Quality Assurance Specialist

Quality Assurance Specialist

(Medical Devices)

For our client, Switzerland's leading medical device company, we are looking for a Quality Assurance Specialist. This is initially a 12-month contract in Baselland, Switzerland.

General Information:

• Start date:03.01.2022
• End date: 12 Months
• Workload: 100%
• Work Location: Baselland

DESCRIPTION:

This position will provide QA technical support for External Manufacturers in a region. Assist in the development of corrective action plans and monitor implementation. Assist in the development, writing and implementation of quality procedures. Provide QA support for technology transfer and improvement of existing manufacturing processes. Contribute to the overall development, implementation and execution of quality systems in support of the manufacture of pharmaceutical products. Conduct investigations, perform customary audits, collect data, analyze trends, and prepare reports as required.

KEY RESPONSIBILITIES

• Assess current quality systems and recommend improvements in order to enhance quality and reduce cycle time.
• Monitor trends, identify issues, recommend and implement appropriate actions.
• Provide cGMP compliance support to contract manufacturers by investigating and resolving quality issues.
• Coordinate and provide concurrences on deviations, change controls and CAPAs.
• Participate and Lead audits of External Manufacturers.
• Assists with regulatory inspections and provides follow up on regulatory commitments.
• Develop, implement, and review of SOPs for interactions with External Manufacturers.
• Investigate customer product quality complaints.
• Apply cGMP regulations and other international requirements to all aspects of the position.
• Coordinate change control documentation and approval process.
• Provide Quality oversight and participate on technology transfer teams.
• Interface with other functions (Operations, Planning, Technical Operations, etc) in the support of External Supply

ADDITIONAL RESPONSIBILITIES/DUTIES

• Providing support to manufacturing / logistics organizations regarding aspects of GMP compliance associated with technology transfer and international manufacturing.
• Remaining current with HA and local regulations, guidelines, and quality practices associated with the pharmaceutical

SKILLS and PROFILE

• Strong experience in the manufacturing of Pharmaceuticals products and at least 5 years in QA
• University degree (Minimum BA/BS in a scientific discipline) or a Degree in Engineering or natural sciences
• Familiar with EU GMP
• Ideally familiar with Trackwise
• Demonstrated hands-on lab skill set preferred
• Practical experience in a regulated industry
• Well versed in Microsoft Office tools with the ability to communicate effectively electronically
• Continued development of knowledge and expertise as needed in order to perform job duties
• Fluent in English (spoken and written - all documentation in English). French or German is preferred.

Interested in this opportunity? Kindly send us your CV today through the link in the advert. Should you have any questions please contact Elaine Kanwar on +41 61 282 22 23

Even if this position may not be the perfect fit for you, please reach out to us, as we have hundreds of open positions at Experis IT across Switzerland. Check out all of Experis' job openings at www.experis.ch.