Contractor QA Systems & Compliance (m/w/d)
Skills: eQMS,QA Compliance
- Support management of electronic Quality Management System (eQMS), policies and procedures and ensure continuous improvement.
- Establish product & process related documents from acquired products into eQMS, including but not limited to testing methods & specifications, manufacturing instructions, stability studies…
- QA support for regulatory submission/variation and new launches either by reviewing regulatory documents against approved procedures from the eQMS or by establishing procedures when missing.
- Support the preparation of quarterly management review reports and monitor the quality key performance indicators. Maintains and evaluates weekly KPIs.
- Coordinate with involved stakeholders the Quality Events and related actions in eQMS to ensure proper and timely completion of records.
- Support the QA team in the daily operational activities by establishing statements, memos, risk assessments and any GxP relevant documentation.
- Bachelor’s degree in pharmacy, Chemistry or equivalent and min 3-5 years relevant experience preferably in pharmaceutical manufacturing, quality assurance and/or analytical testing.
- Strong background in cGMPs and Quality Management Systems.
- Experience in eQMS (Veeva or similar) is a plus.
- Good oral and written English, German is an advantage.
- Ability to work independently in a matrix environment.
- Collaboration; result-oriented; problem-solving-oriented.