Lead Quality Assurance Specialist (f/m/d) Pharmaceutical Diagnostics Austria
Job title: Lead Quality Assurance Specialist (f/m/d) Pharmaceutical Diagnostics Austria
Company: General Electric
Job description: This role will act as Responsible Person as described in the Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01).
The future incumbent will ensure compliance with current regulations and industry practice.
The main focus areas in our local Quality Management System include Complaint Handling, Investigations, CAPA, CMO/Supplier management, Change Control Management, Training, Distribution, etc.
At GE Healthcare, our machines, our software, our solutions, our services, and our people make a genuine difference to medical professionals and patients all over the world. That’s because we never lose sight of what healthcare really needs—the human touch.
Due to the documentation needs in quality this role is office based with the opportunity to work from home on a regular basis!
- You will lead QA for pharmaceutical products distributed within Austria and other regions in the EU as needed
- You will be ensuring that GE Healthcare (GEHC) Quality Management System is implemented and maintained
- You manage customer complaints and do customer visits as required
- You will support continuous improvement activities regarding areas of responsibility
- You will analyze & communicate proposed, new or changing requirements & devise strategies for their implementation, ensuring business goals are met
- You will liaise with other GE functions, industry bodies or regulators as required
- You will Ensure that Service Providers and customers are approved
- Management of qualifications and maintenance of Suppliers, CMO’s, Distributors
- Ensure GxP changes in are fed into Regulatory intelligence program for Global assessment
- Translate new industry trends and requirements into business policies and practices
- Identify, assess and manage regulatory risk proactively and provide senior management with key data to help drive decisions
- Responsible for inspection readiness and hosting site inspections, preparing audit observation responses as necessary
- Own compliance assessment and remediation plans while influencing execution, communications and training for Quality matters
- Act as Responsible Person for Distribution in Austria.
- Provide quality support to neighboring countries as needed.
Your Quality Specific Goals:
In all that you do you will:
- be aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
- complete all planned Quality & Compliance training within the defined deadlines
- identify and report any quality or compliance concerns and take immediate corrective action as required
- ensure on-time reporting of the metrics for quality management reviews
- ensure 100% execution on specific QMR action items related to metric establishment and reporting
- maintain expertise to be able to provide required input to operations and projects
- develop expert knowledge of relevant Electronic Management Systems
- You bring a B.S. Degree in business or technical field, ideally in pharmacy, chemistry or another relevant field
- You bring proven professional experience in quality assurance in medical device, pharmaceutical industry or other regulated industry
- You have sound experience with CAPA systems, including complaint handling
- You have proven experience with handling, storage and distribution of medicinal products
- You bring significant experience with vendor/supplier quality management, including quality agreements and supplier audits and corrective actions
- You bring a sound experience applying regulations (GMP, Good Distribution practices)
- You are proficient with MS Office word processing, spreadsheet, presentation, and database applications
- You are able to identify root cause of problem and creatively problem solve to gain resolution
- You are able to work independently in a fast-paced environment with little supervision.
- You are able to adapt to constant change and influence positive change effectively
- You are team-oriented and responsive to customer needs
- You are quality-focused, attentive to detail and results-oriented
- You are able to form, lead, and manage cross-functional and cross regional teams
- You speak and write German and English fluently
Desired Characteristics that can also be trained on the job are:
- You are familiar with continuous Improvement methodologies, including Six Sigma
- You have excellent project management skills
- You are able to communicate in Dutch in order to interact occasionally with local regulative authorities in Belgium and the Netherlands
We are offering a competitive salary at a minimum of 40.000€ for this role with the possibility to overpay, depending on the final candidate’s experience and qualification.
Are you interested in learning more? Then please apply online. For any question upfront please reach out to our recruiter Carolin Krone on . Please note that for Data Privacy compliance we are not able to accept any e-mail applications!
About GE Healthcare
GE Healthcare is a leading global medical technology and digital solutions innovator with over 100 years of healthcare industry experience and around 50,000 employees globally. We enable clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by our Edison intelligence platform. We operate at the center of an ecosystem working toward precision health – digitizing healthcare, helping drive productivity and improving outcomes for patients, providers, health systems and researchers around the world.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
Diversity and inclusion message
GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE Healthcare – every moment matters
Relocation Assistance Provided: No
Job date: Wed, 07 Jul 2021 05:13:48 GMT
Apply for the job now!
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