We are launching an international division, opening doors to new projects in countries such as Croatia, Ireland, Switzerland, Belgium, and the United States. We are currently accepting applications from consultants eager to embark on an international experience, with the possibility of joining our project with approximately one month's notice. Projects are set to commence between July and September. You will engage in cutting-edge pharmaceutical factories or upgrade existing facilities to meet the highest standards of quality and service. The duration of these projects ranges from six months to one year, working with leading global pharmaceutical laboratories (Big Pharma) and contributing to significant advancements in the industry.What We Offer:* Continuous support and guidance from our experienced team* Accommodation* Motor and food expenses* Comprehensive fiscal treatment* Daily allowances* Monthly flights* Personalized career development planYour main responsabilities will include:* Generating and executing CQV/validation lifecycle documentation: Risk Assessments, Validation Plans, URSs and CQV/validation protocols and reports (including FATs, SATs, IQs, OQs, PQs, etc.)* Working as a seconded resource in a client-site* To support and/or lead validation projects and activities on site, as directed and as appropriate* To prepare validation plans in line with the strategic goals of the client and to manage timely and compliant delivery of the plan* Experience in commissioning and validation of various new technologies and new equipment* To develop and execute Commissioning & Qualification lifecycle protocols as per the specific project requirements* Leading and supporting SATs* Supporting and representing the technical quality team in meetings, visits, troubleshooting exercises and audits* Ensuring manufacturing equipment is qualified in line with production schedule requirements* Developing and writing validation procedures according to GMP and regulatory requirements* Providing continuous improvement for existing validation procedures* Be able to collect data and analyse via sophisticated computer software* Work within the multifunctional project team, interacting and forming effective relationships with the key function representatives (e.g. Production, QA, Engineering)What are we looking for?* Degree in Science or Engineering* Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry. Experience with ISPE best practice Annex 1 / GAMP-5/ Annex 15 GMP EU/ ASTM E2500/ electronic execution* Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.* Expert in reviewing and writing technical reports* Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions)* Experience of sterile / biotech / single use equipment in the bio-pharmaceutical industry &/or API pharmaceutical environment (medical device industry experience also#J-18808-Ljbffr
