QA Specialist | Medical Device and Combination Products

☞ NonStop Consulting

View: 149

Update day: 17-04-2024

Location: Basel Basel-Stadt BS

Category: Pharmaceutical / Chemical / Biotech

Industry:

Job type: CDI

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Job content

NonStop Consulting AG on behalf of our client - innovative mid-size pharmaceutical company in the centre of Basel - is looking for a Quality Assurance Specialist in the field of Medical Devices and Combination Products.

In this role, you will be a part of the global endocrinology QA team, ensuring GMP compliance with our client’s products across the global supply chain, from API to finished products, including devices.

Your technical expertise will support the R&D team and Regulatory functions in the development, clinical trials, and launch of medical devices and combination products.

Key responsibilities:
Establishment of SOPs and processes related to Medical Devices and combination products according to ISO 13485, 21 CFR 820, and CFR part 4;
Support technical development team in compliance with Quality Requirements;
Manage deviations, OOS, and Changes, related to the device, combination products, and drug products in the frame of the development study;
Responsible for complaints management;
Single quality contact for the company, support technical development team, and 3rd parties;
3rd party oversight, (eg quality agreement negotiation, audit coordination, performance evaluation) related to manufacturing and testing sites involved in the device, combination product, and drug product

Requirements for a candidate:
Strong technical experience in Quality System Regulations, Medical Device Directives, and cGMP
Ensure high product quality, including approval of Design & Development plan, Design Validation Plan, Design History File, Design & Usability Risk Assessment, Risk Management Plan.
Technical education in pharmaceutical manufacturing of medicinal products / University degree in Pharmacy, Chemistry or equivalent (desirable)
Good oral and written English and German skills

Ability to work independently in a matrix environment

What can you expect in case you take this role?

Attractive package
Growth opportunities
Stable, open, friendly, and supportive work environment - the company is famous for very high retention of staff members
Hybrid work model: 2 days/week onsite only
A young team of professionals

Contact me for more details:
phone number: + 41 435 080 817 - internal 3594
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Deadline: 01-06-2024

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