Quality Assurance Associate III
A global biotechnology company is advertising a vacancy for a Quality Assurance Associate III, to be based in their Swiss office. The institution is known for their work discovering, developing, and delivering innovative therapies for patients with serious neurological and neurodegenerative diseases across the globe. This position is an excellent opportunity to work with an organisation that has cultivated a strong presence in the biotechnological industry and prides itself on its world-class manufacturing facilities.
- Managing the QA interface with manufacturing and testing partners for commercial biosimilar finished products by ensuring:
- quality of product / process transfers
- issues investigations
- tracking and resolution
- process improvements
- Evaluating the general performance of contractors and the identification, negotiation, implementation, and follow-up of process and systems improvements.
- Evaluating the organization and conduct of quality management reviews with contract manufacturing organizations.
- Overseeing the quality management of the product lifecycle management in relation with contract manufacturing.
- Supporting CMC functions, such as reviewing and approving regulatory filings.
Skills and Requirements:
- Minimum of Bachelor's degree in a scientific topic such as Pharmacy, Chemistry, Biology, Biochemistry etc.; a Master's degree is preferred.
- A minimum of 3 years of experience in similar position in the pharmaceutical or biotechnology industries.
- Relevant experience in either manufacturing, development, quality, or regulatory affairs.
- An understanding of cGXPs, quality systems, and regulations (FDA and EU, knowledge of Japanese or other geographies' regulations is a plus).
- Knowledge of medical device regulations and manufacturing is a plus.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact James Wilson at +44 203 762 2703 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.