Quality Assurance Specialist

6 giorni fa

Bologna, Italia Cellply A tempo pieno

Cellply is an early-stage cellular assay tool company which is addressing critical needs in cellular therapy within pharmaceutical, biotech, and life science research markets. We are looking for individuals who will thrive in a fast-paced environment and can make meaningful contributions to the production team. The role will manage day-by-day QA activities, which are related to analytical tools for the characterization of cell & gene therapy products used by biopharma and research institutes. In addition, the figure designated for this role seeks continuous improvements related to production processes or products, through technical and analytical support. The primary objective is to solve operational or quality-related problems, taking into account productivity and any opportunities for standardization.

Joining Cellply you become part of a group of highly **dedicated people** who pursues its** goals** driven by an **innovative mindset.**

**Responsibilities**:

- Draft, collect, review and organize products documentation (Quality Packs) according to applicable regulations and standards and to company Quality Management System.
- Monitor the quality of the products at all stages of the manufacturing process from materials procurement to product qualification.
- Support R&D and Validation teams by mapping new User Requirements Specification and identifying and managing the impact of changes on the Quality Packs.
- Support Marketing in defining the regulatory strategy for the product by identifying applicable regulations and standards for pharmaceutical products manufactured by CellPly’s customers, with reference to cell & gene therapy products and preparing documentation to interact with regulatory agencies.
- Collaborate with internal team and external consultants and stakeholders to ensure that all the information is collected effectively and efficiently and interact with external customers to collect regulatory requirements of pharmaceutical products.

**Requirements**:

- MS or higher degree in CTF, pharmacy, engineering
- Previous experience in the role for at least 1 year
- Strong communication and relational skills
- Good knowledge of Office Suite
- Fluent in written and spoken English
- Proactivity, attentions to details and precision

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