Head of Documentation Support (m/f) – Stability Testing

Job description

Would you like to utilize your expert knowledge in biopharmaceutical stability testing, documentation and data evaluation as well as your strong knowledge in regulatory requirements?
If so, seize this opportunity and join us as Head of Documentation Support within our department Biophamaceutical Quality!

Job Profile

· You are the technical and disciplinary leader of the team ‘Documentation Support Stability'
· You are accountable for the process of compiling product and batch related stability data of the departments Quality Control and Analytical Development
· In regards to stability reports, PQRs, dossier, etc. you ensure e.g. the timely compilation, correctness, completeness and development of process
· You act as interface to compliance and other documentation functions within global Biopharmaceuticals
· Furthermore you manage improvement projects regarding stability testing and documentation around interfaces to other respective functions in global Biopharmaceuticals, corporate quality and production
· You act as specialist for stability testing, stability data evaluation and trending
· The support of customer audits and inspections of GxP and non-GxP agencies (e.g. FDA, EMA, TÜV, BfArM etc.), BI compliance functions and consultants belong to your further tasks
· You investigate and resolve observations noted during inspections/audits and collaborate to an adequate responding to audits/inspections
· Additionally you manage and establish KPIs, reporting and scorecards for the field of responsibility

Requirements

· You hold a diploma, master's or doctoral degree in Pharmaceutics, Chemistry, Biotechnology, other related fields or comparable education with relevant longtime experience
· You have at least 3 years pharmaceutical experience in operational functions within the pharmaceutical industry and profound knowledge of quality assurance, analytical testing and/or manufacturing
· Knowledge of biotechnological manufacturing, analytical testing and respective guidelines are desired
· Your in depth knowledge of the pertinent international regulations regarding documentation, stability testing, evaluation and trending of stability data (EMA, FDA, WHO, ICH, etc.) are essential for this position
· Furthermore you have strong experience in managing stability studies
· Experience with electronic documentation and LIMS systems will be a plus
· Your excellent communication and negotiation skills in German and English enable you to communicate efficiently and effectively with your colleagues and partners
· In addition you are characterized by your strong leadership skills and the ability to manage complex, cross-functional projects and programs