Job Posting for Lead Operational Quality Assurance (m/w/d) New Assets at Merz Therapeutics
YOUR CONTRIBUTION
Join our global quality operations team and grow with exciting challenges. With your passion and expertise and together with our international colleagues, you will contribute to achieving our company goals. As an Operational Quality Assurance Lead, your responsibilities will include the following tasks:
Lead and develop operational QA for New Assets
Organize, monitor, and enhance the deviation system, process deviations in Jira and ensure timely resolution
Oversee and improve the CAPA system, manage CAPA processes in Jira and ensure timely completion
Manage and maintain training administration for Therapeutics Operations and handle document management in Smartsolve
Develop product documentation for process, transport, and method validation and transfers for New Assets
Create PQRs for New Assets
Represent the area and activities during inspections by authorities and customers
Act as Subject Matter Expert for deviations, CAPAs, and training management
Serve as the contact person for internal and external stakeholders/customers
YOUR PROFILE
Completed scientific Studies in Pharmacy, Chemistry or a related field of studies, PhD is an advantage
Minimum 3 years of experience in the pharmaceutical industry
Several years of proven leadership experience, ideally within Quality Assurance
Good knowledge of cGMP (EU, FDA), GDP and change control processes
Proficiency in Microsoft Office package and database queries as well as electronic QM and SOP systems
Knowledge of national and international requirements for pharmaceuticals and medical devices
Analytical thinking and the ability to understand complex matters
Teamoriented, proactive organizational talent
Strong communication and problem-solving skills with a confident appearance
Excellent verbal and written communication skills in German and English
Your Benefits
Individual career development in a purposeful job: you improve the quality of life of our patients!
Hybrid work model that allows a good work-life balance
Attractive location with good transport links, modern workplaces and a company restaurant
Global family business with flat hierarchies and an open, respectful corporate culture
Attractive remuneration with extensive social benefits
Variety of employer-subsidized benefits such as WellPass, Deutschland-Ticket, Corporate Benefits and JobBike
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Frankfurt, Hesse
Part Time