QA Manager - External Supplier (m/f/d)
Randstad (Switzerland) Ltd.
Publication date:
28 November 2024Workload:
100%- Place of work:Glattpark-opfikon
job details
For one of our clients, an international pharma company in Zürich, we are looking for a QA Manager. In this position, you will report to the Lead, External Supplier QA.
An ideal candidate has Bio/Pharmaceutical background and experience as QA manager. Is familiar with deviation management and process implementation.
General information:
Tasks and Responsibilities:
Must Haves:
An ideal candidate has Bio/Pharmaceutical background and experience as QA manager. Is familiar with deviation management and process implementation.
General information:
- Start date: ASAP
- End date: 18 months contract
- Extension: possible, to be discussed
- Workplace: Zürich
- Home office: possible up to 3 days per week
- Workload: 100%
- Travel: Twice per month to Germany
Tasks and Responsibilities:
- GMP-compliant batch record review and approval of batch documentation as well as timely batch evaluation for externally manufactured products within the responsibility of Vaccine External Supplier Quality (ESQA).
- Preparation and approval of documents for batch release by the responsible institutes/authorities.
- Management of deviations and changes as well as management and tracking of CAPA measures and other QMS documents for external products within the responsibility of ESQA.
- Daily collaboration and communication with external partners, ensuring the company is professionally represented
- Support in coordinating complaint handling with external partners as well as with global and local functions.
- Support in the preparation of inspections by regulatory authorities, as well as internal inspections and global audits at external partners.
- Coordination of documents required by the regulatory department for registration purposes.
- Coordination of Quality Agreements (QAGs).
- Support in the creation of global quality metrics/KPIs for external partners.
Must Haves:
- You have a degree in Pharmacy, Microbiology, Life Sciences, or an equivalent scientific discipline.
- Several years of professional experience in Quality Assurance; Quality Oversight or Regulatory Compliance, ideally in the pharmaceutical or biotech industry.
- Solid knowledge of GMP regulations.
- Demonstrated written and oral communication skills and ability to work in a cross functional team environment.
- Strong interest and commitment to digital transformation and continuous improvement through data analytics and automation is a plus.
- Able to thrive in a fast paced environment with minimal direction.
- You are characterized by a precise, reliable way of working and enjoy teamwork.
- Fluent English required, fluent German preferred.
