2 Gmp Experience Jobs

Be the First to Apply Job Description Business: PCC Department: Supply Chain (Vap Ops) Location: Italy Travel: 20% Job Overview The Senior Vaporizer Ops Specialist is responsible for providing support for ordering, placement, tracking and the life cycle management process for Piramals vaporizer fleet in Italy, Germany, France, Spain, Portugal, and UK. Key Stakeholders: Internal Sales, Finance, Logistics, Purchasing, Quality Key Stakeholders: External Vendors, Customers Reporting Structure Manager, Vaporizer Operations Experience Bachelors degree in Business, IT or Supply Chain or equivalent combination of education and experience in a role utilizing customer service, business operations, contract administration, or asset management skills Strong Microsoft office experience with experience in advanced formulas (i.e. pivots, formulas) required SAP experience highly preferred Strong data analysis skills and experience in reporting desired Asset management experience strongly desired Prior GMP experience and experience working with Class II medical devices beneficial Competencies Positive attitude; exceptional phone and email etiquette Strong logical problem solving competency Experience in providing excellent customer service and handling internal customer requests, complaints, and resolving issues in a timely manner with effective communication Excellent written and verbal communication skills with experience in handling difficult situations and short timelines when needed in a professional and proactive manner Team player and ability to work cross-functionally to support the needs of internal and external stakeholders. Evaluates, acts and communicates. Strong initiative for execution and proactively addresses issues Essential Duties And Responsibilities Vaporizer Account Management & Customer Support Assists and supports Sales in processing Vaporizer requests according to established procedures and guidelines. Acts as the key point of contact (POC) and subject matter expert (SME) for vaporizers in the assigned territory. Order entry of vaporizers to 3PL/Vaporizer agency vendor (where applicable). Coordinates the movement of vaporizers with customers, distributors, vendors, sales and 3PLs, making necessary updates/maintaining information in system of record (SAP and/or other) to ensure accurate tracking of company assets. Coordinates installation of assets, facilitating with customers and 3rd party vendors serving as POC for all questions by customers and installers throughout the process. Work with Sales on forecasting, purchasing, installation and maintenance of vaporizers. Vaporizer Life Cycle Management Reviews vaporizer complaints in CHEX system and coordinates with QA, Sales, Customers and other parties to ensure complaints are addressed and closed in a timely manner. Coordinates shipments of replacement vaporizers to ensure no interruption of service for customers. Issues Return Material Authorizations (RMAs) for vaporizers to be returned and tracks receipt to ensure 100% control and accountability of assets. Reconciliation of RMAs and return of assets. Supports finance in customer invoicing for non-return of vaporizers. Coordinates vaporizer repairs and maintenance process with warehouse and appropriate vendors, including repair process, keeping complete account of the status of vaporizers in system of record. Obtains and stores recertification documents, ensures POs are closed with vendors and delivery dates are accurate in system of record. Monitors installation process: ensures documentation of installations are obtained and reviews vendor invoices for payment. Monitors sales forecasts vs actual sales, inventory levels and production schedules for deviation from plan initiatives. Works with manager to develop forecast and action plan to replenish stock. Performs audits of vaporizer data to ensure complete documentation and control of company assets. Other Vaporizer Operations Where applicable, ensure regular data analysis for verifying data accuracy in SAP, CRM, and other applicable external systems. Creates and maintains department Standard Operation Procedures (SOPs) in accordance with the Piramal Product Lifecycle Management system. Generates daily, weekly and monthly reports as required related to department KPIs. Performs duties to support Vaporizer placement in other international markets when needed. Other duties as assigned Job Info Job Identification 9032 Job Category Supply Chain Posting Date 07/30/2025, 07:55 AM Job Schedule Full time Locations Via XXIV Maggio, 62/a, Verona, 37057, IT Show more Show less

As part of the Batch File Review Team at PCI, your role will involve compiling and reviewing batch documents across various process types such as OSD, Sterile, Biologics, Cell Therapy, and Gene Therapy. You will work closely with internal and external stakeholders, preparing documentation for Quality Person (QP) review, coordinating corrections, and ensuring compliance with regulatory requirements. This position offers a diverse range of responsibilities and serves as an ideal foundation for those considering a future career as a QP. Key Responsibilities: - Compile and review batch documents, ensuring accuracy and completeness prior to QP review. - Collaborate with site personnel to address any required corrections and prepare Certificates of Compliance (COC) for QP approval. - Conduct batch file reviews for products manufactured/packed at PCI or third-party facilities. - Raise and report deviations, corrective actions, and non-conformance issues promptly, ensuring timely resolution. - Request and review Certificates of Analysis/Conformance for API/Drug Substance, Bulk Product, and Packaging records. - Coordinate product supply chain activities, including imports and exports to the European Union. - Participate in customer meetings to discuss and summarize necessary quality documentation. - Develop and update Standard Operating Procedures (SOPs) and work instructions as needed. - Maintain batch documents and retain samples in the archive room, updating the Product Quality Review (PQR) database post-QP release. - Ensure adherence to safe work practices and report any incidents to the Environmental Health and Safety (EHS) Department. - Perform additional tasks as required to support the company's overall objectives. Essential Requirements: - Degree and/or relevant experience in a related field. - Previous experience with Good Manufacturing Practices (GMP) and Sterile manufacturing. - Strong communication skills and ability to problem-solve effectively. - Minimum of 2 years of experience in Quality Assurance roles. - Demonstrated track record of achieving results through leadership and management. - Proven ability to set and achieve clear goals within defined timelines. Join us at PCI and play a vital role in bridging life-changing therapies to patients. Let's shape the future together. Equal Employment Opportunity (EEO) Statement: PCI is committed to fostering an inclusive workplace environment that upholds the values of equity and inclusion. We strive to create a culture of understanding, respect, and equal opportunity for all individuals at every level of the organization. By continuously assessing our practices, policies, and programs, we aim to build a community where everyone feels a sense of belonging and can thrive.,