Quality Assurance Specialist At Sandoz Egypt
-Manages Quality aspects and projects within area of responsibility.
-Ensures and supports overall GxP conformity and Compliance with the Quality Management Systems
-Ensure that Change requests are managed according to the SOPs from receipt, through to the implementation and closure.
-Conduct GxP monitoring on all sections, conduct QA investigation for noncompliance, Follow up the corrective actions.
-Archive relative documentations.
-Coordinate implementation of quality system and procedures for the implementation of Quality Manual and quality agreements.
-Ensure that all aspects of the handling and distribution of pharmaceutical products in the country comply with the requirements of the Quality Manual and Policies and meet all relevant cGMP regulatory and legislative requirements. -Ensure that a local Quality System and Standard Operating Procedures are in place for all cGMP/GDP related activities and that compliance with cGMP/GDP regulations is maintained through training and internal audits.
-Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that technical support on all quality related matters is provided to the country.
-Establish a good working relationship with the Supply Chain Management (SCM), DRA and Medical departments.
-Ensure that coordinated contact is maintained with the Regulatory Authorities, the local partners (suppliers, third parties, licensees, and distributors) and Global Quality Assurance.
-Ensure that all incoming drug products are inspected prior to release to the market in accordance with the current in place procedures, registered specifications and with local/international regulations.
-Ensure that an effective Change Control process is in place.
-Manage complaints, recalls, counterfeits and product tampering according to the Corporate Quality Manual and local written procedures.
-Support / participate in NEM cases as required.
-Reporting of technical complaints / adverse events / special case scenarios related to products within 24 hours of receipt
-Distribution of marketing samples (where applicable)
-FU & monitor KQIs and assure that gaps are addressed appropriately in order to mitigate risk
-Maintain current knowledge of local and international regulatory and legislative requirements and trends.
-Establish a good working collaboration with business partners.
-Ensure NCQ readiness for all GxP regulatory inspections & Manage inspections for all GxP as required and ensure relevant CAPAs have been completed/closed for related areas.
-Take accountability for escalation of process non-compliance
-Identify key risks in relation to regulatory compliance through Self Inspection.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Pharmacist with 3-5 years of experience in Quality Assurance