QA Specialist / Engineer

We are a service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998, with more than 1500 employees, 45+ nationalities and 30 subsidiaries all over the world (Europe, Asia and the Americas). Joining PQE means being a part of a multicultural and challenging company, with many local and international projects, and colleagues from all over the world.

Due to a constant growth, PQE is looking for QA Specialist/ Engineer to join our Israel Team.

The candidate that will succeed in this position will be able to create all the testing and automation frameworks as required for their projects. Thus, the candidate may have to work on multiple projects once, also working to improve the company's best practices.

Responsibilities :

• Documentation: Preparation, review of QMS Documents (e.g. SOPs, validation protocols, reports).
• To ensure Management of Change Control, Deviations, CAPA and Trainings are initiated, documented, reviewed and approved in a timely and comprehensive manner.
• Participation in Validation Activity (e.g. facility, process equipment and clean utilities).
• Participation in Internal Audit Programs within the organization.
• Participation in Qualification of various vendors impacting product or process quality.
• Participation in Quality investigations (e.g. OOS, CAPA, Deviations).

Skills :

• Technical skills- Comprehensive understanding of quality and regulatory requirements in biologics manufacturing and controls.
• Good understanding of Good Manufacturing Practices and Quality Management System, especially related to the Quality Unit.
• Understanding knowledge and experience in aseptic processing.
• Basic understanding of Data Integrity (ALCOA+) for all manual as well as computerized processes
• Planning and organizational skills- able to schedule tasks and resources efficiently
• Judgment and problem-solving- able to define decision criteria and determine the most appropriate course of action.
• Team player- Candidate should be a good team player both inter and intra departmental. He/ she should walk the talk and thus help build a strong team of Quality Professionals.
• Work under pressure- Should have ability to work transparently while working with tight timelines.
• Attention to details and quality orientation- able to accurately check processes and outputs.

Requirements :

• Master's/ Bachelor's Degree in Biochemistry, Microbiology, Biotechnology or Chemistry.
• At least 5 years of experience in a similar role in Biopharmaceutical or Vaccine manufacturing Industry.
• Communication and interpersonal skills- Good written and verbal skills. Ability to communicate clearly in English and be able to put forth views both up and down the hierarchy.
• Experience in working with electronic QMS- Dot. Compliance is an advantage.
• Computer literacy, specifically MS Office is a must.
• Languages: (speaking, writing and reading): Hebrew and English at a high level.
• Location : Jerusalem, ISRAEL.