requirements and are looking to join a dynamic team focused on digital solutions and data-driven outcomes, we encourage you to apply for the Senior Software Engineer - SAP Basis position at Marlabs Innovations Pvt Ltd.,
Posted 1 month ago
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