QA – Compliance Supervisor
Job Description
Follow up the status of all CAPAs raised from different sources such (audits, complaints, and deviations) Also coordinating, supervising, managing and Executing compliance activities related to internal and external audits.
Essential Tasks:
Maintain of the CAPA system and follow up all CAPAs raised from different sources such: internal/ external audits, complaints, deviations.
Handle risk management process including risk identification, analysis, evaluation and risk control and identify residual risks and their evaluation.
Participate in the internal audit conduction for the activities and departments assigned.
Cooperate with audit team for full filling the audit system objective and company yearly objectives.
Participate in the external audit assigned to (off site) for suppliers and sites of toll manufacturing and subcontractors.
Follow up on compliance related tools in the QMS with relevant company departments with the scope of implementation for standards and GMP guidelines.
Report audit findings and follow up whatever necessary for successful cycle completion and Reports the checklist and audit findings for the external visits (off site visit) as per auditing annual plan, then issues annual auditing activities reports and reporting the outcomes.
Participate and report assigned tasks as per quality risk projects.
Collect and gather data for the management review.
Participate in quality agreements drafting as per relevant system SOPs.
Coordinate with related departments for the system continual improvement, conduct annual review for planned actions for its effective implementation by company departments.
Use lean tools and six sigma approaches and methodologies for monitoring and opportunity identification for process improvement.
Participate in opportunities identification as per Orchidia licensed standards and report them, perform and report the progress status in the annual reviews.
Coordinate with CE team to implement project activities and, primarily, handle all reporting, logistical coordination, operational work, and provides assistance in day to day program activities
Participate in following up technical file preparations according to MDD 93/42/EEC and the new MDR regulation 2017/745 and EC regulatory requirements.
Perform periodic review for GMP of WHO / MHRA / FDA guidelines updates and legal regulations as requested by the department manager.
Work through, follow and adhere to safety instructions and requirements.
Work according to GLP, GMP and GDP rules.
Shall be consulted and participated in the EHS management system and its improvement elements.
Skills
Bachelor’s degree in pharmaceutical sciences or science.
From 5 to 8 years of experience in pharmaceutical industry and operations.
Evidence on technical development and trainings for GMP guidelines and ISO standards.
Lean tools and six sigma previous experience in implementation or participate in the process.
Auditing skills and behavior need to be demonstrated as significant part of the job onsite and offsite auditing.
Previous use of Minitab® is preferable.
Previous work with an ERP system is preferable.
Understanding of methodologies and best quality assurance practices.
Knowledge of documentation reviews and requirements analysis.
Ability to work well through others.
Excellent English, verbal / written communication.
Excellent computer skills.
Education
Pharmaceutical Science or Science
Job Location Cairo, Egypt Job Role Manufacturing Years of Experience Min: 5 Max: 8 Residence Location Cairo, Egypt
