Specialist (m/f/x) Qualification & Software Validation | Pharmaceuticals | Darmstadt / Mannheim AreaAs a Specialist (m/f/x) for qualification and software validation for this exciting chemical and pharmaceutical company, you will be responsible for the hands-on qualification of production facilities. You'll have the opportunity to contribute your own ideas and experiences. These tasks are waiting for you:Preparing periodic reviews, annual requalification, audit trail reviews for existing pharmaceutical production equipment, such as filling systems for liquids, pure media systemsConduct software validationCompiling URS and conducting risk evaluations in alignment with current GMP requirementsDrafting and revising SOPs related to equipment handling and sanitation proceduresGenerating reports for deviations, managing change control processes, and overseeing CAPA measuresProviding support during external auditsPlaying an active role in enhancing GMP adherenceThis completes your profile:Successfully completed studies in natural sciences, pharmaceutical technology, chemical engineering or similar fieldsExperience in pharmaceutical production and strong knowledge of GMP compliance as well as qualification of systemsExperience in preparing recurring periodic assessments for existing systems and conducting audit trail reviewsTeam-oriented and structured work approach, as well as analytical thinkingVery good German and English language skills both written and spokenWhat the company offers you:Flat hierarchies with room for your own ideasFull-time position with 37.5 hours/week - Friday is a half working dayHybrid working environment possibleCompany pension planMeal allowanceOn-site parkingCorporate benefits About our client:Our client is a specialized company in the development and manufacturing of chemical products and pharmaceuticals. The company is known for its quality, innovation, and customer satisfaction, serving customers in various industries worldwide.

SciPro are continuing to partner with an exciting, fast-growing global organisation who are on a mission to revolutionize healthcare, addressing unmet patient and consumer needs. We are supporting their search for an experienced individual to lead global regulatory strategies for their assigned product. As Director - Global Regulatory Lead, you will be responsible for shaping and executing regulatory strategies and play a key role in ensuring regulatory approvals, optimizing product labeling, and engaging with global regulatory authorities.Key Responsibilities:Develop and implement global regulatory strategies to support product approvals and labeling optimization.Lead the preparation of regulatory submissions, including briefing documents, IND dossiers, and CTAs.Manage communications and meetings with global regulatory agencies.Provide strategic regulatory guidance to cross-functional teams, ensuring compliance with global regulations.Key Requirements:Advanced scientific degree with significant experience in regulatory affairs.Strong communication skills, with the ability to simplify complex regulatory topics.Proven success in negotiating with global health authorities.If you're looking for a role where you can make an impact in a fast-evolving healthcare landscape, we'd love to hear from you.

We are seeking an experienced Senior IT Project Manager (m/f/x) to lead and drive digital transformation initiatives. You will be responsible for overseeing company-wide technology projects, ensuring successful execution, and aligning IT strategies with business objectives. You will have the opportunity to thrive in a dynamic biotech environment, adapting to evolving industry needs and regulatory requirements. These tasks are waiting for you: Lead end-to-end project management for digital transformation initiatives, including planning, execution, monitoring, and deliveryDevelop and maintain detailed project plans, timelines, budgets, and risk management strategiesCollaborate with business leaders, IT teams, and external vendors to define project scope, objectives, and deliverablesWork closely with third-party vendors to ensure project deliverables meet quality and timeline expectationsManage stakeholder communication, providing regular updatesDrive initiatives that contribute to measurable business improvements and successful project outcomesDetails about the workplace:Type of contract: indefinite + full timeVacation: 30 days / yearWorking hours: 40 hours / weekAn opportunity to lead the digital transformationA collaborative and inclusive work environment with a diverse team of expertsThis completes your profile:University degree in information technology, business or a related field, or equivalent qualification5-7 years of extensive experience with IT Project Management and strong understanding of methodologiesIdeally experience of working in a regulated environment (e.g., Pharma, MedTech, etc.)Effective communicator with a strong hands-on mentalityFluent in English; intermediate German skills are preferred Information about our client: Our client is a global clinical-stage biopharmaceutical company that discovers and develops drugs. With their innovation-driven team, the company focuses on vaccines, innovative cancer immunotherapies and protein-based therapies. If you are passionate about leveraging technology to transform businesses and have a track record of delivering complex IT projects, we'd love to hear from you!