ziad mohammed fathy

Quality Assurance Section HeadFull Time

• Job Details: Ensure the obedience of national and international regulations, professional and extra-professional norms as well as rules of ethics and good behavior as defined by the company.  Assist in deployment of Otsuka Global Quality Standards within the function. Assess new or revised standards, conducting gap analysis to local procedures, and support alignment activities for deployment.  Handling of all potential and/or existing risks through documentation, immediate notification, assessment, control, communication and review of risks with proper escalation and approval in a timely manner for maintaining product quality & protection of the patient (overall goal).  Lead and participate in project teams to implement Quality Management Systems including but not limited to implementation of Deviation Management process, Customer Complaints, Change Controls, CAPAs, Risk Assessment Document Control and Vendor qualification related procedures.  Supporting in Management Review Meetings.  Support in root cause analysis for quality system trends; recommend actions to address trends.  Where appropriate, drive improvements to correct or prevent negative trends.  Assess deviations and non-conformance with regards to level of risk to product quality.  Execute and support the audit program, including; customer audits, supplier audits, internal audits and un-announced regulatory audits.  Developing a rolling internal audit plan for the site based on a comprehensive assessment of risks, relying where possible on management’s assessment, considering maintenance of a high level of strategic foresight by identifying audit client and business needs and recommending internal audit plan changes accordingly.  Responsible for implementing of the Business Continuity Planning (ISO 22301).  Issuance of Site Master File/Quality Manual.  Responsible for providing input to APQRs as per the agreed schedule. This includes completion of APQR chapters to support creation of the product specific APQR report.  Review validation and qualification documents.  Review of Specifications & Test Methods of Materials & Products.  Leads meaningful projects and guiding teams that will impact the production of globally recognized branded products like Pleetal, Abilify, Mucosta FCT.  Contribute to the identification of opportunities for continuous improvement of systems, processes and practices taking into account Regulation and customer requirements', improvement of business processes, cost reduction and productivity improvement.  Manage local budget at CAPEX/OPEX levels in Quality Assurance with company targets.  Manage team of subordinates to ensure that all work activities are carried out in an efficient and procedural compliant manner.  Track and trend performance of quality systems and prepare, present status reports for key performance indicators to management.  Keen on analytical judgments, good decision-making abilities, good resolution of issues, good organizational skills and attention to detail.

ComplianceFull Time

• Job Details:Lead and coordinate the daily duties and responsibilities of all subordinates within two departments "Audits and cGMP follow-up". 2) Assign the deputy policy, considering that activities only "not responsibilities" can be delegated. 3) Prepare the monthly report about the Section activities and introduce it to the Quality Assurance Manager. 4) Identify resources (e.g. guidelines, standards, laws …etc) required to ensure good job performance. 5) Conduct continual training program and recommend appropriate qualification courses, as per required. 6) Review and appraise the performance of subordinates. 7) Carry out all relevant duties assigned by Quality Assurance Manager.

QA SpecialistFull Time