Are you an expert in your field, ready to apply your know-how to exciting projects?
Join the Hamburger TECCON Group, a team of over 450 professionals specializing in IT, engineering, and business. We develop innovative solutions for prestigious clients, aiming to discover and nurture human potential by creating tailored connections between companies and talents. Bring your expertise to our projects and actively shape the future.
Responsibilities
* Assists outsourcing projects in global Third Party QA role from onboarding through entire live cycle with impact on the global TRD outsourcing strategy.
* Assists key initiatives in the global TRD Third Party Management work stream.
* Responsible for the evaluation of the compliance status, approval and oversight of Third Parties used in global TRD (e.g. monitoring of Third Party Assessment due dates).
* Manages establishment and final signature of Quality Agreements with Third Parties in alignment with the TA, audit reports, and applicable Novartis SOPs and standards as well as Health Authority requirements.
* Manages the creation and maintenance of SOPs and related documents and sets standards for global QA Third Party management (e.g. SOPs and QA Agreement templates) as per standards and Health Authority requirements.
* Responsible for the execution of risk assessments and performance tracking of Third Parties to allow continuous monitoring and early detection of negative trends, proposing remediation actions and escalating as required.
Minimum Requirements
* Bachelor/Technician education and 5 years’ pharma experience.
* Good knowledge of cGMP, working knowledge in technical development, production or QA.
* Sound scientific, technical and regulatory knowledge.
* Good organizational and decision-making skills.
* Good and proven ability to analyze and evaluate cGMP compliance.
* English, German is a plus.
What We Offer
* Exciting challenges and responsibility: Take on varied tasks and manage your own projects independently.
* Long-term prospects: Join a dynamic and committed team with a future-focused approach.
* Flexible working hours and home office options: We help you balance work and personal life effectively.
* Opportunities for growth: Benefit from diverse professional development and training possibilities.
* Team events: Participate in exciting team events that strengthen collaboration and add variety to your work life.
Your starting salary will be at least EUR 65,000 gross per year, with the potential for market-competitive overpayment depending on your qualifications and experience.
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