QA Associate Operations 80%
QA Associate Operations 80%
Jobdescription
For our client, an international company in Rotkreuz, we are looking for a motivated QA Associate.
As a QA Associate, you will drive and support the maintenance and development of the quality systems of the local quality organization. You will ensure compliance with both local legislation and corporate regulations and the readiness for inspections and audits. In addition, you will drive and support processes related to marketed products (e.g. batch release, complaints handling). At the interface between manufacturing and the market, you are the business partner for various functions.
General Information:
Tasks & Responsibilities:
Must Haves:
For our client, an international company in Rotkreuz, we are looking for a motivated QA Associate.
As a QA Associate, you will drive and support the maintenance and development of the quality systems of the local quality organization. You will ensure compliance with both local legislation and corporate regulations and the readiness for inspections and audits. In addition, you will drive and support processes related to marketed products (e.g. batch release, complaints handling). At the interface between manufacturing and the market, you are the business partner for various functions.
General Information:
- Start date: ASAP
- End date: 31.12.2024
- Extension: possible, to be discussed
- Workplace: Rotkreuz
- Workload: 80%
Tasks & Responsibilities:
- Follows GxP and corporate guidelines in day-to-day work.
- Acts as Subject Matter Expert (SME) in the own area of responsibility.
- Takes over process ownership as assigned. The process owner ensures the proper functioning, monitoring and continuous development of a process within corporate regulations and local legal requirements. He/she responsible for the adequate handling of investigations and ensures appropriate training of relevant roles.
- Responsible for the adequate handling and investigation of deviations including their CAPAs.
- Is responsible for maintaining and updating the quality management system within the own area of responsibility.
- Takes over administrative and supportive tasks, where required.
- Supports readiness for all GxP regulatory inspections & audits, as well as self-inspections according to plan.
- Meets Key Quality Indicators (KQI) in the own area of responsibility. Assesses, reports and proactively monitors Key Quality Indicators in the own area of responsibility, maintains good oversight and ensures gaps are appropriately addressed.
- Drives and executes continuous improvement in his/her area of responsibility.
Must Haves:
- Minimum apprenticeship in Natural Science (e.g. laboratory technician, aide in Pharmacy, bachelor degree in natural sciences) or comparable education/scientific background with experience in GxP area.
- Fluency in German and English (oral and written is mandatory), French as advantage.
- Several (3-5) years of professional experience in pharmaceutical industry, analytics, quality assurance, production, distribution or pharmacy.
- Strong interpersonal, communication, negotiation and problem-solving skills.
- Skills in project management, including simplification mindset, strategic thinking and ability to implement changes.
Marta Bartkowiak
Über die Firma
