Overview
Senior Quality Assurance Manager GMP/GDP Jobs in Basel, Switzerland at Apsida Life Science
Title: Senior Quality Assurance Manager GMP/GDP
Company: Apsida Life Science
Location: Basel, Switzerland
Job Title: Senior Quality Assurance Manager GMP/GDP
Location: Basel, Switzerland
Duration: 12-month contract (100% full-time)
Company Overview:
Apsida Life Science is currently partnering with a dynamic biopharmaceutical company based in Switzerland, dedicated to discovering, developing, and bringing more effective therapies to patients. This organization is driven by a strong science-based culture and a deep pipeline of innovative compounds targeting unmet medical needs.
Responsibilities:
Provide GMP/GDP quality assurance expertise during the development and commercialization of the company’s products
Ensure all required quality activities are initiated and completed according to the development stage
Ensure that medicinal products are designed, developed, manufactured and controlled according to adequate quality standards
For assigned projects, guide the resolution of complaints, testing issues, deviations, discrepancies and Out of Specifications (OOS), investigations and propose Corrective and Preventive Actions (CAPA) as needed
Establish a quality risk management approach in projects based on Six Sigma concepts and training to ensure that quality is understood and managed by all stakeholders throughout the product life cycle
Manage all required activities to support release of active ingredients, commercial products and/or investigational medicinal products, including approval of master process documentation, batch record review and assessment of change controls
Notify CMC team and management of potential quality, regulatory and lead time issues • Participate, represent and defend quality activities in CMC team meetings
Preparation of GMP/GDP Agreements in collaboration with CMOs and the CMC team
Write, review, and/or approve internal SOPs and other GMP/GDP-related documentation
Support review and optimization of the company’s pharmaceutical quality system by preparing a review of the relevant CMO’s Key Performance Indicators
Release of DS and DP Bulk as defined in the relevant release SOPs
If you are interested in learning more, please reach out to Sweetness Zono at Apsida Life Science:
www.apsida.co.uk
+44 (0) 203 854 4609
Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost-effective, high-quality and trusted recruitment service that puts the candidate journey at the heart of the recruitment process
