53 Eu Jobs - Page 2

Roles and Responsibilities Should Have Formulation Experience. Having vacancies in RoW (ASIA , MENA, LATAM, AFRICA) Regions Responsible for product registration RoW (ASIA , MENA, LATAM, AFRICA) Regions region Preparation, compilation and review of dossiers for region in eCTD/CTD/country specific format. Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities. Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. Responding to queries with in the time lines receive...

Screen individuals and entities against global sanction lists issued by OFAC, EU, UN and other international and government agencies Reviewing of individuals and business entities hit by high-risk scenarios Identify potential sanctions screening matches, review to identify false positives Carry out complex research/investigations to confirm whether the potential matches to global sanctions lists are actual matches according to laid down guidelines Release or escalate potential matches accordingly as stipulated in the working instruction to the originating business unit and relevant compliance department Analyze alerts to identify close match/exact match hits based on name/country/address com...

Screen individuals and entities against global sanction lists issued by OFAC, EU, UN and other international and government agencies • Reviewing of individuals and business entities hit by high-riskscenarios • Identify potential sanctions screening matches, review to identify false positives • Carry out complex research/investigations to confirm whether the potential matches to global sanctions lists are actual matches according to laid down guidelines • Release or escalate potential matches accordingly as stipulated in the working instruction to the originating business unit and relevant compliance department • Analyze alerts to identify close match/exact match hits based on name/country/ad...

Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.

You will be responsible for line clearance activities before commencing operations, following the preventive maintenance schedule of machines, cleaning and sanitizing the visual inspection and packing area, operating the machines, and filling the log of the general area according to SOP and work execution. Additionally, you must adhere to cGMP, GDP, and maintain discipline in the department, ensuring all employees follow the same standards. Your duties will also include ensuring that all equipment and lines are in a validated and calibrated status, preparing daily production reports, and creating production planning on a monthly and daily basis based on requirements and material availability...

As the Regulatory Manager (CMC, EU & Japan/China) at Syneos Health, you will be part of a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. Our focus is on translating clinical, medical affairs, and commercial insights into tangible outcomes that address the realities of the modern market. In our Clinical Development model, we prioritize placing the customer and the patient at the center of all our activities. We strive to simplify and streamline our processes, not only to enhance our interactions with clients but also to create a more conducive working environment for our employees. Whether you are engaged in a Functional Service P...

Role & responsibilities Architect and implement a lean, auditready ISO13485:2016 Quality Management System and drive certification. Own all designcontrol documentation (SRS, DHF, Risk Management File, DMR, Technical File, etc.) in collaboration with engineering teams. Define and execute regulatory strategies: first CDSCO (ClassII/III), then FDA 510(k), and EU MDR CE Mark. Prepare, review, and submit regulatory dossiers; interact with authorities and notified bodies. Plan and conduct internal audits, manage CAPA investigations, and lead continuousimprovement initiatives. Qualify and monitor suppliers/CMOs; establish incoming and inprocess quality controls and batchrelease records. Train cross...

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...

1) Designation :- Export Sales & marketing Head-Construction & Biulder's Hardware for International Marketing Qualification: Graduate/MBA or B.Tech/Diploma having travelled overseas . Be a ProvenTeam Leader. Our client is Ludhiana based engineering company with German Collaboration; led by an Engineering graduate and established in the city for more than 4 decades . The company has an overall turnover of 150+ crores and is run professionally and has an excellent track record in Exports & domestic market. The product and brand is known all across Europe and America. One of the divisions of the company is engaged in manufacturing metal parts for construction sector with a turnover of 15+ crore...

Screen individuals and entities against global sanction lists issued by OFAC, EU, UN and other international and government agencies Reviewing of individuals and business entities hit by high-riskscenarios Identify potential sanctions screening matches, review to identify false positives Carry out complex research/investigations to confirm whether the potential matches to global sanctions lists are actual matches according to laid down guidelines Release or escalate potential matches accordingly as stipulated in the working instruction to the originating business unit and relevant compliance department Analyze alerts to identify close match/exact match hits based on name/country/address comb...

Preferred Knowledge Screen individuals and entities against global sanction lists issued by OFAC, EU, UN and other international and government agencies Reviewing of individuals and business entities hit by high-risk scenarios Identify potential sanctions screening matches, review to identify false positives Carry out complex research/investigations to confirm whether the potential matches to global sanctions lists are actual matches according to laid down guidelines Release or escalate potential matches accordingly as stipulated in the working instruction to the originating business unit and relevant compliance department Analyze alerts to identify close match/exact match hits based on name...

Preferred Knowledge Screen individuals and entities against global sanction lists issued by OFAC, EU, UN and other international and government agencies Reviewing of individuals and business entities hit by high-risk scenarios Identify potential sanctions screening matches, review to identify false positives Carry out complex research/investigations to confirm whether the potential matches to global sanctions lists are actual matches according to laid down guidelines Release or escalate potential matches accordingly as stipulated in the working instruction to the originating business unit and relevant compliance department Analyze alerts to identify close match/exact match hits based on name...

Key Responsibilities: Prepare and execute validation protocols (IQ, OQ, PQ) for equipment, facilities, and utilities. Conduct cleaning validation and revalidation studies, including swab/rinse sampling and microbial testing coordination. Perform process validation (PV) activities for new and existing products. Coordinate with cross-functional teams (Production, QC, Engineering, R&D) for validation execution and troubleshooting. Review and update validation master plans (VMP), protocols, and reports as per regulatory requirements. Ensure calibration and qualification records are up to date and compliant. Maintain documentation in compliance with data integrity and ALCOA+ principles. Support a...

Key Responsibilities: Prepare and execute validation protocols (IQ, OQ, PQ) for equipment, facilities, and utilities. Conduct cleaning validation and revalidation studies, including swab/rinse sampling and microbial testing coordination. Perform process validation (PV) activities for new and existing products. Coordinate with cross-functional teams (Production, QC, Engineering, R&D) for validation execution and troubleshooting. Review and update validation master plans (VMP), protocols, and reports as per regulatory requirements. Ensure calibration and qualification records are up to date and compliant. Maintain documentation in compliance with data integrity and ALCOA+ principles. Support a...

Key Responsibilities: Prepare and execute validation protocols (IQ, OQ, PQ) for equipment, facilities, and utilities. Conduct cleaning validation and revalidation studies, including swab/rinse sampling and microbial testing coordination. Perform process validation (PV) activities for new and existing products. Coordinate with cross-functional teams (Production, QC, Engineering, R&D) for validation execution and troubleshooting. Review and update validation master plans (VMP), protocols, and reports as per regulatory requirements. Ensure calibration and qualification records are up to date and compliant. Maintain documentation in compliance with data integrity and ALCOA+ principles. Support a...

Key Responsibilities: Prepare and execute validation protocols (IQ, OQ, PQ) for equipment, facilities, and utilities. Conduct cleaning validation and revalidation studies, including swab/rinse sampling and microbial testing coordination. Perform process validation (PV) activities for new and existing products. Coordinate with cross-functional teams (Production, QC, Engineering, R&D) for validation execution and troubleshooting. Review and update validation master plans (VMP), protocols, and reports as per regulatory requirements. Ensure calibration and qualification records are up to date and compliant. Maintain documentation in compliance with data integrity and ALCOA+ principles. Support a...

Job Title: Sanction Screening Analyst Client: business consulting and services Location: Kolkata, West Bengal Job Description : We are seeking candidates with 3-5 years of experience in KYC Sanctions Screening (total overall work experience should not exceed 7 years) for our Kolkata office. Selected candidates must be available to work from the office and undergo a mandatory training program onsite. Preferred Knowledge : Screening individuals and entities against global sanction lists (OFAC, EU, UN, and other international/government agency lists). Reviewing individuals and business entities triggered by high-risk scenarios. Identifying potential sanctions screening matches and reviewing to ...

Role: Sanction Screening Location: Kolkata WFO 5 Days working General Shift Interested Candidates Can share the resume "bindhumadhuri.b@twsol.com" Please find the Below JD Preferred Knowledge Screen individuals and entities against global sanction lists issued by OFAC, EU, UN and other international and government agencies Reviewing of individuals and business entities hit by high-riskscenarios Identify potential sanctions screening matches, review to identify false positives Carry out complex research/investigations to confirm whether the potential matches to global sanctions lists are actual matches according to laid down guidelines Release or escalate potential matches accordingly as stip...

Role & responsibilities :- Screen individuals and entities against global sanction lists issued by OFAC, EU, UN and other international and government agencies. Reviewing of individuals and business entities hit by high-riskscenarios Identify potential sanctions screening matches, review to identify false positives Carry out complex research/investigations to confirm whether the potential matches to global sanctions lists are actual matches according to laid down guidelines Release or escalate potential matches accordingly as stipulated in the working instruction to the originating business unit and relevant compliance department Analyze alerts to identify close match/exact match hits based ...

Required JDs Developing and implementing procurement strategies and policies for cost optimization and enhancing supply chain efficiency. To ensure procurement of all herbal extracts and powders including raw materials, packing material and ingredients for herbal products. To monitor and forecast inventory, determining purchasing needs and identify costs. To develop new vendors and negotiate terms, prices, and conditions with them. Identifying, evaluating and selecting suppliers based on quality, reliability, cost-effectiveness and adherence to ethical and sustainability standards. Conducting market research and analysis to stay updated on industry trends, supplier capabilities and pricing f...

Job Description: Degree in mechanical engineering, electrical engineering, applied sciences or a related discipline; 10+ years of professional experience in medical device in Risk management , regulatory Quality systems EU MDR, US FDA and closely working R&D, Regulatory Affairs & design quality organizations Strong proven experience in simplifying/reviewing RMM,BRD, RMF, Trace matrix, DHFs, Design requirements, IFUs, Risk management , V&V activities etc. Expertise in interpreting & implementing various medical device standards and guidance's, such as IEC , ISO. Experience with systems for quality management, product development, and follow-up of procedures Knowledge and application of medica...

Designation : Executive / Sr Executive Department : Regulatory Affairs (API Industry only ) Qualification :M.Sc in Chemistry. Experience: 3 to 6 years. CTC : Rs 5 lacs to 7 lacs. Key Skills: DMF, NDA / ANDA dossiers, Regulatory Affairs. Filing of new Drug Master Files (DMFs) / Dossiers to respective countries (US, Europe, EDQM, Japan ) by compiling the documents as per CTD requirements. To interact and coordinate with R&T and manufacturing sites for all regulatory submissions (New filing and Amendments) and customer requirements. Maintaining life cycle of products as per the respective region wise requirements. Submission of Applicant Part to customers as per the requirement. Candidates work...

Experience in implementing eInvoicing solution for multiple countries - EU & Latam. Understand integration needs for various country specific authorities and agencies/ business partners. Understanding of BR DRC NFe and country specific localizations requirements. Simulate real time scenarios in SAP S/4 Hana with end to end process until tax authority. Understanding & hands-on on BTP platform. Experience on SAP DRC Cloud edition tool.

Preferred Knowledge Screen individuals and entities against global sanction lists issued by OFAC, EU, UN and other international and government agencies Reviewing of individuals and business entities hit by high-riskscenarios Identify potential sanctions screening matches, review to identify false positives Carry out complex research/investigations to confirm whether the potential matches to global sanctions lists are actual matches according to laid down guidelines Release or escalate potential matches accordingly as stipulated in the working instruction to the originating business unit and relevant compliance department Analyze alerts to identify close match/exact match hits based on name/...

Screen individuals and entities against global sanction lists issued by OFAC, EU, UN and other international and government agencies Reviewing of individuals and business entities hit by high-riskscenarios Identify potential sanctions screening matches, review to identify false positives Carry out complex research/investigations to confirm whether the potential matches to global sanctions lists are actual matches according to laid down guidelines Release or escalate potential matches accordingly as stipulated in the working instruction to the originating business unit and relevant compliance department Analyze alerts to identify close match/exact match hits based on name/country/address comb...