Senior Quality Assurance Associate
A worldwide biotechnology company, operating in over 70 markets worldwide, is looking for a Senior Quality Assurance Associate to join their team based in Switzerland. The company specialises in neurological conditions and puts a great emphasis on teamwork and delivering biological products.
- Managing the QA interface with manufacturing and testing partners for commercial and clinical large molecules (parenteral), bulk drug products/commercial finished good products.
- Ensuring quality of product/process transfers, validations, investigations, tracking and resolution of issues in a timely manner as well as process improvements.
- Evaluation of the general performance of contractors and the identification, negotiation, implementation and follow-up of process and systems improvements.
- Organising and conducting quality management review with contract manufacturing organisations.
- Quality management of the product lifecycle management in relation to contract manufacturing, and support to CMC functions such as for review and approval of regulatory filing sections.
Skills and Requirements:
- A minimum of 6 years of experience in similar position in pharmaceutical or biotechnology industries.
- Relevant experience in either manufacturing, development, quality or regulatory.
- Understanding of cGXPs, quality systems and regulations (FDA and EU, knowledge of Japanese or other geographies' regulations is a plus).
- Knowledge of clinical regulations, serialisation operations and experience in a manufacturing facility are highly recommendable.
- 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 in computer skills, such as MS Office.
- Excellent verbal and written communication skills in English and Mandarin.
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 Caleb Mensah at 0203 854 1080 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.