Descripción de la oferta
Are 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 currently seeking a Cleaning Validation Consultant to support the site Validation Master Plan (VMP) and maintain the validated state of cleaning processes for manufacturing and packaging equipment. ❗ ❗ This is a 6-month freelance assignment , primarily remote-based , with an expected 20% on-site presence in Sweden . Upon successful completion of this project, there may be opportunities to support additional projects within our broader portfolio, as we continuously manage multiple validation and compliance initiatives. Responsibilities Support and maintain the site Validation Master Plan (VMP) for cleaning validation. Define and implement cleaning validation strategies in compliance with cGMP and regulatory requirements . Lead cleaning validation activities for new product introductions, process changes, and equipment modifications. Develop validation protocols , define sampling strategies , oversee validation runs, and issue validation reports . Coordinate cross-functionally with Production and QC to ensure timely execution of validation activities. Investigate deviations/non-compliance events , perform impact assessments, and propose corrective actions (CAPA) . Update cleaning procedures and validation documentation as required. Act as Subject Matter Expert (SME) during audits and inspections and drive continuous improvement initiatives . Required Qualifications Master’s degree in a scientific field. Minimum 7 years of experience in cleaning validation, production, or quality within Pharmaceutical, Medical Device, or OTC manufacturing . Strong knowledge of cGMP regulations (EU and FDA) . Experience with cleaning methods (manual, CIP, semi-automated) and residue limit calculations . Familiarity with risk management tools . Proficiency in MS Office . Strong leadership, communication, and organizational skills . Fluency in English . Next Steps Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal. Alternatively, if the outcome is negative, we will contact you to halt the recruitment process. Working at PQE Group As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation . 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. #J-18808-Ljbffr
