Specialist Qa

Orion Group Life Sciences are looking for a Specialist QA for our Multinational Pharmaceutical/Biotechnology client based in Breda. Initial 12-month contract, with a high possibility of extension. Hybrid role, where you are required to be onsite three days a week. Accountabilities Perform QA support and oversight for validation of equipment, automation and information systems. Perform review and approval of equipment and automation validation documentation, ensuring that Corporate, Site and Regulatory requirements are met. Provide guidance and direction to operations staff in regard to compliance with quality policies, standards and procedures. Provide quality engineering support for testing strategies and quality investigations. Main Responsibilities of the role Process, equipment and IS validation. Agrees on strategy and provides guidance regarding design, characterization and validation in cooperation with PD / M&E / IS, while ensuring GMP quality and compliance. Reviews and approves validation documentation. Maintenance & Engineering support. Reviews and approves changes to equipment (e.g. parameter changes, like for like assessments, …). Reviews and approves changes to M&E procedures (e.g. change over process, preventive and corrective maintenance). Device and combination product. Manages ABR’s device responsibilities and ensures alignment with GMP regulations. Quality Risk Management (QRM). Represents QA in QRM activities (pFMEA, QRAES, Computer system compliance). Ensures alignment of site Quality Risk activities with corporate policy and strategy. Reviews quality risk assessment reports. Change control. Performs final review of technical change controls, confirming assessments of different stakeholders are complete and all tasks are correctly represented in the record. Functions as QA SME and collects input from different QA areas to complete the QA assessment for technical changes. Required Qualifications and skills Master degree in Engineering, Pharmaceutical sciences, Process Technology or equivalent. 5-8 years of professional experience in GMP environment. Relevant experience in Equipment and Automation Validation. Experience with pharmaceutical industry. Experience with Nonconformances, CAPAs and Change Control. Proven experience with GMP, equipment and automation/IS validation, computer compliance (Annex 11, Part 11). Proven experience with risk management tools such as FMEA, etc. Proven experience with statistical tools to support e.g. sampling plans and hypothesis testing. Logical and linear analytical skills to evaluate and interpret complex situations/problems using multiple sources of information. Good understanding of quality engineering tools. Keeps overview but also deep dives when appropriate. Effective communication skills at multiple levels and areas (inside and outside of Quality). Good attention to detail and excellent writing skills. Good decision making skills and ability to apply risk based approach. Team player, constructively working together towards solutions. If you would like to have a confidential conversation regarding this opportunity, please reach out to Tim Browaeys, [email protected] or contact Tim on 0044 7593448607 #opportunity #multinational #pharmaceutical #biotechnology #specialist #quality #QA #equipmentvalidation #automationvalidation#processvalidation # ISvalidation #GMP #QRM #changecontrol People are our business worldwide Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.