Real Life Sciences is currently looking for a QA Consultant for one of its clients, a renowned pharmaceutical company based in Walloon Brabant.
QA Officer Injectable Manufacturing
NATURE & SCOPE
Together with appropriate management, you will be responsible for the implementation and maintenance of an effective Quality Management System to assure that:
- Local technical operations related to the manufacturing of injectable pharmaceutical products (DP) complies with applicable national and/or international regulations and guidelines (GMP) & relevant Quality Policies.
- Marketed injectable pharmaceutical Products are manufactured and supplied in accordance with Product Quality Standards.
- To pro-actively help operations identify, develop and implement quality and operational excellence improvements in response to business requirements, technical changes and regulatory requirements
Under the responsibility of the Head of QA Injectable Manufacturing and in close relationship with Injectable Manufacturing department, ensure the following relevant QA tasks are timely performed.
- Review/approval of Failure investigation, Deviations, CAPA plans, Change control.
- Review and authorization of relevant SOP
These tasks will be closely related to Injectable Manufacturing main activities:
- (Small) equipment preparation (cleaning and sterilization)
- Solution preparation
- Filling: in vials (aseptic or terminal sterilization processes) or syringes (aseptic processes)
- Visual inspection
- Environmental monitoring (viable and non-viable monitoring)
- Experience : Proven experience in Quality Assurance and Sterile Manufacturing. Experience with GMP is needed.
- Experience in operationnal QA (Capa, Deviations, change control, batch records..)
- Knowledge of trackwise is a strong asset
Specific skills :
- Has demonstrated a fact based decision making process, accountability and delivering attitude
- Knowledge of worldwide regulations pertaining to GMP and Pharma policies and procedures.
- Excellent interpersonal relationship skills.
- Excellent oral and written communication skills.
- Well developed sense of discretion and ethics.
- Excellent team player attitude.
- Fluent in English
- Stress resistant
- Independently identifying, communicate and initiate problem solving process
Internal : Team's products relevant players within the Production, QC, Supply & Development department on site
Are you interested in discussing the role further? Please feel free to contact us for more information