QA Sterility
Contracting – Brabant Wallon
Key Responsibilities:
- Facilitate interactions between Global sterility assurance and the CMO under its responsibility by establishing working relationship (Service Level agreement using Key Performance Indicators) with the leaders and main contact people.
- Act as a main point of contact for the CMO in supporting the implementation of the client Sterility Assurance Strategy
- Is the point of contact for supporting the CMO in the establishment of the annual Contamination Control Strategy or Sterility Assurance Road map
- Support CMO in the execution of the annual CCS in the different sterility assurance domains and processes (training, trouble shooting, coaching/mentoring, specific projects) and perform process confirmations on targeted topics
- Partnership with CMO for Key Performance Indicators analysis, trending and escalation, gap assessment versus standards including (Sterility Assurance GQP's and QMS, FDA Guidance, etc.)
- Review with CMO the annual performance in Sterility Assurance and help on the preparation of the next CCS
- Assure availability of Sterility Assurance experts for supporting CMO in a specific domain according to annual CCS priorities.
- Accountable for alignment in way of working and standard works between CMO in Sterility Assurance subjects.
- Is the Sterility Assurance quality generalist and therefore act as SPOC 9Single Point of Contact) in case of issue/question raised by the CMO.
- External advocacy: Lead or influence proactively Sterility assurance external trade associations.
- Developing Capability: Supporting the development of sterility assurance capability across key areas of the business through delivery of training, coaching and mentoring.
Why you?
- Bachelor degree in a Scientific Discipline
- Significant experience in aseptic or bioburden control manufacturing environment (production, QA, validation) with demonstrated successful results, preferably in FDA regulated environment
- In depth knowledge of regulations, guidance, best practices and industry standards related to sterility assurance (for example: GMP, WHO, PDA, ASTM, ISPE, PhRMA, etc.) including review of regulatory files
- Strong technical and quality skills in sterility assurance issue
- Coaching and mentoring capabilities for shopfloor training and education
- Strong verbal and written English language skills & French
Our offer ?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
