- Term of employment
Biotechnology / chemistry / ph...
NonStop are looking to speak with External Quality Professionals, interested to work in Zurich , we currently have an opportunity for an on at least a 12 month contract Currently they are gaining traction in the market as the one to watch allowing you to gain huge exposure with a recognised name, giving yourself future opportunities for growth.
This is a long term contract to be based on site in Switzerland with a very reputable name, giving you the chance to grow professionally and allow access to further opportunities both internally and externally moving forward, to progress within your career.
- Responsible for complying with the requirements of the Quality Incident Management process for relevant CMO/ Supplier manufactured products. Prepares and issues notifications and prepares for Quality Alignment Meetings in collaboration with the ESQL and/or Site Quality Head, and other stakeholders.
- Establish quality and compliance expectations for CMOs/ Suppliers and support as needed CTLs; performing strategic systems reviews and coordinate risk/benefit analyses of supplier processes and systems to assure compliance with relevant standards/ cGMP and Quality System expectations.
- As necessary work with specific LOCs to assure compliance with country-specific requirements/regulations for the manufacturing/ packaging of product for represented markets.
- Support and/or lead audits of CMOs/ Suppliers and CTLs, including preparation of audit reports and review of the acceptability of CMO/CTL corrective actions.
- Provide oversight in the assessment of changes or deviations for products, to assure compliance to market/ regulatory commitments, assessment and evaluation of risks, support appropriate disposition of product, and correction or improvement of operations to minimise future risks.
- Maintain awareness of relevant legislation and regulatory guidelines, and assure that QA supplier management programmes, systems and controls, are reviewed and updated as needed to assure compliance. As necessary, confirm requirements and regulations of other markets in support of manufacturing, testing and packaging activities.
Education / Experience
- Minimum of Bachelor's Degree in Pharmacy, Chemistry, Biology or related discipline and minimum of 5 years of QA/QC experience in the pharmaceutical industry and/or QA/QC laboratory environment.
- Experience of cGMPs, ICH and other pertinent regulations.
- Project Management expertise desired.
- Familiar with Common Technical Documents (registration files).
- Fluent English
Call me Daniel Watson at NonStop Recruitment now for a confidential conversation. Contact me on D.Watson@nonstop-recruitment.com or +41 435 080 817, please send your CV in word format OR if this does not sound like the opportunity for you, but you are a clinical research professional within the pharmaceutical, medical device or biotech industry, please feel free to get in touch, to see other opportunities we may have within this field.
NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.