About Innovative Medicine
Our expertise in Innovative Medicine is inspired by patients, whose insights fuel our scientific progress. Visionaries like you work in teams that save lives by developing tomorrow's cures.
Join us in developing treatments, finding cures, and pioneering the path from lab to life, supporting patients at every step of the journey.
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We are looking for the best talent for the role of Quality Assurance Associate – Master Data based in Latina.
The position is a 12-month fixed-term contract.
Purpose
The selected candidate will join the Quality Assurance area, which is responsible for ensuring, through verification of compliance with standard operating procedures and appropriate tools, that product quality conforms to specifications and current regulations (GMP).
Responsibilities
•Approve production documentation (Master Batch Record and recipes) and the master data of materials, equipment and resources (Master Data), ensuring timelines and quality of the entire process are respected, monitoring cycle time and coordinating with the global team for Master Data approval.
•Control and ensure management of critical Master Data, in accordance with GMP and quality/compliance requirements defined by company procedures, ensuring their relevant approval.
•Collaborate and participate as the Quality reference for the site in cross-functional project teams (New Product Introduction, Technology Transfer, Technical Launch, Validation Process) to ensure product launch dates on the market.
•Support quality processes, including non-conformance management, monitoring implementation of corrective/preventive actions and Change Control requests related to assigned projects.
•Manage resolution of issues across different plant departments related to product, process, and equipment/facilities/utilities management to ensure product quality, safety and effectiveness.
•Act as QA representative in company projects to oversee quality aspects.
•Act as Subject Matter Expert (SME) for Data Integrity, ensuring implementation of processes for correct and appropriate data management, both in terms of system capabilities definition and management and their review and approval process.
•Ensure approval of GMP documents related to IT systems and equipment. Guarantee exclusive use of qualified/validated systems, with appropriate documentation, and ensure correct management of any deviations.
•Provide effective support to the Production Service, delivering the necessary solutions to overcome critical situations.
Qualifications / Requirements
•Master's degree in Chemistry and Pharmaceutical Technologies, Pharmacy, Chemistry or Biology, Engineering, Computer Science, or equivalent
•12 months of experience in the pharmaceutical sector or similar
•Excellent knowledge of English
•Good knowledge of the Office package
•Knowledge of MES systems, preferably PAS-X, and SAP is a preferential qualification
Preferred Skills
Accountability, Administrative Support, Compliance Management, Detail-Oriented, Document Management, Execution Focus, Goal Attainment, Human-Centered Design, Internal Controls, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Report Writing
Compensation
The anticipated base pay range for this position is €30,400.00 - €49,450.00.
Benefits
In addition to base pay, benefits include: an annual bonus with a set target (% of pay) depending on pay grade/location, where the actual amount is based on employee and company performance in the previous calendar year, or sales commissions. Also includes vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, and programs for financial, physical and mental health. Service anniversary and recognition awards are offered, and, subject to the terms of their respective plans, employees (and in some locations eligible dependents) can participate in several insurance plans.
