C&Q Consultant - Life Science
PQE Group · Bucharest, Romania
Apply & track with Apply EdgeAre you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.We are seeking an experienced Commissioning & Qualification (C&Q) Consultant to support a major pharmaceutical manufacturing project in Bucharest, Romania. This position offering the opportunity to work on a high-profile project with an initial duration of one year, with the possibility of extension for up to three years.The successful candidate will play a key role in the commissioning, qualification, and validation activities for manufacturing facilities, utilities, and equipment, ensuring compliance with GMP and regulatory requirements.You will be responsible for:Execute Commissioning & Qualification activities in accordance with project timelines and quality standards.Develop, review, and execute qualification documentation, including:Commissioning ProtocolsIQ, OQ, and PQ ProtocolsRisk AssessmentsValidation and Summary ReportsSupport equipment and system turnover from engineering to operations.Coordinate with engineering, quality, validation, and manufacturing teams.Ensure compliance with GMP, FDA, EMA, and industry best practices.Manage deviations, change controls, and qualification-related investigations.Participate in project planning, scheduling, and stakeholder meetings.About you:+3 years of experience in Pharmaceutical SectorFluent EnglishFluent RomanianProven experience as a C&Q Consultant / Engineer within the pharmaceutical, biotech, or life sciences industry.Strong expertise in:Oral Solid Dosage (OSD) manufacturing facilities and equipmentClean Utilities (PW, WFI, Clean Steam, Compressed Air, etc.)Process GasesHVAC SystemsExperience developing and executing qualification protocols and reports.Strong understanding of GMP regulations and validation lifecycle methodologies.Ability to work effectively within multidisciplinary project teams.
PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.Apply now and take the first step towards an amazing future with us.