Quality Control Supervisror At Johnson & Johnson Egypt
Duties & Responsibilities
- Coordinating and supervising the day-to-day inspections and analysis of incoming materials, packaging components and finished products to ensure adherence to specifications and company quality & regulatory standards
- Review/approve QC laboratory data for validity and accuracy according to cGMP/cGLP standards
- Review/approve documents as a QC department subject matter expert (SME)
- support laboratory investigation of OOS/ invalid assays, CAPAs and change controls
- Ensuring accuracy and completeness of executed analytical method qualification, validation, and transfer activities
- Set testing priorities and manage work assignments
- Interpreting and enforcing all quality procedures for QC personnel. Ensure staff training qualification for the assigned activities and training completion in a compliant state
- Implementing quality control programs to ensure reliability of testing procedures, proper function of laboratory equipment, and compliance with applicable regulations.
- Preparing, approving and maintain applicable records. Develops and implements Quality related documents including control plans, visual aids, and work instructions. Recommends changes in specifications of materials, parts, and products based on inspection results. May formulate and revise quality control policies and procedures.
- Supporting in troubleshoots problems around quality to come up with solutions that are comprehensive and higher quality in investigation and follow-up. Reviews reports and confers with quality assurance, production, management, and engineering personnel to solve work-related problems.
- Ensuring the full compliance with the good documentation and data integrity practices.
- Effective participation in the regional/global forums (e.g. QC lab council…etc).
Main performance measures (Performance Goals)
- Compliant, efficient and on time release of raw materials, packaging components and finished goods.
- Compliant, efficient and on time equipment qualification and calibration.
- Compliant, efficient and on time completion of any CAPA related to the QC lab.
- Compliant, efficient and on time completion of the lab investigation accuracy and timeliness
- Compliant, efficient and on time response to the internal/external audit observations.
- Compliant, efficient and on time completion of the internal/external audit action plan.
- Effective and on time implementation of the team development plans
- Adherence to the approved lab budget.
- Adherence to the good documentation and data integrity practices.
Qualifications
Experience Required
- Education: A Bachelor’s degree or master’s degree or advanced degree (Ph.D.) in science or pharmacy
- Years of Experience: minimum of 5 years of managing QC laboratory with expert knowledge of analytical and microbiology technologies used in the QC laboratory
- Language: Fluent written and spoken English
- Location: Cairo, Egypt
- Relocation availability: Not required