Quality Assurance (QA) ensures that activities and processes within the pharmaceutical supply chain comply with Regulatory requirements and Good Manufacturing Practices. QA duties may include:
- Provide QA input into manufacturing activities for Drug Substances and Drug Products and the approval of manufacturing documentation
- QA release of internally/externally manufactured and packed Drug Substances and Drug products
- Support the pharmaceutical functions with investigations of deviations and other quality and compliance decisions
- Provide pharmaceutical development projects with QA support, such as GMP risk assessment and interpretation of GMP regulations
- Provide appropriate QA input to business improvement projects
- Prepare and deliver regulatory operational plans for allocated projects/products.
- Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents
- Ensure high technical quality of regulatory documentation submitted to health authorities.
- Work flexibly within and across Therapeutic Areas to provide broad regulatory support to ensure the delivery of product team and business objectives.
- Identify potential regulatory risks to the operational plans, and propose options to mitigate risks.
- Contribute to solutions to regulatory issues.
- Ensure delivery of clinical supplies effectively and consistently, balancing cost and risk.
- Understand and translate clinical study protocol requirements into demand for drug product within a clinical study.
- Use simulation tools and supply chain expertise to design optimised, lean supply chains for individual studies and ensure delivery of the end to end supply of materials to meet study needs.
- Collaborate with CRO partners in development of pack design and review the technical part of the outsourcing contract.
- Monitor the budget for individual study supply activities and materials for the project. Manage change in demand and supply, resolve issues, escalating when appropriate.
- Work within GMP Quality Management Systems, including managing deviations, complaints, change controls as appropriate.
- Scientific degree e.g. Engineering, Biotechnology, Molecular Biology, Pharmaceutical
- Comprehensive understanding of the pharmaceutical/drug development process
- Good communicator with experience of interacting effectively across interfaces
- Excellent written and verbal communication skills
- Strong collaboration skills
- Fluent in written and spoken English
- Experience of working within a pharmaceutical GMP environment and/or understanding of Quality Systems and GMP
- Knowledge of Clinical Development processes
- Experience from a pharmaceutical development organization
- Strong negotiating and problem-solving skills, including across functional, geographical and cultural boundaries.
- Capable of making effective decisions
- A high degree of personal credibility
We put high importance in personal qualities. Candidates should possess good social skills and be strong team players. You should be able to work independently, take own initiatives and have a positive, goal oriented and problem solving attitude. It is essential to have good organizational and communication skills.
Business: Dfind Science & Engineering
Deadline for applications: 2018-03-30. Please, make sure to send in your application at your earliest convenience! Selection is on-going and interviews will be held continuously which means the process might be finished before deadline.
For more information contact: Birgitta Nyström +46733434153 firstname.lastname@example.org or Alma Zanqrelle email@example.com
Please keep in mind, e-mail applications will not be considered. Register your profile at Dfind Science & Engineering's webpage and send in your application there.
Dfind Science & Engineering is a recruitment and consulting company within science and engineering. All our consultant managers and recruitment consultants have an education and work experience within the respective field. In combination with extensive knowledge of staff issues and solid experience of recruitment, this means that we understand our clients' need for both flexibility and the right skills.
Dfind Science & Engineering is since 2016 part of Randstad Group. With over 600 000 employees in over 40 countries Randstad is the world’s second largest company within recruiting and staffing.