QA Manager (GMP/GDP) – 6166 ADA
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.
Qualifications and Experience:
* 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
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