39 Eu Jobs

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com . Job Summary Responsible for auditing Apotex Enterprise sites, Apotex and Apotex Pharmachem Group of Companies suppliers encompassing audit scheduling, execution, reporting, follow-up and closure of the audits. Accountable for adhering to the requirements of the Apotexs Quality Manual, policies, procedures; and applying all regulatory standards such as ISO, Health Canada, FDA, EU/EMEA, MHRA, PIC/s, ANVISA and TGA, when conducting audits. Responsible for recommending audit system enhancements based on the learnings leveraging the existing system/field experience and collaborating with management to ensure continuous compliance, development & improvement of the Corporate Quality Audit program. Job Responsibilities Execute Corporate and supplier audits such as first GMP, routine, Targeted Technical Assessment (TTA) and For-Cause audits in accordance with Apotexs SOPs and current GMP regulations Adopt the best practices of Excellence in Partnership to develop and sustain effective relationships with Apotex sites, suppliers, contractors, and business partners Perform Due Diligence audits of potential new Apotex suppliers, generate reports and provide recommendations pertinent to suitability and sustainability of the quality and compliance of new suppliers. Propose remediation plans to mitigate risks that could be impeding the future stability of Apotex supply chain Liaise with Apotex Enterprise sites to evaluate the leading indicators such as QPIs prior to conducting site audits to ensure high risk areas are included as part of the site audit scope. Communicate potential non-compliance aspects of the audit outcome with the applicable site leadership team and escalate to Apotex Escalation Committee (AEC) as appropriate Research and compile all available supplier quality/procurement data such as complaints, investigations/deviations, recalls in Apotex systems (SAP, QMS TW, LIMS, etc.) and external systems (e.g. Health Canada, FDA, MHRA websites) to ensure high risk areas are included as part of the audit scope. Perform Risk Profiling of Apotex suppliers for Predictive Analytics to determine the audit frequencies based on the risks Compile precise, accurate and chronologically factual audit reports within the allotted time to enable meaningful review and approval of the audit reports Communicate the identified deficiencies and compliance risks to appropriate business stakeholders such as Global Active Pharmaceutical Ingredients (GAPI), External Manufacturing Quality (EMQ), Supplier Quality (SQ), Business Development (BD), Apotex Site Heads and Global Supply & Technical Operations (GSTO) Support the sites with developing and executing remediation actions to drive sustainable compliance to regulatory and Apotexs standards. Evaluate the appropriateness of proposed CAPAs and remediation plans, monitor the progress and evaluate the effectiveness of the CAPAs implemented Provide authoritative technical and regulatory guidance/direction to internal and external stakeholders pertinent to regulatory compliance Provide expert inspection and logistics support during inspections of Apotex sites by regulatory agencies and customers when requested Prepare, update and review proposed changes to SOPs Share knowledge, collaborate with auditors across the regions to enhance expertise in different disciplines and to mentor/coach new & existing auditors Review emerging/ever-changing regulatory landscape, standards & inspection trends to stay a step ahead of the regulators in protecting Apotexs interests internally and externally Fiscally responsible for spending in accordance with company policy and to accomplish budget targets favourable to plan Accountable for meeting individual and departmental monthly, quarterly and yearly audit metrics Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Job Requirements Education University degree in science or Regulatory affairs related program Background in pharmaceutical/chemical sector would be an asset Knowledge, Skills and Abilities Excellent knowledge in current good manufacturing regulations and standards as applicable to the pharmaceutical industry such as ISO, Health Canada, FDA, EU/EMEA, MHRA, PIC/s, ANVISA and TGA Expertise in at least one specific area: non-sterile manufacturing, sterile manufacturing, biopharmaceuticals, medical devices, API, excipients and intermediates is preferred. Ability to review and comprehend the requirements of ICH, WHO, EXCiPACT, ISO, IPEC, ISPE, etc. guidance documents Clear and concise written and verbal communication in Apotex s language of business Demonstrated organizational skills and strong attention to details Demonstrated ability to effectively manage multiple priorities in a fast-paced environment Demonstrated ability to exercise discretion, maturity, good judgement and maintain strict confidentiality when exposed to, and handling, sensitive and confidential information Work independently or in a team setting to achieve individual, departmental and organizational goals Advanced computer skills, including Microsoft Office Products Working knowledge with electronic Enterprise systems such as Quality Management System TrackWise (QMS TW), Systems Applications and Products (SAP) and Laboratory Information Management System (LIMS) would be an asset Experience Minimum 10 years of relevant experience in the Pharmaceutical industry with a minimum of 5 years spent in Quality operations, Quality Assurance and Quality Audits Working knowledge and/ or hands-on experience with the other Pharmaceutical Quality Systems would be an asset At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed. We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation. Show more Show less

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com. Job Summary Responsible for auditing Apotex Enterprise sites, Apotex and Apotex Pharmachem Group of Companies suppliers encompassing audit scheduling, execution, reporting, follow-up and closure of the audits. Accountable for adhering to the requirements of the Apotexs Quality Manual, policies, procedures; and applying all regulatory standards such as ISO, Health Canada, FDA, EU/EMEA, MHRA, PIC/s, ANVISA and TGA, when conducting audits. Responsible for recommending audit system enhancements based on the learnings leveraging the existing system/field experience and collaborating with management to ensure continuous compliance, development & improvement of the Corporate Quality Audit program. Job Responsibilities Execute Corporate and supplier audits such as first GMP, routine, Targeted Technical Assessment (TTA) and For-Cause audits in accordance with Apotexs SOPs and current GMP regulations Adopt the best practices of Excellence in Partnership to develop and sustain effective relationships with Apotex sites, suppliers, contractors, and business partners Perform Due Diligence audits of potential new Apotex suppliers, generate reports and provide recommendations pertinent to suitability and sustainability of the quality and compliance of new suppliers. Propose remediation plans to mitigate risks that could be impeding the future stability of Apotex supply chain Liaise with Apotex Enterprise sites to evaluate the leading indicators such as QPIs prior to conducting site audits to ensure high risk areas are included as part of the site audit scope. Communicate potential non-compliance aspects of the audit outcome with the applicable site leadership team and escalate to Apotex Escalation Committee (AEC) as appropriate Research and compile all available supplier quality/procurement data such as complaints, investigations/deviations, recalls in Apotex systems (SAP, QMS TW, LIMS, etc.) and external systems (e.g. Health Canada, FDA, MHRA websites) to ensure high risk areas are included as part of the audit scope. Perform Risk Profiling of Apotex suppliers for Predictive Analytics to determine the audit frequencies based on the risks Compile precise, accurate and chronologically factual audit reports within the allotted time to enable meaningful review and approval of the audit reports Communicate the identified deficiencies and compliance risks to appropriate business stakeholders such as Global Active Pharmaceutical Ingredients (GAPI), External Manufacturing Quality (EMQ), Supplier Quality (SQ), Business Development (BD), Apotex Site Heads and Global Supply & Technical Operations (GSTO) Support the sites with developing and executing remediation actions to drive sustainable compliance to regulatory and Apotexs standards. Evaluate the appropriateness of proposed CAPAs and remediation plans, monitor the progress and evaluate the effectiveness of the CAPAs implemented Provide authoritative technical and regulatory guidance/direction to internal and external stakeholders pertinent to regulatory compliance Provide expert inspection and logistics support during inspections of Apotex sites by regulatory agencies and customers when requested Prepare, update and review proposed changes to SOPs Share knowledge, collaborate with auditors across the regions to enhance expertise in different disciplines and to mentor/coach new & existing auditors Review emerging/ever-changing regulatory landscape, standards & inspection trends to stay a step ahead of the regulators in protecting Apotexs interests internally and externally Fiscally responsible for spending in accordance with company policy and to accomplish budget targets favourable to plan Accountable for meeting individual and departmental monthly, quarterly and yearly audit metrics Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Job Requirements Education University degree in science or Regulatory affairs related program Background in pharmaceutical/chemical sector would be an asset Knowledge, Skills and Abilities Excellent knowledge in current good manufacturing regulations and standards as applicable to the pharmaceutical industry such as ISO, Health Canada, FDA, EU/EMEA, MHRA, PIC/s, ANVISA and TGA Expertise in at least one specific area: non-sterile manufacturing, sterile manufacturing, biopharmaceuticals, medical devices, API, excipients and intermediates is preferred. Ability to review and comprehend the requirements of ICH, WHO, EXCiPACT, ISO, IPEC, ISPE, etc. guidance documents Clear and concise written and verbal communication in Apotex s language of business Demonstrated organizational skills and strong attention to details Demonstrated ability to effectively manage multiple priorities in a fast-paced environment Demonstrated ability to exercise discretion, maturity, good judgement and maintain strict confidentiality when exposed to, and handling, sensitive and confidential information Work independently or in a team setting to achieve individual, departmental and organizational goals Advanced computer skills, including Microsoft Office Products Working knowledge with electronic Enterprise systems such as Quality Management System TrackWise (QMS TW), Systems Applications and Products (SAP) and Laboratory Information Management System (LIMS) would be an asset Experience Minimum 10 years of relevant experience in the Pharmaceutical industry with a minimum of 5 years spent in Quality operations, Quality Assurance and Quality Audits Working knowledge and/ or hands-on experience with the other Pharmaceutical Quality Systems would be an asset At Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed. We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation. Show more Show less

• Business Development • New product identification for emerging markets through Identifying products from the current US & EU pipeline for extension. • Preparation of product wish list for respective region/country • Preparing and revising business cases for Pipeline and Under Registration products across Emerging Markets • Therapy analysis and portfolio analysis for identification of new products ideas. • Identifying new product ideas for in-licensing from wish-list, partner product lists, US/EU/EM deal extensions and identified portfolio gaps • Preparation of detailed business case and management approvals • Negotiating technical and commercial deal terms • Executing CDAs, terms sheets and definitive agreements with external partners • Coordinate with internal stakeholders (Regulatory/IP/Quality/PMO/Legal/Supply Chain) and partner/s to ensure smooth execution and delivery of project milestones • Country market research to identify new business opportunities, new approvals and launches and M&A Business development and Licensing, MS Office expertise, Networking, Data analysis and strategic decision making, Learning attitude, result orientation, people management

Job Summary: We are looking for an experienced and strategic Regulatory Affairs leader to head our Regulatory function. The ideal candidate will oversee all regulatory submission activities, ensure timely approvals, maintain compliance with evolving global health authority requirements, and provide expert regulatory guidance for new and existing pharmaceutical products across ROW & regulated markets. Key Responsibilities Regulatory Strategy & Compliance: • Coordinate with agents, partners, and MOHs to define submission strategies. • Prepare internal strategy documents and lead regulatory discussions for new products. Dossier Management & Submissions: • Manage CTD/ACTD/eCTD submissions for new registrations, renewals, and variations. • Ensure dossiers and query responses are complete and compliant. • Coordinate with plants for registration samples and related documentation. Stakeholder Collaboration: • Work with internal teams and external partners to gather and finalize technical documents. Regulatory Operations Oversight: • Compile and submit responses to MOH/partner queries on time. • Track regulatory submissions as per calendar. • Oversee renewals of FDA licenses, WHO GMP, COPPs, etc. Training & Regulatory Intelligence: • Conduct training on updated guidelines. • Share critical regulatory updates with teams. Documentation & Reporting: • Review technical and administrative dossier sections. • Maintain monthly regulatory status reports. • Coordinate site registrations and pre-audit activities. Leadership & Team Development: • Guide the RA team for efficiency and compliance. • Promote process improvements and regulatory best practices. • Handle additional tasks under the RA function. neetij@selectsourceintl.com

Role Overview: Games2win is looking for a talented and experienced Content Producer to lead content for the popular mobile game Decisions. As a Content Producer, you will be responsible for sourcing in-game music, sound effects, character expressions, and overseeing the overall art aesthetics of the game. Key Responsibilities: - Source in-game music for new stories and their scenes and chapters - Source Sound Effects (SFX) to enhance the story narratives and special situations - Source and manage Character expressions for a 2D story format - Monitor and maintain the quality of characters, costumes, game background art, and overall packaging and art aesthetics - Play top competitor games extensively and bring new insights to the team and the game Qualification Required: - A graduate in Fine Arts or Liberal Arts with expert-level proficiency in written and spoken English - Experienced in digital content production and management - Exposure to US, EU, and other global markets - Experience leading and collaborating with creative teams - Proficient in Google Sheets and Google Slides - Strong organizational, time management, and problem-solving skills - Passion for mobile games and digital products - Ability to be creative on demand and add value to the game through love and passion Note: The job is based in Mumbai, with office work on Tuesday, Wednesday, and Thursday. The successful candidate will report to the Product Manager at Games2win. To learn more about Games2win, visit their company profile at https://games2winmedia.com/company-profile/.,

Regulatory Affairs Associate (Formulation) Location: Hyderabad Experience: 2-8 years Education: Lifesciences Graduate Immediate Joiners preferred Skills: US, EU, Canada market experience, Formulation, CMC, ANDA, NDA filing, OSDs, Injectables

Role & responsibilities 1.Prepare monthly regulatory MIS reports and present status updates, key metrics, and strategic insights to senior management. 2. Manage relationships with external regulatory consultants, in-country partners, submission vendors, and the external regulatory team to ensure timely regulatory filings and ongoing compliance. 3. Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap analysis, and submission readiness. 4. Liaise with regulatory authorities including (EU, CIS, LATAM, ROW, Asia) and others. 5.Develop and implement regulatory strategies across international markets (EU, CIS, LATAM, ROW, Asia, Middle East, and Georgia) to ensure timely submissions and approvals for product registrations and lifecycle maintenance. 6. Lead the preparation, review, and submission of CTD/eCTD/ACTD dossiers for multiple dosage forms including solid orals, injectables, topicals, and liquids for pharmaceutical and nutraceutical products, as per country-specific guidelines. 7.Manage lifecycle regulatory activities such as renewals, variations, line extensions, and prompt responses to health authority queries across global jurisdictions. 8.Maintain up-to-date knowledge of global regulatory and provide strategic recommendations based on updated guidelines and country-specific requirements. 9.Ensure regulatory compliance for labeling, artworks, inserts, and packaging as per regional regulations and internal quality standards. 10 .Support and participate in regulatory audits and inspections by ensuring the availability of complete and updated documentation and responses. 11.Lead and train junior regulatory staff, encourage cross-market knowledge transfer, and ensure consistent alignment with global regulatory processes and corporate objectives.

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.