4089 Gmp Jobs - Page 37

About the Job Were changing the way people think about customer service, and we need your help! Were looking for a Quality Assurance Team Lead to be responsible for recording, reviewing and evaluating production objectives and performance standards. Working with the Quality Team, this role involves ensuring we are in accordance with both our internal and client-partner metric goals, as well as identifying areas of opportunity, developing solution plans and coaching team members. As Quality Assurance Team Lead, You Will Manage administrative and reporting tasks associated with quality metrics Assist in providing actionable insights to our Operations Team and client-partners Partner with other...

Position Overview The Quality Head is the senior quality leader responsible and accountable for the overall Pune site Quality organization and contractors under the Quality Shared Services remit You will be the executive quality representative responsible for maintaining strict compliance with corporate, divisional, and regulatory quality system standards throughout the Pune Site, Global Quality Shared Services (GQSS), and associated and approved contractors This role reports to the AVP, Global Quality Management Systems, and is a member of the Global QMS Leadership team This role has significant and impactful responsibility, including executive quality leadership and decision making, regula...

About Company Comapany Name: Global calcium Pvt Ltd Location: Hosur, Tamil Nadu Role Summary : We are looking for skilled and experienced Project Technicians or Electricians with a minimum of 5 years of hands-on experience in the pharmaceutical industry . The candidate will support project execution, facility setup, maintenance, and electrical work as part of the Projects Department . Responsibilities Support the installation, commissioning, and qualification of new pharma equipment and utility systems. Carry out electrical and instrumentation work as per GMP and regulatory standards. Troubleshoot and repair electrical systems, instruments, control panels, and field devices. Read and interpr...

Purpose of Role- Responsible with inspection of incoming Raw & packaging material as per company norms and given SOPs to provide good quality product to customer. Responsibility- Water, ENA, Special Spirits, FF, BLEND, He/ She should ensure quality of Raw water as per company norms. He/ She should ensure the testing and quality of each batch of DM water Responsible for quality ENA, Special Spirits and Food Flavour. Responsible for quality of each batch of blend along with blending executive. Online Quality- Responsible for implementation of company SOP s and GMP s to maintain online quality of finished product. Responsible for start-up of bottling lines maintaining proper records in QC presc...

1.Preparation and standardize of volumetric solutions and maintaining its record. 2.Preparation of standard solutions and reagents and maintaining its record. 3.Water Analysis and data punching in SAP. 4.Analysis of Raw Material and Miscellaneous samples as per GTPs/ SOPs/ Spec & MOAs. 5.Raw materials Control sample management.

QC planning; GLP/QMS; chemist schedule/qualification Plan/review validation, calibration -AMC/CMC; audits; SOP/STP prep/training; COAs; stability loading/protocols prep Compile batch analysis data Indent materials Internal/External Mail coordination Required Candidate profile QC lead(GMP pharma—oral solids). GLP/QMS docu; ICH method & process validation HPLC/GC/UV, dissolution stability; OOS & CAPA-change control; monthly SOP/STP prep/review-mentoring, working std dev,

QC planning; GLP/QMS; chemist schedule/qualification Plan/review validation, calibration -AMC/CMC; audits; SOP/STP prep/training; COAs; stability loading/protocols prep Compile batch analysis data Indent materials Internal/External Mail coordination Required Candidate profile QC lead(GMP pharma—oral solids). GLP/QMS docu; ICH method & process validation HPLC/GC/UV, dissolution stability; OOS & CAPA-change control; monthly SOP/STP prep/review-mentoring, working std dev,

Roles and Responsibilities Conduct analytical testing using various instruments such as GC, HPLC, spectrophotometer, etc. Prepare samples for analysis and record results accurately. Maintain laboratory equipment and ensure proper functioning of instruments. Develop and validate new methods for analyzing chemicals and materials. Collaborate with cross-functional teams to resolve issues related to product quality. Should be familiar with software Caliber LIMS To analyze AMV, IP, CV, PV, FP stability products Worked in CGMP, GLP and GDP maintained environment in laboratory Who can Apply : Candidates with core Injectables experience

What you will do In this vital role you will conduct complex complaint investigations, resolves corrective actions with their effectiveness and resolves steps necessary to ensure the proper level of control for product in distribution. We are seeking a Specialist Quality Complaints Complaint Owner and member of the Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns and implements the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current...

What you will do In this vital role you will responsible for architecting, integrating, and deploying advanced MES solutions, with a focus on PAS|X MES platforms, seamless SAP ERP and Level 2 automation system interfaces, and leveraging the latest in cloud and digital technologies. As a member of Amgens Digital, Technology & Innovation organization, you will collaborate with global teams of engineers, automation specialists, IT professionals, and operations leadership to deliver robust, scalable, and compliant MES solutions. Your leadership will help drive the transformation of Amgens manufacturing network, ensuring operational excellence, compliance, and agility for future growth. Roles & R...

ABOUT AMGEN Roles & Responsibilities: Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, or prepare documents for public registries e.g. ClinicalTrials.gov Work closely with cross functional stakeholders to define redaction strategy and disclosure, lead review and approval, ensure submission readiness, and hand off for timely submission or posting Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting Communicate with team members or cross-functional stakeholders to resolve problems and escalate issues Record and maintain w...

The Senior Associate in Regulatory Affairs at Amgen plays an important role in ensuring that the company's products meet and maintain regulatory standards. They assist in preparing submissions for regulatory agencies, keep updated on changes in regulatory legislation, and guide various teams within the company to ensure compliance with applicable regulations. R egulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. The Regulatory Compliance team is...

The primary responsibility of this role is to perform quality control reviews of of Amgens Periodic Aggregate Safety Reports (PASR) e.g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e.g. Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. The QC Reviewer will ensure accuracy, consistency, and compliance with regulatory and company standards. This role supports the end-to-end writing and documentation process and ensures t...

Responsible for ensuring that all packaging materials (cartons, labels, bottles, caps, laminates, pouches) meet company quality standards. Inspection, testing, documentation, supplier coordination, and continuous improvement in packaging quality. Required Candidate profile Familiarity with testing equipment like bursting strength tester, GSM tester, MFI tester, seal strength tester. Ensure compliance with GMP, ISO, HACCP, and company QA policies. Job Location- Jaipur

Department Name: Enterprise Engineering and Analytics (EEA) Role GCF: 4 Job Family: Software Development Engineer-Test I I Role Description: We seek a skilled Validation Lead to oversee and manage validation activities for data platforms and solutions . As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data and analytics products follow the required validation processes, documentation, and comply with Amgens standard operating procedures, policies, and guidelines . Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant . Roles & R...

What you will do In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. In this position you will supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation. This individual will actively participate during all phases of qualification/validation of computerized systems: evaluate projects; provide guidance and technical information to others (lead qualification/validation activities); determine and establish requirements for quali...

The AIN QA Technical Specialist plays a critical role in advancing Quality Assurance initiatives across the Quality Operations Network, with a particular focus on Management Review, Inspections and Compliance, and Technical Writing & Data Analytics. This role provides operational support, technical leadership, and cross-functional collaboration to ensure compliance, continuous improvement, and data-driven decision making in support of the Quality Management System (QMS). The position will be responsible for tasks including the key responsibilities documented below and other technical quality-related job functions. This candidate will primarily work during regular working hours (9 AM 6 PM loc...

Role & responsibilities 1. To convert sales forecast into timely product dispatches by proper planning, scheduling, and resource utilization 2. To coordinate with the supply chain department for timely dispatches, maintaining standard storage conditions, and arranging 3. The necessary raw materials, chemicals, fuels, etc. for production requirements 4. Responsible for the overall quality of the Product and by-products 5. To monitor and control the Engineering department. on all maintenance-related activities to enhance reliability & productivity. 6. To support the Engineering Department on modifications, expansions to meet business requirements. 7. To guide & execute standards in plant cover...

Roles and Responsibilities Review documents from various departments to compile regulatory submission. Oversee drug master file for submission to regulatory authorities, including updates, amendments, and revisions as required. Draft both the applicant and restricted parts of DMF s to ensure regulatory complience. Coordinate with CFT to address deficiency and feedback from RA and customers. Conduct CFT meetings to ensure timely responses to regulatory deficencies and customer inquires. Provide regulatory guidance to product development teams and attend technology transfer meetings to support compliance. Respond promptly to technical queries from regulatory bodies and customers.

Roles & Responsibilities: The ideal candidate will be accustomed to working in Web applications and should be actively involved in various types of testing such as Functional, System, Stress, Performance, Integration, Regression, and Beta. Develop and maintain comprehensive test plans for 3DExperience platform modules and application Involve actively in release planning and estimate test efforts Test in an Agile development environment, analyze and communicate test results to team and manager Develop validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Stay upd...

What you will do This strategic leadership role is accountable for building, managing, and evolving the global MES COE, overseeing MES and adjacent systems deployments, lifecycle management, and governance for all manufacturing sites across Amgens network. As the Sr Manager, you will direct a high-performing team of MES engineers, and technical specialists, ensuring the effective delivery and continuous improvement of MES solutions. You will partner with cross-functional leaders in Digital, Technology & Innovation, Operations, Quality, IT, and Automation to drive Amgens NextGen MES strategyfrom vision through executionsupporting seamless integration with SAP, automation, cloud, and data plat...

Walk-in drive: Senior Chemist / Junior Research Associate - HPLC Analytical Method Validations Work Location: Hyderabad Eligibility: Must have 1 to 3 Years of experience in Analytical Method Validations by using HPLC for Formulation products. M.Sc. / M-Pharmacy or Equivalent Qualification. Job Description : Analytical method validations and method transfer as per cGMP requirements for drug products. Strong experience in handling various analytical instruments like HPLC, UPLC, UV and Dissolution USP type-I and II and type-IV. Dissolution, Assay and Related Substances method validationand method development of finished products like Tablets, Capsules, Pellets, oral suspensions and Injectables ...

Position Summary: The AIN Specialist QA plays a critical role in supporting product disposition related tasks across the Amgen Quality Operations Network. The Specialist QA will leverage industry, technical, and quality systems knowledge to provide support of product expiry management processes, product complaints processes, disposition manager training, and fulfillment of disposition related data requests across the network. The position will be responsible for tasks including the key responsibilities documented below and other disposition related job functions. This candidate will primarily work during regular working hours (9 am 6 PM local time) to enable the business in delivering Amgens...

Title: Production chemist. Company : Sinterx pharma private limited Location : Valigonda, Choutuppal. Job Description for Production chemist. Searching for a reliable and highly skilled Production chemist (2 to 5 years) for an emerging Pharmaceutical Manufacturing company called Sinterx Pharma Pvt Ltd. Based out of Hyderabad, Sinterx is a rising company in the industry with deep relations with various high-stakes players in this industry and a dedicated and motivated team. Responsibilities: 1. Assist in the Preparation and execution of chemical Production Batches, following standard operating procedures (SOPs) to ensure accurate and consistent product quality. 2. Safely manage pyrophoric rea...

In this vital role you will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant. Roles & Responsibilities: The ideal candidate will be accustomed to working in Web applications and should be actively involved in various types of testing such as Functional, System, Stress, Performance, Integration, Regression, and Beta. Develop and maintain comprehensive test plans for 3DExperience platform modules and application Contribute actively to release planning and estimate test efforts Test in an Agile development environment, analyze and communicate test results to team and manager Develop validation ...