Job Description

QA Manager (GMP/GDP) - 6852
Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking for a QA Manager with GMP and/or GDP experience for 1 year contract with high possibility of extension based in Basel, Switzerland.
Main Responsibilities:

• Provide GMP/GDP quality assurance expertise during development and commercialization of client'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, provide guidance on 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.
• Assist in the conduct of GMP/GDP audits at 3rd party sites.
• Preparation of GMP/GDP Agreements in collaboration with CMOs and the CMC team
• Write, review, and/or approve internal SOP's and other GMP/GDP related documentation.
• Support review and optimization of the company's pharmaceutical quality system by preparing review of relevant CMO's Key Performance Indicators
• Pro-actively participate to the optimization of the quality system by proposing new procedures, tools or modification of existing ones.
• Release of DS and DP Bulk as defined in the relevant release SOPs.

• Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required.
• University degree in Pharmacy, Chemistry, or alternative technical/science University degree
• 5-10 years of experience in different positions like pharmaceutical product development/ quality control/analytical development/chemical production or similar operational positions in the pharmaceutical industry
• 5-10 years of experience in quality assurance of drug substance and/or drug product
• Knowledge and understanding of drug substance and/or drug product development, manufacturing process, quality control, packaging, and distribution.
• Good knowledge of (c)GMP/GDP's
• Ability to interpret and implement Quality standards.
• Ability to manage complex projects and prioritize workload according to the project importance.
• Ability to pro-actively initiate and lead quality activities.
• Ability to manage multiple tasks with competing priorities.
• Good interpersonal and influencing skills.
• Fluent verbal and written communication skills in English and at least basic knowledge of an additional European language e.g. German/Italian/French