6 Pharma Compliance Jobs

The Senior Delivery Assurance Associate at ZS will play a crucial role within the Delivery Assurance Group, working alongside experts to implement delivery assurance practices that drive innovation and ensure consistent adoption of technology delivery best practices across the organization. In this position, you will collaborate with various stakeholders, define processes, oversee process implementation, analyze compliance, monitor CMMI maturity and compliance, and contribute to the development and maintenance of DAG and risk scores. Additionally, you will be involved in managing DAG assets and supporting various delivery assurance initiatives and special projects. Your responsibilities will include conducting project audits/reviews based on CMMI process areas, identifying delivery risks and compliance issues, participating in release readiness reviews, planning QRM cadence, conducting trainings on QMS process assets, maintaining project process maturity, guiding project teams on best practices and project management tools, ensuring adherence to Software Quality Management frameworks, enhancing delivery and operations maturity, coaching project team members on Agile methodologies, and developing enterprise-level Quality Management Systems. To be successful in this role, you should hold a Bachelor's degree in IT or a relevant field, possess a minimum of 5 years of experience in Delivery Assurance and Quality Management, have knowledge and experience in Software Quality Management and Standards, demonstrate proficiency in MS Office and Project Management tools, and exhibit strong communication skills. You should also be adaptable to evolving industry standards, have the ability to manage multiple tasks and meet deadlines, and be creative and analytical in problem-solving environments. ZS offers a comprehensive total rewards package, including health and well-being benefits, financial planning support, annual leave, personal growth opportunities, and professional development programs. Our inclusive culture, career progression options, and collaborative environment empower individuals to thrive both personally and professionally. We believe in a flexible and connected work environment at ZS, which allows for a combination of remote work and on-site presence. Travel may be required based on project and client needs, providing opportunities for professional growth and diverse experiences. ZS is an equal opportunity employer committed to diversity and inclusion. We value candidates from all backgrounds and encourage individuals with varied experiences to apply, even if they do not meet all requirements listed. To apply, candidates must have or be able to obtain work authorization for their intended country of employment. An online application, along with transcripts, is necessary for consideration. For more information, visit www.zs.com.,

As the EHS leader at the Turbhe peptides manufacturing site, your primary responsibility is to ensure full compliance with internal and external regulatory requirements, drive the implementation of a robust EHMS (Environment, Health & Safety Management System), and foster a culture of safety, sustainability, and operational excellence in line with Piramal Pharma's EHS vision. You will be working closely with all departments and the site leadership team internally, while also engaging with external stakeholders such as Regulatory Authorities, Auditors & Certification Bodies, Fire & Disaster Management, and Clients. Reporting to the Head Site Operations at Turbhe, you should possess a minimum of 10 years of experience in the relevant industry to effectively carry out the following roles and responsibilities: 1. EHS Compliance & Statutory Obligations: - Ensure 100% compliance with central and state EHS regulations including Factories Act, EPA, Water/Air Acts, Hazardous Waste Rules, and others. - Maintain all EHS-related documentation, licenses, and statutory records as per audit and legal requirements. 2. EHMS Implementation & Monitoring: - Establish and sustain an effective EHMS aligned with ISO 14001 and ISO 45001 standards. - Conduct Management Reviews, support Corporate EHS audits, and ensure global compliance assessments. 3. Safety Leadership & Risk Management: - Perform risk assessments, safety inspections, and job safety analysis throughout the facility. - Investigate incidents and near misses using root cause analysis tools, driving CAPA implementation. - Ensure strict adherence to Permit to Work (PTW), PPE compliance, and Lockout-Tagout (LOTO) systems. 4. Occupational Health & Emergency Preparedness: - Conduct mock drills, emergency response training, and first aid programs based on the site risk profile. - Supervise industrial hygiene programs, noise monitoring, and employee health surveillance, in coordination with OHC. - Lead Emergency Response Team (ERT) and Safety Committee activities according to statutory norms. 5. Environmental Management & Sustainability: - Lead initiatives for water, air, and waste management in compliance with MPCB norms. - Monitor and report ETP/STP performance and stack emissions, supporting Piramal's corporate ESG goals. 6. People Development & Safety Culture: - Organize EHS onboarding, behavioral safety training, toolbox talks, and refresher programs for employees and contractors. - Drive site-wide EHS campaigns to cultivate a proactive safety culture and act as a change agent for continuous improvement through visual management, Kaizens, and employee engagement. Key competencies for this role include being a quick learner with excellent communication skills, expertise in EHMS design, implementation, and auditing, a deep understanding of EHS statutory requirements and pharma compliance, and strong team leadership and cross-functional coordination abilities.,

As a Compliance Head at a Global Pharmaceutical company based in Pune, you will be responsible for ensuring adherence to the UCPMP regulations and maintaining a robust Pharma Compliance framework. You will be the primary point of contact for all Compliance-related queries, issues, and support for the local management and employees within the Legal Entity. Your role will involve implementing and enhancing the Company's Compliance Management System (CMS) while upholding the Group's minimum standards. Your key duties will include fostering a culture of integrity and promoting a speak-up culture through training initiatives and communication campaigns. You will oversee policy management, ensure the effective implementation of Global Policies and Standard Operating Procedures (gSOP), and provide support for case management within the framework of gSOP Case Management. To excel in this role, you should possess a deep understanding of corruption, fraud, antitrust, data protection, anti-money laundering, and trade compliance. Your expertise should extend to knowledge of local legislations and jurisdictions within the Legal Entity/ELT Area. With 2-5 years of operational experience in compliance, legal, or administrative functions, ideally in a similar industry or consultancy setting, you should have a convincing presence and be capable of engaging with local management effectively. As a trustworthy and integrity-driven professional, you must demonstrate conscientiousness, accuracy, confidentiality, and discretion in your work. Your role will require you to collaborate with individuals across all hierarchies and diverse cultural backgrounds. Fluency in English and Hindi is essential, and proficiency in regional languages will be advantageous for this role.,

About Us: 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. Purpose of the Job: The Local Compliance Officer is responsible for the effective implementation and continuous improvement of Fresenius Kabi's Compliance Management System ("CMS") within his/her area of responsibility. He/she aligns local aspects of the Corporate Compliance Strategy with the ELT Area Compliance Officer and monitors its effective local implementation. He is responsible for conducting the Compliance risk analysis for the Legal Entity, for trainings and daily advice of employees and local management as well as for investigating (respectively supporting the investigation of) local Compliance violations if assigned by the Global Investigation Department. Responsibilities: Act as main contact for all Compliance-relevant questions, concerns and issues and provide respective support and advice the local management and employees in the Legal Entity Ensure the effective implementation and continuous improvement of Fresenius Kabi's CMS in the area of responsibility while adhering to the Group's relevant minimum standards Foster and encourage a culture of integrity and speak-up culture through training and communication campaigns, considering also the results of surveys, compliance case reporting and Internal Audits Be responsible for policy management and ensure effective implementation of relevant Global Policies and Standard Operating Procedures ("gSOP") Serve as contact point within the framework of gSOP Case Management (whistleblowing and investigations) Support internal audits and/or external certifications of the Fresenius Kabi CMS to verify adequacy against international and local standards Support especially the local management in providing adequate tone from the top as well as establishing and fostering Compliance and business integrity as fundamental company values Support local management in performing Compliance risk analyses Develop adequate local Compliance communication material Manage (respectively support) internal Compliance investigations as well as the implementation of disciplinary sanctions Assess Compliance-relevant issues with regards to third party checks, due diligences and approvals Support due diligence process along with locally driven Mergers & Acquisitions transactions Continuous Monitoring and Controlling: Develop and implement meaningful KPis and tools to measure the effectiveness of the Fresenius Kabi CMS and assess the maturity of the local integrity and speak-up culture (Randomly) check the effectiveness of the CMS as well as the completeness and the up-to-datedness of necessary documentation on local level Monitor the legal environment for relevant changes in legislation and identify necessary adjustments within the local/ELT area Compliance strategy Training and Guidance: Identify local training needs, including particular local legal requirements Enhance and complement centrally provided training material with local/ELT area specifics, e.g. with regards to the local legislation and jurisdiction, third parties, risks in important focus markets, etc. Define relevant target group employees in the Legal Entity for Compliance trainings and develop a respective training concept Align with Human Resources function regarding roll-out of training curriculum and tracking of participation (e.g., via a Learning Management System) Advise all employees and managers in the Legal Entity on Compliance relevant questions Compliance Management System Reporting ("CMSR"): Compile reports and statistics with regards to the effectiveness of the Fresenius Kabi CMS in the Legal Entity based on pre-defined key performance indicators with regards to general topics (Code of Conduct, Organization and Case Management) as well as on specified risk areas (Anti-Corruption, Fraud, Anti-Money-Laundering, Antitrust; where specifically assigned Data Protection and Trade Compliance), Internal Controls Report on results of regular Compliance Risk Assessments Preferred candidate profile : Good understanding in the areas of corruption, fraud, antitrust, data protection, anti money laundering and trade compliance as well as knowledge of relevant local legislations and jurisdictions in the respective Legal Entity/ELT Area and 2-5 years of operational experience in a compliance, legal or administrative function in a comparable industry environment or consultancy Convincing appearance and ability to interact with local management Assertive person of trust with high level of integrity, conscientiousness and accuracy, confidentiality, and discretion; strong sense of service and initiative Experience in working with people of all hierarchies and different cultural backgrounds Fluent in English and Hindi, additional understanding of regional languages will be an advantage. If you think you fit the role - drop your resume on : https://fresenius-kabi.sensehq.com/careers/jobs/54594?utm_source=NAUKRI&utm_medium=JOB_PORTAL or apply on the job post. Thanks Team HR Fresenius Kabi

Software Development Lead Roles & Responsibilities Lead complex software projects from conception to deployment. Manage software delivery scope, risk, and timeline. Rapid prototyping expertise, translating concepts into working code quickly. Provide technical guidance and mentorship to junior developers. Contribute to both front-end and back-end development using cloud technology. Develop innovative solutions using Generative AI technologies. Conduct code reviews to ensure quality and adherence to best practices. Create and maintain software documentation on architecture, design, deployment, disaster recovery, and operations. Stay updated with industry trends and advancements. Collaborate with product teams, business teams, and stakeholders. Design, develop, implement, and maintain applications with configurations, custom reports, interfaces, and enhancements. Analyze and translate technical requirements into software architecture specifications. Implement unit tests, integration tests, and other testing strategies for software quality assurance. Integrate applications with external systems for seamless data flow and functionality. Provide ongoing support and maintenance, ensuring smooth system operations. Improve reliability, scalability, and performance of applications. Develop and maintain monitoring tools and dashboards for system health tracking. Respond to incidents, conducting root cause analysis and implementing preventive measures. Implement security measures to protect against unauthorized access and cybersecurity threats. Basic Qualifications Doctorate degree OR Master's degree with 4-6 years of Computer Science, IT, or related field experience OR Bachelor's degree with 6-8 years of Computer Science, IT, or related field experience OR Diploma with 10-12 years of Computer Science, IT, or related field experience Must-Have Skills Strong business acumen with deep understanding of pharma regulations and compliance. Expert knowledge of submission publishing systems (Lorenz's docuBridge, Disclose from Citeline). Familiarity with ClinicalTrials.gov and EudraCT. Experience with Regulatory Veeva Vault. Proven success in managing technology initiatives, driving innovation and talent development. Exceptional collaboration and communication skills, with ability to manage multiple priorities in a fast-paced environment. Expertise in technology standard practices (Scaled Agile (SAFe), ITIL). Strong knowledge of information systems and network technologies. Good-to-Have Skills Extensive experience with eCTD specifications and highly regulated (GxP) systems. Leadership experience in pharmaceutical or technology organizations. Strong understanding of software development lifecycle for GxP Systems. Experience in Scaled Agile Framework (SAFe) adoption. Analytical and critical-thinking skills for effective decision-making. Ability to manage projects in dynamic, fast-paced environments. Established business partnerships and IS governance expertise. Broad knowledge of key IS domains and layers. Professional Certifications (Preferred) ITIL Certification (preferred). Scaled Agile Framework (SAFe) for Teams (preferred). Veeva Vault platform Certification (preferred). Soft Skills Excellent analytical and problem-solving abilities. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented focus on achieving collective goals. Strong presentation and public speaking skills.

About the Position As a Senior Salesforce Developer, you'll play a vital, customer-facing role that combines technical expertise and business insight to deliver robust solutions on the Salesforce Health Cloud platform. Youll collaborate closely with cross-functional teams (IT, Patient Services, Compliance, Data Governance, Cybersecurity, Marketing) to ensure Salesforce solutions are aligned with our business and patient service goals. Role & responsibilities : Design, develop, and implement customized solutions in Salesforce Health Cloud (custom objects, Lightning components, Apex triggers, etc.) Gather and analyze requirements from stakeholders to deliver scalable solutions .Integrate Salesforce with external systems using APIs and web services Support and maintain call center telephony and technology Communicate complex technical concepts in a business-friendly manner Manage project timelines, enhancements, and platform optimization Monitor system performance and ensure rapid issue resolution Stay current with Health Cloud updates and Salesforce best practices Ensure compliance with PHI and pharmaceutical industry standards Preferred candidate profile : Salesforce Certified Platform Developer II (Required) Strong understanding of Salesforce architecture and APIs Expertise in Apex, Visualforce, LWC, and web technologies (HTML, CSS) 5+ years of Salesforce development experience (Health Cloud preferred) Experience with customer-facing solutions and call center technologies Strong domain knowledge in pharmaceutical/patient services Excellent verbal and written communication skills Agile methodology experience