4 Eu Gmp Jobs

Alkem Laboratories Limited is an Indian multinational pharmaceutical company based in Mumbai, specializing in the manufacturing and distribution of pharmaceutical generics, formulations, and nutraceuticals across India and over 50 countries globally. Renowned for its top-tier pharmaceutical brands like Clavam, Pan, Pan-D, and Taxim-O, Alkem has consistently secured a position among India's top five pharmaceutical companies. As the IT Business Partner for SCM & Logistics at Alkem, your primary role is to serve as a strategic technology advisor, ensuring that IT solutions are aligned with the company's business objectives for the Supply Chain and Logistics functions. Your responsibilities include optimizing supply chain operations, enhancing logistics processes, and ensuring compliance with pharmaceutical industry regulations. Key responsibilities of the role involve: - Acting as the main IT liaison for Supply Chain, Procurement, and Logistics teams, translating business requirements into strategic IT roadmaps. - Developing and implementing a digital transformation strategy for supply chain operations, focusing on visibility, cost optimization, and automation. - Ensuring IT systems adhere to Indian pharmaceutical regulations, global GxP standards, and data integrity policies to support compliance and operational efficiency. You will be instrumental in: - Leading the enhancement of SAP S/4HANA SCM and IBP solutions to streamline supply chain operations. - Driving warehouse automation through technologies like IoT, RPA, RFID, and AI/ML-based demand forecasting. - Enabling real-time tracking of raw materials, inventory, and finished goods using supply chain analytics and predictive modeling. Your role also includes: - Optimizing inventory management, demand planning, and supplier collaboration through IT-driven insights and analytics. - Supporting serialization, Track & Trace, and regulatory compliance using blockchain or digital ledger technologies. - Improving order fulfillment rates and reducing logistics costs through the implementation of digital tools and automation. Moreover, you will: - Collaborate with SAP partners, IT vendors, and third-party logistics providers to ensure seamless integrations and high system availability. - Work closely with cross-functional teams including manufacturing, procurement, quality, and finance to drive supply chain enhancements. - Establish and maintain robust governance for IT projects, budgets, and vendor SLAs related to supply chain operations. The ideal candidate will possess: - A Bachelor's degree in Computer Science and a Master's degree in Supply Chain Management. - Over 10 years of experience in SCM & Logistics IT leadership roles within the pharmaceutical manufacturing sector. - Proficiency in SAP S/4HANA SCM and any Supply Chain Forecasting tool. - Hands-on experience with automation technologies such as RPA, AI/ML, IoT, and logistics analytics. - Strong knowledge of compliance standards including GMP, GxP, US FDA, EU GMP, CDSCO, and serialization. - Exceptional stakeholder management, project management, and vendor negotiation skills.,

Role & responsibilities Asst Manager / Sr. Executive - Regulatory DRA DEPT- Europe Market @ Pharma Formulation -PUNE City. Person will be responsible for DRA function for Pharma Formulation for Advanced Markets / EU The candidate should be conversant with preparing dossiers for Finished Formulations for EU. Preferred candidate profile Honest, Hard Working. Growth Mindset (Important). Good Communications Skills. Relevant Experience in Pharma Only Candidate with Relevant Experience may apply. We also encourage rightful candidates to write directly to us to "info@vekocare.com" with a proper covering note.

As a Qualified Person within the Quality department at Piramal Critical Care (PCC) in Haarlem, Netherlands, your primary responsibility will be to certify batches of Medicinal Products before release for sale. This includes ensuring compliance with EU-GMP regulations, relevant EU-directives such as 2001/83/EC and 2011/62/EU, Dutch National Legislations, and overseeing that public service obligations are met. Collaborating with key personnel like heads of production, quality control, quality assurance, and supply chain, you will be responsible for supervising the company's activities to ensure continuous compliance with legal requirements. It is essential for the Qualified Person to be regularly present at the facilities where the operations take place. Your role as a Qualified Person involves certifying and confirming that each finished medicinal product batch complies with GMP, Marketing Authorization, and applicable EU and Dutch National laws. You will also be responsible for evaluating deviations, participating in investigations, recording certifications, approving subcontracted activities, and ensuring self-inspections and audits are conducted regularly. Additionally, you will play a crucial role in approving quality agreements, change controls, process validations, and participating in risk assessments, audits, and inspections. It will be your responsibility to keep appropriate records of delegated duties, decide on the final disposition of products, handle customer complaints, and ensure GMP aspects are implemented and maintained in the quality management system. To qualify for this role, you should be eligible to act as a Qualified Person under EC/2001/83 Directive, have experience in certifying sterile and solid unit dose products, and possess some background in quality assurance for narcotic products. Fluency in Dutch and English at a minimum C1-level is required. At Piramal Critical Care (PCC), we are committed to inclusive growth and ethical practices. We offer equal employment opportunities based on merit, ensuring that all applicants and employees receive fair treatment in personnel matters. Join our team dedicated to delivering critical care solutions globally and contributing to sustainable and profitable growth for all stakeholders.,

Role Summary: As Deputy Manager Automation (Pharma Process Validation & Documentation) , you will lead validation strategy, customer interfacing, and cross-functional coordination to ensure seamless project execution and regulatory compliance. This role demands strong technical acumen, leadership capability, and the ability to drive results across departments in a regulated pharmaceutical environment. Key Responsibilities: Lead project documentation and automation activities, ensuring timely execution and alignment with customer requirements. Manage end-to-end coordination for CRMs and KOMs preparing agendas, driving discussions, and capturing actionable outcomes. Define and implement validation strategies and master plans (VMP) in compliance with FDA, EU GMP, WHO guidelines. Oversee validation document preparation ( URS, IPD, PFDs, P&IDs, and FRS ) and ensure timely customer approvals. Supervise and mentor the validation team, ensuring training, performance tracking, and continuous improvement. Maintain compliance with Good Documentation Practices ( GDP ); manage SOP updates and audit readiness. Lead risk assessments ( FMEA ), impact analysis, and closure of deviations/ CAPAs under change control processes. Collaborate with QA, Engineering, R&D, and Project teams to ensure project and validation alignment. Monitor validation progress, analyze results, and present regular status reports to senior management. Represent validation activities during audits and regulatory inspections. Required Skills: Strong understanding of pharmaceutical validation, automation processes , and regulatory frameworks Proven leadership and team management abilities Excellent communication, presentation, and stakeholder engagement skills Strategic thinking with a focus on compliance and on-time delivery Proficiency in MS Office and technical documentation systems