Position Summary: We are seeking an experienced and highly motivated GMP Auditor to join our Global Quality team. This role is primarily responsible for conducting GMP audits of Specialty and Biosimilar products, as well as third-party suppliers across all the global regions. The ideal candidate will have deep regulatory knowledge, strong risk assessment capabilities, and experience with inspection readiness and cross-functional collaboration. Key Responsibilities: Audit Execution & Compliance Planning, Preparing, Conducting and Reporting of GMP/GDP and Quality system audits at Third party contractors for Specialty/ Biosimilar products (Finished dosage manufacturers, API manufacturers, key intermediate manufacturers, Excipients Manufacturers, Packaging Material Manufacturers, Contract Manufacturers, Contract testing labs, Contract Research Organizations) to monitor that all aspects of the operational business comply with applicable GMP / GDP legal and regulatory requirements (e.g. National and EU requirements), and the STADA Group Quality Standard in close cooperation with the Global Quality Supplier Management & Auditing Team located at STADA Arzneimittel AG Headquarter in Germany and STADA Hemofarm SRL in Romania. Ensure compliance with EU GMP, ICH Q7, 21 CFR 210/211, and internal STADA Group standards. Prepare and distribute audit reports, review CAPAs, and ensure timely closure and KPI tracking. Conduct due diligence and qualification audits for Biosimilars/ Specialty and new CMOs. Perform Pharmacovigilance and GCP audits as required. Risk Management & Inspection Readiness Ensure global standards and processes developed and in place to support specialties/biologics Support global risk management initiatives and inspection readiness for FDA, EU, and ROW markets. Assess site issues, deviations, and contribute to resolution planning. Develop and maintain CMO risk ratings for the Global Specialties portfolio. Communicate high-risk CMOs and mitigation strategies to leadership. Inspection readiness: Participate in internal audits, CAPA evaluations, and support health authority inspections. Collaboration & Reporting Align and collaborate with other regional and global auditing teams. Support global quality improvement initiatives and cross-functional projects. Prepare monthly reports, risk assessments, and maintain KPI metrics. Contribute to the development of global standards and auditing best practices. Travel Requirements Willingness to travel across all regions Qualifications and Experience: Education: Bachelors degree in Pharmacy, Chemistry, Biotechnology, or a related field MBA from a recognized institution is a plus Professional Experience: 8–10 years of experience in pharmaceutical, biopharmaceutical, or chemical industry Hands-on experience in QA/QC, Production, or R&D functions of Specialty and Biosimilar products Proven track record in auditing third-party manufacturers in line with EU GMP and FDA regulations Strong knowledge of global regulatory requirements (EU, FDA, ICH, ROW) Skills: Excellent audit and risk assessment capabilities Strong interpersonal and cross-cultural communication skills High proficiency in Microsoft Office and auditing tools Fluency in English (spoken and written) Strong organizational and multitasking abilities Flexible and adaptable to changing priorities and deadlines
Employment Type : On Contract _ till December 2026 Role & responsibilities: Lead Global GxP relevant IT Projects. Perform Global Quality Approval and Release of GxP relevant IT System Validations Manage, create, implement and maintain of harmonized STADA Global GxP Computer Validation System (CSV) Governance. STADA Global Quality Expert and CSV Champion to provide support to local, cluster and global teams in IT Validations in compliance with Health Authority requirements. Lead STADA Global GxP relevant IT Projects Lead Quality and other Business Teams in IT System Projects to ensure compliance with Health Authority requirements, such as, GxP and Data Integrity Prepare in collaboration with STADA Global IT highest level of Validation Governance documents, such as Validation Plans, in compliance with CSV regulations. Lead success closure activities of all required GxP relevant documents that are required for releasing the Global IT system for use/production. Present Projects to STADA Global Leadership members, including TechOps and Global IT Senior Vice Presidents and Global Quality Leadership Team. Global Quality Approvals and Releases Approve or ensure compliant approval process of Global GxP Validation key documents, including Validation Plan, URS, Risk Assessments, Testing Plans, Change Controls that are governing the GxP relevant IT System Validations. Approve and Release for use/production Global GxP relevant IT Systems, including but not limited to eQMS, EDMS, RIMS, LIMS and SAP. STADA Global Governance of GxP CSV Develop strategies to harmonize STADA Global approach on IT validation for GxP systems to ensure lean, efficient and compliant processes. STADA Quality Leader for Global CSV creation, implementation and continuous improvements. Identify any gaps of STADA Global CSV against Pharmaceutical Health Authority regulations, including but not limited to EU GMP Annex 11 and Data Integrity. Lead required enhancement initiatives to ensure compliance. STADA Global Quality CSV Expert and Champion Global Quality CSV expert during Health Authority Inspection, including all STADA operational sites and commercial affiliates. Quality Expert during customer audits at STADA. Quality Expert in STADAs audits at IT system service providers. Global Quality Expert for STADA GxP IT Validation Project Managers, System Owners, Business Owners, Process Owners and Key Users. Global Quality Expert to STADA internal and external clients on any GxP CSV related enhancement initiative and resolution of identified issues, including Data Integrity. Provide training to internal STADA customers related to GxP relevant electronic systems. Preferred candidate profile: Minimum 5+ years of experience in Pharmaceutical Quality IT role. Strong knowledge on GxP and Pharmaceutical Health Authority requirements on Data Integrity, electronic and automated systems, including EU GMP Annex 11. Strong experience in GAMP principals or similar. Experience in latest IT developments, including Cloud solutions Proven experience in leadership and in execution of GxP relevant IT systems. Proven experience in providing training on electronic systems and relevant Quality regulations. Experience in Global electronic and automated systems, preferable with SAP, EDMS, LIMS. Experience with matrix organizations and either in European or global position Fluent English Ability to work directly with Global Quality Leadership members including Global Senior Vice President, other Global and Cluster Heads, Global Project leads, Subject Matter Experts and project team members. Proactive, self-driven, highly motivated, takes responsibility seriously, cooperative, able to work under pressure Good communicator, excellent soft skills Ability to structure complex facts in an understandable fashion Willingness and capability to take decisions Technical understanding of electronic and automated systems Qualification : Graduation / Post Graduation in Pharmacy, Natural sciences, Engineering or equivalent, or long-term experience in the pharmaceutical industry
Role & responsibilities: To arrange and undertake cost effective and time-efficient transportation of consignments to wherever necessary To consolidate and centralize transportation across affiliates for supplies from India. Exchange of mode of transport with STADA planning and product managers, STADA affiliates and communication of the same to the shipper (for products with all incoterms). Escalation point trouble shooting and resolution of issues with Shipping Agents and Shippers during the shipment process. Major Accountabilities: Accountable for export shipment from India to primarily to EU region (May expend to other Regions) Maintenance of Master data & related SOP Reviewing Monthly dispatch plan received from CMO Ensuring timely availability of MOT from ESO Purchaser Ensuring availability of pre-requisite permissions for export of products Follow up for shipping documents and pallets details of ready products Co-ordinating with CMOs production site for timely movement of products Planning consolidated shipment wherever LCL shipment available with CMO Tracking of shipment pre-alerts and Product deliveries at destination Ensuring transport should be arranged as per Products approved storage conditions For CIF shipment, actively negotiate with contracted shipping agent to obtain best freight rates To obtain necessary freight approvals from Director, Global logistics & Affiliates for freight charges To coordinate with overseas warehouse to obtain favorable delivery slots to avoid storage changes at port Keeping track of product samples shipped to Timisoara lab Facilitate Temperature Data loggers & Thermal blankets arrangement, as needed Support ad-hoc Logistics support request made by Affiliates Facilitates as Escalation points to troubleshoot & resolution with shipping Agents, Shipper & Affiliates during End to End shipment process Tracking complaints pertaining product damage/ temperature deviation during shipment Preferred candidate profile : 5 to 8 years of work experience in Export shipment handling Preferable from pharmaceutical or chemical industry Working knowledge of Microsoft office (Excel, Outlook), SAP R3 Soft Skills: Clear, concise and well-structured communication skills Moderate Analytical Skills and interpretation Strong stakeholder engagement and interpersonal skills A passionate, ambitious mindset. Professional: Knowledge about shipping industry Should aware of INCO terms, End to End Shipment handling Able to think, act and initiate in operational, tactical and strategic terms. Resolution of challenges and planning