294 Mhra Jobs - Page 8

General Summary: The Technical Support Specialist II is responsible for assisting our partners in diagnosing and resolving a partners product issues or questions. This role works in partnership with cross-functional teams to troubleshoot, resolve, and document issues, getting partners back on track to having a positive experience with our products. Essential Duties & Responsibilities: Provides support to cross-functional teams, with a high attention to detail Researches, analyzes, and documents findings May influence others within the Technical Support team through the explanation of facts, policies, and practices Interacts with partners to provide technical support via email, phone, chat, c...

Role : - Assistant Manager -Vendor Management QM. Location : Baddi Company : Fresenius Kabi Oncology Ltd. Key Responsibilities : To establish, execute and monitor compliance with the procedure for the selection, qualification, development, maintenance, and discontinuation of External Providers (Suppliers of materials & services). Collection of Supplier audit needs from FKOL sites and co-ordination with FK Global Sourcing teams to finalize Global Audit Planners. Track and Execute supplier audits assigned to FK-India as per the global planner and maintain up to date status in the global External Audit Management database, with regular updates to FK Global Sourcing team. Management QA activitie...

At Jacobs, you are tasked with challenging today to reinvent tomorrow by solving the world's most critical problems for thriving cities, resilient environments, mission-critical outcomes, operational advancement, scientific discovery, and cutting-edge manufacturing. Your impact is crucial as the world needs innovators and problem solvers who can turn challenges into greater opportunities. At Jacobs, we strive to push the limits of what's possible to make the world smarter, more connected, and more sustainable. In this role, you will be responsible for project delivery, design management, and project management. Your duties will include performing process engineering calculations such as heat...

The Group Leader -GCP QA (Clinical) at Syngene in Bangalore is responsible for managing the GCP QA auditors team and conducting various audits related to clinical research, process audits, Investigational Site audits, and safety database audits. The role involves assessing systems and practices to improve the GCP Quality System practices in alignment with the national and international GCP Quality System standards. The Group Leader must ensure compliance with quality (GxP) regulations and standards, making the facility audit-ready at all times. Key Responsibilities include: - Scheduling and conducting GCP QA audits to ensure compliance with regulatory requirements - Developing risk-based aud...

Long Description The person should have knowledge in Manufacturing equipments. He should have exposure in equipment’s such as FBE,Fette/KORSCH M/C & auto coater M/C. He should be able to handle equipment trouble shoot in Manufacturing department. He should have exposure in regulatory organization . He must have faced the USFDA ,MHRA & other regulatory audits. He should have the exposure in Caliber QAMS, elog, track wise ,SAP ,WIND ,CDAS & other software. He should have the exposure in process simplification/optimization ,SABA ,elog & SCADA. Competencies Education Graduation in Pharmacy Work Experience 3-6 years of experience in Fette compression machine

MISSION: The Case Specialist s job is to guarantee the optimised management of vigilance cases, using their scientific knowledge to enable a detailed analysis of the various files. He/she is the guarantor of the proper handling of a case, both from a regulatory and medical point of view, and in this respect masters the regulations in force. He/she must be able to validate all tasks related to the exploitation of cases, from their collection to their submission. In addition, he/she contributes to the smooth running of his/her Line Of Business. Main activities and technical skills: VIGILANCE CASES: Responsible for the Quality Control (QC) of vigilance cases. The QC includes fields: Coding acco...

" Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roor...

Urgent opening for Head QA with rich experience in MHRA site. Job location Chandigarh

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 6000 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 70 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary Responsible for Calibration, Thermal Mapping, SOPs and Formats preparation, Training co-ordination, online documentation and other Engineering GMP activities as needed or requested by the organization. ...

" Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roor...

" Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roor...

" Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roor...

As the Head of Quality Control at a leading Pharma MNC located in the Chandigarh Vicinity, you will be responsible for overseeing the quality control operations of highly regulated plants, specifically focusing on tablet/capsule/pallets/OSD products with a preference for injections. With over 20 years of experience in the industry, you will demonstrate a track record of excellence in maintaining MHRA and EUGMP profiles, along with multiple successful audit exposures. In the realm of Quality Assurance, you will showcase a deep understanding of the latest updates outlined in the ICH Q9 guidelines. For Quality Control, you will exhibit proficiency in the Updates related to ICH Q2R2 Analytical m...

The position of Head of Quality Assurance at a Leading Pharma MNC in Chandigarh Vicinity offers a competitive salary of up to 60 LPA. As a qualified candidate, you must possess over 20 years of experience in managing highly regulated plants, with a strong focus on Tablet/capsule/pallets/OSD products, and preferably injections as well. Your expertise should include an excellent MHRA and EUGMP Profile, along with a track record of multiple successful audit exposures. In the realm of Quality Assurance (QA), you are expected to be well-versed with the latest updates in ICH Q9 guidelines. Additionally, in Quality Control (QC), familiarity with Updates in ICH Q2R2 Analytical method validation is c...

Summary As a key resource within the Audit Management Office (AMO), this role ensures effective coordination and management of audits and inspections involving Data, Digital & IT (DD&IT) systems and processes. This includes supporting GxP audits (e. g. , GMP, GCP) and regulatory inspections by authorities such as FDA, EMA, MHRA and Swissmedic. The associate acts as a liaison, ensuring that relevant DD&IT subject matter experts address audit queries and deliver required documentation in a timely and accurate manner. Additionally, the role involves monitoring audit findings, overseeing remediations, and driving continuous improvement in audit readiness. About the Role MAJOR ACCOUNTABILITIES Go...

" Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roor...

About the Role: Grade Level (for internal use): 10 About the Role: EMEA Benefits Specialist The Team: The Global Benefits Team is a team of specialists that focuses on the Wellbeing and Benefits for our colleagues across the globe supporting 40+ countries. The Impact We invest in our success as a company by investing in our people. At S&P Global, we are committed to comprehensive, competitive benefits for our people. We provide benefits to support the health and financial needs of our people while helping make their working life experience more rewarding. This is a critical role that touches each of our colleagues and is critical to our People First Philosophy. This role supports the wellbei...

Preferred Education/ Qualification : B. Pharm/M. Pharm/M. Sc. Experience : 6 8 years of experience in Quality Assurance / MQA of sterile dosage manufacturing facility /Technology Transfer/Validation. Core Competencies : Technology Transfer of injectables Change Management process Risk assessments principles and tools Validation of manufacturing equipment s Drug Product Process validations Regulatory requirements Compendial Changes Technical Skills : Fundamental knowledge on manufacturing and Quality control activities, such as Solution preparation, filling, terminal sterilization, visual inspection, packing, in process sampling and analysis. Technical document review skills Knowledge in chan...

Creation/Revision/ Review of Specifications and Methods for Site Transfers and ANDAs Method Validation Protocol knowledge. Creation/Revision/ Review of Validation Repot for Drug substance, Excipients and Drug products. Initiate Change controls as necessary for: Method and specification revisions and stability Protocol Modules preparation for Drug substance and Drug product. Batch Analysis 32S/32P Reference Standards 32S/32P Characterization of Impurities 32S/32P Justification of Specification 32S/32P Facility Templates Stability Summary Reports for ACC, CRT & RT 5313 Reports (Dissolution Comparative test) QOS & Stability Overview - 32S/32P (If ANDA) To prepare vendor qualification report bas...

Requirement Experience in API Regulatory Affairs Routine job skill: Good conceptual, analytical, problem solving, reasoning and organizational skills. Should be change agile and have ability to work in highly matrixed environment. Attention to detail and accuracy required. Must be able to prioritize with independently/minimal guidance. Ability to handle multiple projects with good prioritization skills. Willingness to complete the work as per the committed timeline. Technical Skills: Sound understanding of drug development regulatory processes and requirements for defined market(s) and able to interpret and apply to projects. Ability to identify inconsistencies and deficiencies in technical ...

JOB SUMMARY: To ensure on handling of documents like analytical test procedures, specifications, standard operating procedures from initiation till implementation. To ensure quality control GLP related activities are performed as per SOP for calibration, qualification of instrument and equipment. To ensure sampling activities are performed as per SOP and sample integrity are maintained till analysis completion. To ensure working/reference standards are made available for analysis and timely qualification of standards within due date. To involve in investigations and to collaborate with cross function team for root cause determination and implementation of effective CAPA. To ensure safety and...

" Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roor...

Division Department Sub Department 1 Job Purpose Review the compliance level of site for deficiency response, prepare master validation protocol and report as per company quality policy and applicable regulatory guidelines Key Accountabilities (1/6) Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner Collect data from all SPOCs with respect to received work plan for review Escalate any delays in receiving response from unit with respect to work plan Review of collected data for work plan fulfilment Send data to HO for compilation of deficiency response Take follow up with HO to receive updated dossier...

" Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics Solid Dosage Formulations. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma which is subsidiary to Jubilant Pharmova Limited. Jubilant Generics have 2 manufacturing sitedat Roorkee, Uttarakhand and Salisbury, Maryland, USAengaged in manufacturing of Tablets and Capsules. The man...

Position: Site Head (Sr. Manager) - Production Location: Ranjangaon, Near Pune Reporting To: Head - Manufacturing Operations Industry: Pharmaceutical Manufacturing Experience: 15+ years in Plant leadership roles, preferably in pharmaceutical or manufacturing industries About Fresenius Kabi At Fresenius Kabi, we are driven by a commitment to improve the quality of lives: We are Committed to life. We strive for continuous innovation with our outstanding manufacturing capabilities, unique channel access, and customer proximity. With our four complementary business areas BioPharma, Pharma (primarily IV drugs and infusion therapy), Medical Nutrition, and MedTech; Fresenius Kabi plays a vital role...