Dalia Osama Abolfadl

Rameda

• Quality Compliance Unit HeadFull Time

  Jan 2023 - Present -2 yrs, 6 months

  Egypt , Giza

  • Job Details:Responsibilities: Execution of internal audit program on different company departments including GMP (e.g. sterile production, non-sterile production, QC, warehouse, etc…) and non-GMP departments (Engineering sector including HVAC, water station, maintenance & HR, scientific office, supply chain, EHS, etc,…) including performing of plan, notification with audit agenda, preparation of audit checklist according to cGMP ,ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018, reporting of internal audit non- conformities including categorization of risk levels, issuing, follow, closing and evaluate effectiveness of related CAPAs.  Handling of Risk Management System as a Risk Management Process Owner; including assuring that there is an established, implemented and maintained QRM system, Review and approve the risk assessment results and the proposed risk scoring before the final approval, Ensure that critical risk failure modes are adequately addressed and documented, Define membership of the “Risk Management and compliance Board” and provides leadership to the board, Measurement of action plan effectiveness, Approve the closure of risks & Conduct the "After Closure Review".  Handling and Investigation of customer Complaints; issuing, follow, closing and evaluate effectiveness of related CAPAs.  Handling of CAPA system including immediate action, approval for corrective & preventive actions, follow-up actions implementation and evaluate effectiveness of CAPAs after closing.  Handling of external audits and closing of related CAPAs which raised from different external audits either EDA inspection, export, toll manufacturing companies or certification.  Handling, reviewing & follow up Change Control System.  Handling of Deviation program; issuing, follow, closing and evaluate effectiveness of related CAPAs.  Execution of packaging material vendor qualification including vendor quality assessment, evaluation of the questionnaire, preparing annual risk assessment for each supplier, annual audit schedule, audit agenda, conducting audit at supplier site, prepare & send audit report, review and agree received CAPAs and then preparing quality agreement.  Routine compliance tour on different company departments including GMP (e.g. sterile production, non-sterile production, QC, warehouse, etc…) and non-GMP departments (Engineering sector including HVAC, water station, maintenance & EHS, etc,…).
• Quality Assurance Compliance Senior SpecialistFull Time

  Feb 2018 - Dec 2022 -4 yrs, 10 months

  Egypt , Giza

  • Job Details:Responsibilities: 1) Execution of internal audit program on different company departments including GMP (e.g. sterile production, non-sterile production, QC, warehouse, etc…) and non-GMP departments (Engineering sector including HVAC, water station, maintenance & HR, scientific office, supply chain, EHS, etc,…) including performing of plan, notification with audit agenda, preparation of audit checklist according to cGMP ,ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018, reporting of internal audit non-conformities including categorization of risk levels, issuing, follow, closing and evaluate effectiveness of related CAPAs, 2) Handling of CAPA system. 3) Handling and Investigation of Deviation program. 4) Handling and Investigation of customer Complaints. 5) Handling, reviewing & follow up Change Control System. 6) Preparation of external audits either EDA inspection, export, toll manufacturing companies or certification. 7) Routine compliance tour for GMP areas. 8) Participate in Risk Management System. 9) Participate in handling of external audit and closing of related CAPAs which raised from different external audits either export, toll manufacturing companies or certification bodies. 10) Participate in packaging material vendor qualification.