39 Eu Jobs - Page 2

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.)

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 working in formulations may skip this job post.

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/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

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

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 Skills Strong understanding of global patent laws (US, EU, India, etc.). Experience with patent prosecution, litigation support, and FTO analysis. Ability to manage multiple priorities in a fast-paced environment. Excellent communication and interpersonal skills, with the ability to collaborate across teams. High integrity, professionalism, and ethical conduct. Overview This position is responsible for managing all aspects of Intellectual Property Rights (IPR) within the pharmaceutical business. The role includes developing and implementing IP strategies, patent portfolio management, conducting freedom-to-operate (FTO) analyses, and supporting R&D and business development with IP-related inputs. The position plays a key role in safeguarding the company's innovations and maximizing the commercial value of its IP assets. Key Responsibilities: I. Lead patent strategy development to support R&D and commercial objectives, ensuring alignment with global IP laws and business goals. II. Oversee patent drafting, filing, prosecution, and lifecycle management for new chemical entities, formulations, processes, and other innovations. III. Conduct detailed patent landscape and freedom-to-operate (FTO) analyses to guide product development and market entry plans. IV. Collaborate with R&D and formulation teams to identify inventions and manage invention disclosure processes. V. Manage oppositions, revocations, and patent litigations in coordination with external legal counsel and internal stakeholders. VI. Monitor competitor IP filings and proactively develop strategies for challenging or circumventing third-party patents. VII. Support business development activities through IP due diligence, contract reviews, and licensing assessments. VIII. Ensure global IP compliance and manage relationships with patent attorneys and regulatory experts across multiple markets. IX. Develop and deliver training programs to increase IP awareness among scientific and commercial teams. X. Contribute to regulatory strategy by advising on exclusivity periods, patent linkage issues, and IP-related regulatory pathways (e.g., Paragraph IV filings, data exclusivity).

Compilation, review & submission of regulatory documents with USFDA, EU, Canada for Ophthalmic preparation Evaluation of analytical documents–specifications for ophthalmic drug products, method validation Preparation & submission of variation filings