QA Manager Commercial - #10513668
CTC Resourcing Solutions AG
Datum: vor 3 Wochen
Stadt: Allschwil,
BL
Vertragsart: Auftragnehmer
QA Manager Commercial – 5873 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 Commercial for 1 year contract with high possibility of extension based in Basel, Switzerland.
Main Responsibilities
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 Commercial 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
- 3-6 years of experience in different positions like pharmaceutical product development/ quality control/analytical development/chemical production or similar operational positions in the pharmaceutical industry
- 3-6 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.
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