29 Eu Jobs

You are required to have a minimum of 2 years of experience using Tekla Structures specifically following the AISC standard. Your main responsibilities will include proficiency in utilizing Tekla software for steel detailing, as well as preparing and modifying detailed engineering drawings. It is essential to be familiar with industry standards such as AISC, NISD, CISC, OSHA, and EU. Strong communication and collaboration skills are necessary to effectively work with engineering teams. You should also possess the ability to manage documentation efficiently and respond promptly to any changes that may arise. While not mandatory, a Bachelor's degree in Civil Engineering or a related field would be advantageous. The job location is in Thane/Nasik.,

Key Requirements: Strong knowledge of KYC processes and Sanctions Screening frameworks Experience working with tools like Fircosoft, Bridger, World-Check , or similar Understanding of OFAC, EU, UN, and other global sanction lists Analytical mindset with excellent communication and documentation skills Role & responsibilities

Dear Candidate, Greeting of the day!! We have openings for Sanction Screening Experience: 3+ years No. of positions: 10+ Notice Period: Immediate Joiners Work mode: Hybrid ( Candidate will have to undergo 1-month initial training program (5 days) after Hybrid ) Virtual interview (02) Max Budget: 9.5 LPA Job Description: 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 combination Analyze false positive matches and make recommendations to the maintenance of the exception/internal list in a concise and detailed manner Analyze the rules that govern the automated systems of the watchlist, which identify any potential matches, understanding the business logic rules that create such matches Good knowledge of regulatory practices in AML, OFAC and sanctions and local laws Good analytical and logical reasoning skills Fully document all alerts, including supporting data, analysis as well as escalation or close recommendation rationale within the case management system in a timely manner and consistent with the firm's quality standards Build relationships with AML Investigations units and effectively communicate and transfer information for case investigations Collaborate with India and US colleagues to share processing and AML knowledge to enhance AML Investigation process flows As requested, participate in special projects, quality improvement initiatives and other similar exercises Required Qualifications & Capabilities Experience in compliance or related position Familiarity with the firm's internal systems and processes or similar processes at other institutions Self-starter, capable of working under minimum supervision Exceptional research and analytical skills with the ability to analyze large amounts of data, decipher higher risk attributes (transactional, geographical, product, customer type, etc.) and develop well-reasoned recommendations.

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 on name/country/address combination Analyze false positive matches and make recommendations to the maintenance of the exception/internal list in a concise and detailed manner Analyze the rules that govern the automated systems of the watchlist, which identify any potential matches, understanding the business logic rules that create such matches Good knowledge of regulatory practices in AML, OFAC and sanctions and local laws Good analytical and logical reasoning skills Fully document all alerts, including supporting data, analysis as well as escalation or close recommendation rationale within the case management system in a timely manner and consistent with the firm's quality standards Build relationships with AML Investigations units and effectively communicate and transfer information for case investigations Collaborate with India and US colleagues to share processing and AML knowledge to enhance AML Investigation process flows As requested, participate in special projects, quality improvement initiatives and other similar exercises Required Qualifications & Capabilities Preferred candidate profile

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 received from client/agency. Preparation of check list as per country specific requirements region. Review of documents like specifications/ MFC/ BMR/ PV/ Stability/ PDR/ DMF/ CoAs/Artworks and other quality related documents for their suitability for registration in MENA region. Co-ordinating for CoPP, GMP, License and other required documents/certificates legalization activity required for dossier compilation and registration. Archiving/Maintenance of the dossiers, renewal files and variation approvals along with supporting documents in regulatory data base. Identifying gaps in approved dossier, compiled and submit the post approval changes (Minor variations) to agent/agency. Filing of variations if any and registration renewals. Compilation and circulation of product approval package up on receipt of product approval/Minor variation approvals to concern departments. Maintaining the product status (Registered and Under registration) in excel sheet. Desired Candidate Profile Should Have Regulatory Affairs Relevant Formulation Experience Perks and Benefits

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 combination Analyze false positive matches and make recommendations to the maintenance of the exception/internal list in a concise and detailed manner. Role & responsibilities Preferred candidate profile Note :immediate joiner ,client :PWC , 1 Year of project Duration intrested candidates please share resumes @airpula.d@twsol.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/address combination • Analyze false positive matches and make recommendations to the maintenance of the exception/internal list in a concise and detailed manner • Analyze the rules that govern the automated systems of the watchlist, which identify any potential matches, understanding the business logic rules that create such matches • Good knowledge of regulatory practices in AML, OFAC and sanctions and local laws Good analytical and logical reasoning skills

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. You will handle tasks such as change control, deviations, CAPA, investigations, as well as document management including BMRs, BPRs, and master SOPs. Moreover, you will be responsible for preparing and reviewing protocols and reports as needed, overseeing the preparation, review, revision, control, and implementation of standard operating procedures in the sterile manufacturing department. Line clearance activities before commencing operations like manufacturing, sterilization, and filling are also part of your responsibilities, as well as checking records and logbooks related to various manufacturing processes. In addition to your defined job responsibilities, you may be required to perform other activities as instructed by the Head of Department (HOD) and provide training to subordinates, technicians, and operators. You must attend training sessions as per the schedule and ensure training aligns with the Training Needs Identification (TNI) process. Key Skills required for this role include adhering to Good Manufacturing Practices (GMP) and regulatory norms (USFDA, EU, WHO), accurately completing BMRs/BPRs, understanding deviations, change control, and CAPA, as well as the ability to inspire and guide others towards common goals while fostering a positive team environment. Qualifications: M.Sc. / B. Pharm / M.Pharm.,

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 Provider partnership or operating in a Full-Service setting, you will collaborate with a team of enthusiastic problem solvers who are committed to innovating and assisting our clients in achieving their objectives. At Syneos Health, we are agile and have a strong drive to expedite the delivery of therapies because we are deeply passionate about making a positive impact on people's lives. As part of our company, you will discover the significance of working in an environment where your contributions matter globally. We are dedicated to the growth and development of our employees through various means such as career advancement opportunities, supportive and engaged line management, technical and therapeutic training, peer recognition, and a comprehensive rewards program. Our commitment to the Total Self culture ensures that you can be your authentic self at work. This culture unites us globally and underscores our determination to prioritize the well-being of our employees. By fostering a diverse and inclusive workplace that values different perspectives, backgrounds, and cultures, we aim to create a sense of belonging for everyone. In your role, you will have the opportunity to engage with the vast experience of Syneos Health. Over the past five years, we have collaborated on 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and conducted over 200 studies across 73,000 sites involving 675,000+ trial patients. At Syneos Health, we encourage you to challenge the status quo, take initiative, and adapt to the highly competitive and dynamic environment we operate in. We are continuously evolving and striving to become the company that everyone desires to work for and that customers prefer to work with. Our ultimate goal is to harness the power of diverse thoughts, backgrounds, and perspectives to create a workplace where everyone feels included and valued. Please note that the tasks, duties, and responsibilities outlined in this job description are not exhaustive. The Company reserves the right to assign additional tasks, duties, and responsibilities at its discretion. Qualifications may vary based on equivalent experience, skills, and education. The Company will determine what constitutes equivalence to the qualifications mentioned. This job description does not create an employment contract and is intended to comply with all relevant legislation, including the EU Equality Directive and the Americans with Disabilities Act. Accommodations will be provided as necessary to enable employees or applicants to perform essential job functions.,

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 crossfunctional teams on standards, good documentation practices, and change control. Set up postmarket surveillance, complaint handling, and vigilance procedures ahead of launch. Preferred candidate profile Bachelors degree in engineering, Life Sciences, or related field; ISO13485 internalauditor certification preferred. 5 –10years’ QARA experience with ClassII (or higher) medical devices, ideally in a startup/smallteam environment. Demonstrated handson implementation of ISO13485 and compilation of CDSCO dossiers or FDA/CE submissions. Working knowledge of ISO14971, IEC62304, IEC60601, and Indian MDR2017; familiarity with EU MDR and 510(k) processes. Strong documentation skills, analytical mindset, and ability to translate regulatory language into actionable tasks for engineers. Selfstarter who thrives with minimal supervision and juggles multiple priorities in a fastmoving startup.

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 in the treatment of chronically and critically ill patients across various healthcare settings. For instance, over 70% of our IV drug units shipped in the US are on the Essential Medicines List of the US Food and Drug Administration, emphasizing the importance and impact of our products. All meaningful care comes down to people with the experience, expertise, and compassion to make a difference in the lives of those facing challenging situations. For us, care is a fundamental obligation, mission, and daily source of inspiration. It is the momentum that pushes us forward to help elevate the quality of life for both caregivers and those who need it most: critically and chronically ill patients. By providing essential medicines and technologies for infusion, transfusion, and medical nutrition, we are helping advance the future of healthcare, making it even more accessible, reliable, and in tune with current and future needs. Our principles: The Fresenius Principles form the basis of our company culture, with which we support our #FutureFresenius strategy. They describe what we stand for and how we operate, collaborate, approach challenges and make decisions as individual Fresenius employees and as a whole team. Role & responsibilities Confirm that production is carried out by appropriately qualified, experienced, and trained personnel. Ensure GMP-compliant operations across all manufacturing activities. Verify that manufacturing operations are clearly defined, systematically reviewed, and proven capable of consistently producing products of the required quality. Ensure manufacturing processes are properly validated. Provide assurance that critical process parameters are identified, controlled, and any changes are validated. Implement change control, event handling, and CAPA/action management processes in accordance with global Quality Management (QM) documents, monitor and trend accordingly. Maintain accurate records for equipment usage, calibration, maintenance, and repair including dates and responsible personnel. Oversee manufacturing equipment qualification, validation, and calibration programs. Ensure proper storage and handling of materials and products covering receipt, quarantine, sampling, storage, labeling, dispensing, processing, and packaging according to written procedures. Execute yield checks and quantity reconciliations to confirm no discrepancies exceed acceptable limits. Conduct in-process and environmental controls as required, ensuring accurate recording. Contribute to investigations of product quality defects. Control reprocessing or reworking of materials to prevent unauthorized use. Prevent cross-contamination and mix-ups during manufacturing, packaging, and labeling operations. Implement and monitor progress toward EHS policy objectives. Create, manage, and update documentation related to the Environmental Health & Management System. Maintain surveillance of compliance with legal and organizational requirements. Report EEHS performance metrics to top management. Conduct regular reviews of occupational risks and environmental aspects. Provide training and awareness to employees to minimize accidents and environmental impact. Liaise with corporate and global EEHS representatives regarding relevant issues. Conduct audits of the Environmental, Energy, and Health & Safety Management System Ensure realistic commitment to the production plan based on machine utilization and manpower availability. Collaborate with the Site Head to escalate and resolve key events affecting production, quality, and safety. Review and propose capital expenditure (CAPEX) and operational expenditure (OPEX) budgets. Lead and drive continuous improvement projects by identifying suitable opportunities and overseeing their implementation. Provide ongoing coaching and support to team members to build capability and strengthen performance. Proactively mitigate potential conflicts between internal and external stakeholders.

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+ crores but potential to increase it much more. The manufacturing divison employs 150 workers and staff. The company has continuous demand of its products and only needs to scale up its ability to produce to double its turnover in a short period. The product manufacturing processes include CNC machining, Pressing, Welding, Cutting and general machining. The ideal candidate must have Experience of 10 to 15 Year in Exports/International Marketing of Light engineering goods or Builder's Hardware. Must have Traveled and built contacts in western EUROPE/USA/Canada & Australia and other developed countries. He must good experience in handling Sales Team for Exports . Previous overseas travel for Global Marketing of light Enginnering goods/Builder's Hardware is essential for this position. Salary :- upto 40 LPA/Negotiable ( as per current salary). Age Limit: 44 Years

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 combination Analyze false positive matches and make recommendations to the maintenance of the exception/internal list in a concise and detailed manner Analyze the rules that govern the automated systems of the watchlist, which identify any potential matches, understanding the business logic rules that create such matches Good knowledge of regulatory practices in AML, OFAC and sanctions and local laws Good analytical and logical reasoning skills Fully document all alerts, including supporting data, analysis as well as escalation or close recommendation rationale within the case management system in a timely manner and consistent with the firm's quality standards Build relationships with AML Investigations units and effectively communicate and transfer information for case investigations Collaborate with India and US colleagues to share processing and AML knowledge to enhance AML Investigation process flows As requested, participate in special projects, quality improvement initiatives and other similar exercises Required Qualifications & Capabilities Experience in compliance or related position Familiarity with the firm's internal systems and processes or similar processes at other institutions Self-starter, capable of working under minimum supervision Exceptional research and analytical skills with the ability to analyze large amounts of data, decipher higher risk attributes (transactional, geographical, product, customer type, etc.) and develop well-reasoned recommendations Proficient in MS Office (Outlook/Word/Excel/PowerPoint) Strong documentation skills to clearly articulate alert disposition Adherence to controls and standard Professional & Educational Background Bachelors Degree in Commerce, Computer Science or equivalent is preferred. Full-time masters degree/equivalent is an added bonus. Additional Information Collaborating with leadership to deliver client engagements and associated outputs, supporting the team in day-to-day client management, project management, and the development of high-quality client deliverables. Emphasizing the ability to build solid and collaborative relationships with team members and also taking initiative to build relationships with client stakeholders. Excellent written and verbal communication skills

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/country/address combination Analyze false positive matches and make recommendations to the maintenance of the exception/internal list in a concise and detailed manner Analyze the rules that govern the automated systems of the watchlist, which identify any potential matches, understanding the business logic rules that create such matches Good knowledge of regulatory practices in AML, OFAC and sanctions and local laws Good analytical and logical reasoning skills Fully document all alerts, including supporting data, analysis as well as escalation or close recommendation rationale within the case management system in a timely manner and consistent with the firm's quality standards Build relationships with AML Investigations units and effectively communicate and transfer information for case investigations Collaborate with India and US colleagues to share processing and AML knowledge to enhance AML Investigation process flows As requested, participate in special projects, quality improvement initiatives and other similar exercises Required Qualifications & Capabilities Experience in compliance or related position Familiarity with the firm's internal systems and processes or similar processes at other institutions Self-starter, capable of working under minimum supervision Exceptional research and analytical skills with the ability to analyze large amounts of data, decipher higher risk attributes (transactional, geographical, product, customer type, etc.) and develop well-reasoned recommendations Proficient in MS Office (Outlook/Word/Excel/PowerPoint) Strong documentation skills to clearly articulate alert disposition Adherence to controls and standard Professional & Educational Background Bachelors Degree in Commerce, Computer Science or equivalent is preferred. Full-time masters degree/equivalent is an added bonus. Additional Information Collaborating with leadership to deliver client engagements and associated outputs, supporting the team in day-to-day client management, project management, and the development of high-quality client deliverables. Emphasizing the ability to build solid and collaborative relationships with team members and also taking initiative to build relationships with client stakeholders. Excellent written and verbal communication skills

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/country/address combination Analyze false positive matches and make recommendations to the maintenance of the exception/internal list in a concise and detailed manner Analyze the rules that govern the automated systems of the watchlist, which identify any potential matches, understanding the business logic rules that create such matches Good knowledge of regulatory practices in AML, OFAC and sanctions and local laws Good analytical and logical reasoning skills Fully document all alerts, including supporting data, analysis as well as escalation or close recommendation rationale within the case management system in a timely manner and consistent with the firm's quality standards Build relationships with AML Investigations units and effectively communicate and transfer information for case investigations Collaborate with India and US colleagues to share processing and AML knowledge to enhance AML Investigation process flows As requested, participate in special projects, quality improvement initiatives and other similar exercises Required Qualifications & Capabilities Experience in compliance or related position Familiarity with the firm's internal systems and processes or similar processes at other institutions Self-starter, capable of working under minimum supervision Exceptional research and analytical skills with the ability to analyze large amounts of data, decipher higher risk attributes (transactional, geographical, product, customer type, etc.) and develop well-reasoned recommendations Proficient in MS Office (Outlook/Word/Excel/PowerPoint) Strong documentation skills to clearly articulate alert disposition Adherence to controls and standard Professional & Educational Background Bachelors Degree in Commerce, Computer Science or equivalent is preferred. Full-time master’s degree/equivalent is an added bonus. Additional Information Collaborating with leadership to deliver client engagements and associated outputs, supporting the team in day-to-day client management, project management, and the development of high-quality client deliverables. Emphasizing the ability to build solid and collaborative relationships with team members and also taking initiative to build relationships with client stakeholders. Excellent written and verbal communication skills

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 audits and regulatory inspections by providing validation documentation and clarifications. Track and monitor validation schedules and ensure timely completion. Stay updated with latest regulatory trends, validation guidelines, and industry best practices (ICH Q8, Q9, Q10, Q12). Qualifications: B.Pharm / M.Pharm / B.Sc. / M.Sc. (Microbiology, Chemistry, Biotechnology) or related field. 25 years of relevant experience in validation within a pharmaceutical or healthcare manufacturing setup. Knowledge of cGMP, WHO, USFDA, EU, and other regulatory requirements. Key Skills: Sound knowledge of validation principles, risk assessment, and lifecycle approach. Proficiency in drafting validation protocols and technical documentation. Experience with computerized system validation (CSV) is an advantage. Good analytical, problem-solving, and organizational skills. Effective communication and ability to work in a team.

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 audits and regulatory inspections by providing validation documentation and clarifications. Track and monitor validation schedules and ensure timely completion. Stay updated with latest regulatory trends, validation guidelines, and industry best practices (ICH Q8, Q9, Q10, Q12). Qualifications: B.Pharm / M.Pharm / B.Sc. / M.Sc. (Microbiology, Chemistry, Biotechnology) or related field. 25 years of relevant experience in validation within a pharmaceutical or healthcare manufacturing setup. Knowledge of cGMP, WHO, USFDA, EU, and other regulatory requirements. Key Skills: Sound knowledge of validation principles, risk assessment, and lifecycle approach. Proficiency in drafting validation protocols and technical documentation. Experience with computerized system validation (CSV) is an advantage. Good analytical, problem-solving, and organizational skills. Effective communication and ability to work in a team.

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 audits and regulatory inspections by providing validation documentation and clarifications. Track and monitor validation schedules and ensure timely completion. Stay updated with latest regulatory trends, validation guidelines, and industry best practices (ICH Q8, Q9, Q10, Q12). Qualifications: B.Pharm / M.Pharm / B.Sc. / M.Sc. (Microbiology, Chemistry, Biotechnology) or related field. 25 years of relevant experience in validation within a pharmaceutical or healthcare manufacturing setup. Knowledge of cGMP, WHO, USFDA, EU, and other regulatory requirements. Key Skills: Sound knowledge of validation principles, risk assessment, and lifecycle approach. Proficiency in drafting validation protocols and technical documentation. Experience with computerized system validation (CSV) is an advantage. Good analytical, problem-solving, and organizational skills. Effective communication and ability to work in a team.

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 audits and regulatory inspections by providing validation documentation and clarifications. Track and monitor validation schedules and ensure timely completion. Stay updated with latest regulatory trends, validation guidelines, and industry best practices (ICH Q8, Q9, Q10, Q12). Qualifications: B.Pharm / M.Pharm / B.Sc. / M.Sc. (Microbiology, Chemistry, Biotechnology) or related field. 25 years of relevant experience in validation within a pharmaceutical or healthcare manufacturing setup. Knowledge of cGMP, WHO, USFDA, EU, and other regulatory requirements. Key Skills: Sound knowledge of validation principles, risk assessment, and lifecycle approach. Proficiency in drafting validation protocols and technical documentation. Experience with computerized system validation (CSV) is an advantage. Good analytical, problem-solving, and organizational skills. Effective communication and ability to work in a team.

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 determine false positives. Conducting complex research and investigations to confirm matches to global sanctions lists based on set guidelines. Releasing or escalating potential matches according to working instructions to the originating business unit and compliance department. Analyzing alerts for close match/exact match hits based on name/country/address combinations. Providing detailed recommendations for internal exception list maintenance based on false positive analysis. Analyzing automated system rules for watchlist matches to understand business logic rules. Good knowledge of regulatory practices in AML, OFAC, sanctions, and applicable local laws. Strong analytical and logical reasoning skills. Documenting all alerts including supporting data, analysis, and rationale for escalation or closure within the case management system. Building effective working relationships with AML Investigations units and facilitating information transfer for case investigations. Collaborating with India and US colleagues to enhance AML Investigation processes. Participating in special projects, quality improvement initiatives, and other exercises as requested. Required Qualifications & Capabilities : Prior experience in compliance or related functions. Familiarity with internal systems and processes of financial institutions (or similar). Strong self-starter attitude with the ability to work with minimal supervision. Exceptional research and analytical abilities, especially with large datasets to identify high-risk attributes. Proficiency in MS Office tools (Outlook, Word, Excel, PowerPoint). Strong documentation skills to articulate clear alert dispositions. Adherence to standard controls and compliance practices. Professional & Educational Background: Bachelors Degree in Commerce, Computer Science, or an equivalent discipline is preferred. Full-time master’s degree or equivalent will be an added advantage. Additional Information : Collaborating with leadership teams to deliver client engagements and outputs. Supporting client management, project management, and development of high-quality deliverables. Building strong collaborative relationships with team members and client stakeholders. Excellent written and verbal communication skills are critical.

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 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 combination Analyze false positive matches and make recommendations to the maintenance of the exception/internal list in a concise and detailed manner Analyze the rules that govern the automated systems of the watchlist, which identify any potential matches, understanding the business logic rules that create such matches Good knowledge of regulatory practices in AML, OFAC and sanctions and local laws Good analytical and logical reasoning skills Fully document all alerts, including supporting data, analysis as well as escalation or close recommendation rationale within the case management system in a timely manner and consistent with the firm's quality standards Build relationships with AML Investigations units and effectively communicate and transfer information for case investigations Collaborate with India and US colleagues to share processing and AML knowledge to enhance AML Investigation process flows As requested, participate in special projects, quality improvement initiatives and other similar exercises Required Qualifications & Capabilities Experience in compliance or related position Familiarity with the firm's internal systems and processes or similar processes at other institutions Self-starter, capable of working under minimum supervision Exceptional research and analytical skills with the ability to analyze large amounts of data, decipher higher risk attributes (transactional, geographical, product, customer type, etc.) and develop well-reasoned recommendations Proficient in MS Office (Outlook/Word/Excel/PowerPoint) Strong documentation skills to clearly articulate alert disposition Adherence to controls and standard Professional & Educational Background Bachelors Degree in Commerce, Computer Science or equivalent is preferred. Full-time masters degree/equivalent is an added bonus. Additional Information Collaborating with leadership to deliver client engagements and associated outputs, supporting the team in day-to-day client management, project management, and the development of high-quality client deliverables. Emphasizing the ability to build solid and collaborative relationships with team members and also taking initiative to build relationships with client stakeholders. Excellent written and verbal communication skills Interested Candidates Can share the resume "bindhumadhuri.b@twsol.com"

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 on name/country/address combination. Analyze false positive matches and make recommendations to the maintenance of the exception/internal list in a concise and detailed manner Analyze the rules that govern the automated systems of the watchlist, which identify any potential matches, understanding the business logic rules that create such matches Good knowledge of regulatory practices in AML, OFAC and sanctions and local laws Good analytical and logical reasoning skills Fully document all alerts, including supporting data, analysis as well as escalation or close recommendation rationale within the case management system in a timely manner and consistent with the firm's quality standards Build relationships with AML Investigations units and effectively communicate and transfer information for case investigations Collaborate with India and US colleagues to share processing and AML knowledge to enhance AML Investigation process flows As requested, participate in special projects, quality improvement initiatives and other similar exercises Required Qualifications & Capabilities Experience in compliance or related position Familiarity with the firm's internal systems and processes or similar processes at other institutions Self-starter, capable of working under minimum supervision Exceptional research and analytical skills with the ability to analyze large amounts of data, decipher higher risk attributes (transactional, geographical, product, customer type, etc.) and develop well-reasoned recommendations Proficient in MS Office (Outlook/Word/Excel/PowerPoint) Strong documentation skills to clearly articulate alert disposition Adherence to controls and standard

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 fluctuations. Manage supplier relationships, including regular communication, performance evaluations and issue resolution. Continuously evaluate and improve procurement practices, including identifying cost-saving opportunities and process enhancements. Stay updated on regulatory requirements and ensure compliance with applicable laws and regulations related to sourcing activities. To ensure timely communication with senior management with all MIS reports. *****

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 medical device QMS is required (e.g., ISO 13485, MDSAP, EU MDR, Risk Management etc.) Ensures that appropriate Quality Plans are made that include all stages product life cycle ,supports Quality Plan Validate key design inputs like : Usability, Reliability, Performance, Supportability, Manufacturability, Safety, Security, Privacy, Serviceability, Sustainability etc. Provides effective oversight of the execution of the Quality Plan, Risk Management activities, and all design related activities during the product/system life cycle Performs independent technical assessment on product quality performance and post-market product quality analysis Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required Act as a single point of contact (person assigned to project team) responsible t ensure that hardware design meets quality and compliance standards for every milestone etc.)