Senior Quality Associate — CSL Behring
NewCHF 68'000 - 103'000
CSL Behring · Bern (BE)
- Location
- Bern
- Contract
- full-time
- Posted
- Yesterday
SalaryCHF 68'000 - 103'000
Role overview
Scopo della Posizione
The Senior Quality Associate is responsible for managing deviations, investigations, CAPAs, product technical complaints and change controls associated with development activities and manufacture of Investigational Medicinal Product within CSL Clinical Development portfolio.
To do this, the GMP Site Quality Associate has the primary purpose of ensuring compliance with GMP/GSP/GxP by providing front‑line quality guidance and support across all phases of Technical Product Development.
- Scopo della Posizione
- The Senior Quality Associate is responsible for managing deviations, investigations, CAPAs, product technical complaints and change controls associated with development activities and manufacture of Investigational Medicinal Product within CSL Clinical Development portfolio.
- e Responsabilità Principali
- Participate in IPT Project and associate delivery team meetings, providing quality/compliance leadership, guidance and advice
- Qualifiche ed Esperienza Istruzione
- A degree in a relevant biological science, with at least 3 years’ experience in at least one of the following areas: Manufacturing under GMP Regulatory Affairs Quality Assurance Relevant Process Development
Main responsibilities
- e Responsabilità Principali
- Participate in IPT Project and associate delivery team meetings, providing quality/compliance leadership, guidance and advice
- Manage deviations and OOS investigations and facilitate/attend Deviation Review Board meetings as required
- Manage and facilitate the deviation meeting process, manage deviations to closure, including significant and complex deviations, to ensure that information recorded is comprehensive and remedial actions are appropriate and executed in a timely manner
- Facilitate change panel meetings, manage change controls to completion, including significant and complex changes, to ensure changes are appropriate and comply with regulatory requirements
- Liaison with Technical departments for quality assurance and compliance related issues
- Manage Product Technical Complaints and associated investigations
- Review and approve Technical Document Change Requests
- Conduct self‑inspections, provide reports in a timely manner, assess responses and provide quality advice to maintain regulatory compliance and continuous improvement
- Provide training in QMS principles as required
Key requirements
- Qualifiche ed Esperienza Istruzione
- A degree in a relevant biological science, with at least 3 years’ experience in at least one of the following areas: Manufacturing under GMP Regulatory Affairs Quality Assurance Relevant Process Development
- Competenze, Conoscenze e Attributi Essenziali
- In‑depth understanding of GMP requirements in the pharmaceutical industry and previous Production, Quality or R&D experience within the pharmaceutical industry
- Sound knowledge of processes for Clinical Trial GMP manufacture
- Understanding of the product development process and environment is desirable
- Good interpersonal, negotiation and influencing skills
- Ability to relate to and communicate with people of different technical skill backgrounds and at different levels from management to operations within CSL Good analytical and problem‑solving skills
- Ability to work well independently and to self‑motivate
- Well‑developed organisational and time management skills PC skills (Microsoft Office)
- Strong oral and written communication skills Team orientated Strong customer focus
Company and context
- CSL Behring
- CSL Behring is a global biotherapeutics leader driven by our promise to save lives.
- Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.
- We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
Additional details
- Mansioni e Responsabilità Principali Requisiti: Qualifiche ed Esperienza
- A degree in a relevant biological science, with at least 3 years’ experience in at least one of the following areas: Manufacturing under GMP Regulatory Affairs Relevant Process Development
- Ability to relate to and communicate with people of different technical skill backgrounds and at different levels from management to operations within CSL Good analytical and problem‑solving skills
- Well‑developed organisational and time management skills PC skills (Microsoft Office)
- Strong oral and written communication skills Strong customer focus Chi Siamo: CSL Behring
Notes and original content
- Mansioni e Responsabilità Principali
- Requisiti: Qualifiche ed Esperienza
- Istruzione
- A degree in a relevant biological science, with at least 3 years’ experience in at least one of the following areas:
- Manufacturing under GMP
- Regulatory Affairs
- Quality Assurance
- Relevant Process Development
- Ability to relate to and communicate with people of different technical skill backgrounds and at different levels from management to operations within CSL
- Good analytical and problem‑solving skills
