Quality Assurance Senior Officer Jobs In Egypt And Career In Novartis Pharma Vacancies In Cairo 2014
Job ID 134434BR
Position Title Quality Assurance Senior Officer
Division Over The Counter
Business Unit Over The Counter
Country Egypt
Work Location Cairo
Company/Legal Entity Egypt Novartis Egypt (Healthcare) S.A.E., Amiria, Cairo
Functional Area Production
Job Type Full Time
Employment Type Regular
Job Description Job Purpose
Provide leadership for all QA activities associated with the Novartis OTC products manufactured and distributed in Egypt market. With principle focus performing on market release of OTC products to the Egyptian market to meet the needs of the business, ensuring compliance with the required local Egyptian regulation and Novartis quality and compliance requirements. Acts as the first point of contact for all Quality inquiries in this market to assure the quality of OTC products.
Major Accountabilities
Market release
-Perform all the activities needed to release Novartis OTC products to the Egyptian market in a timely manner and according to the correct criteria as required by the product dossier and approved procedure
-Obtaining and reviewing the necessary documentation and batch data\samples to ensure its compliance before performing Market release for the products on SAP as per the laid out standard operation procedure.
-Filing and storing batch documentation and retention samples.
-Review final product batches for compliance to packaging requirements as per registered criteria.
-Document the release activities for every batch.
-Order and maintain reference standard stock for the purpose of Post Importation Testing.
-Initiate and oversee Analytical Method Transfers to relevant local testing laboratory.
Ensure compliance with Novartis Quality Systems
-Ensure that all aspects of the operational business comply with cGMP, legal and regulatory requirements and with the Novartis Pharma Corporate Quality Manual and Policies
-Provide support to the Head of Quality Assurance to ensure that quality systems are established, implemented and maintained within the Organisation.
-Support the implementation and maintenance of the different Quality systems.
-Product Quality Reviews (PQR):
Compile the annual Product Quality Review Plan in conjunction with the QA Head.
Obtain the relevant PQR reports from the manufacturing sites.
Compile the local PQR report and review all local data in conjunction with the manufacturing site PQR report.
Ensure APR/PQR process is managed in accordance with the Novartis Quality Manual requirements for all products manufactured by local TPO whenever applicable
-Ensure compliance with the local procedures and Novartis Quality Manual within the assigned areas.
-Review and follow up investigations of deviation and\or customer complaints to ensure its effectiveness and completion with the defined time lines
-Ensure implementation of CAPAs and compliance records to ensure proper completion and closure on time
-Participate in the assessment and evaluation of risks for the existing Quality processes and systems and provide recommendations and solutions to close gaps and ensure sustained compliance with the Corporate Quality Manual and local procedures requirements.
-Ensure quality oversight for GxP activities by performing periodic reviews of KPI's and preparing follow-up reports.
-Assist Head Quality Assurance in the execution of the yearly quality management review
-Write all SOP’s and work instructions and ensure congruence with good manufacturing practice (GMP)and Novartis quality manual Manage their update and approval
-Manage archive ensuring systems are in place for effective record keeping and updating
-Provide support to all activities associated with product recalls according to the Novartis Corporate Quality Manual and local procedures.
-Support assessment and recording of all incoming customer complaints on the system (CRTS) and report Customer Complaints to the relevant Manufacturing Sites and Follow-up with investigation sites to ensure timely closure according to Novartis Customer Complaint Timelines.
-Ensure that all artwork is checked for QA relevant points, before approval.
-Audits and Self-Inspection Management:
Participate in the execution of self-inspections as per the self-inspection annual plan.
Provide support to external inspections of Novartis OTC operations, according to the Novartis Corporate Quality Manual and local written procedures.
Ensure implementation of corrective actions resulting from inspections by Health Authorities, Group Quality Assurance and self-inspections.
-Provide support in the preparation to the local QRB meetings and present relevant QA topics from time to time.
-Provide the necessary data for the monthly reporting.
Key Interactions:
•OTC QA Head,
•Novartis Pharma plant specifically QA group
•OTC Supply chain group
•OTC DRA within the assigned areas.
Minimum requirements Education:
•Pharmacy Degree
Languages:
•Good command of English (spoken & written)
•With excellent communication and negotiation skills (oral and written). Business working knowledge of an Arabic language desired.
Experience:
3-5 year’s relevant experience in the Pharmaceutical industry including Quality Assurance and Quality Control.
Experience in Batch documentation review and release
Experience in using quality compliance tracking systems and document management systems
Experience in change control, customer complaint, deviation and CAPA management
Experience in conducting investigation and root cause analysis
Good knowledge of Quality Systems with strong technical knowledge and hands on experience of GMP requirements associated with pharmaceutical production.
Experience of the manufacturing environment with demonstrated ability to interpret and implement international pharmaceutical GMP requirements.
Possess a strong attention to details with record of driving quality performance in a commercial environment while maintaining a quality-focused attitude.
Good working knowledge of Microsoft office with demonstrated skills in the use of information management systems in a GxP environment (e.g. Trackwise, SAP).
Apply Here :
https://sjobs.brassring.com/tgwebhost/selectresume.aspx?SID=^Rw/XYcRvtE6uMDY7dKMKwwuqFhEAdPMrwW/XWl7yPLSeqhrq_slp_rhc_qfOLwAgUHZHD4ai&calledFrom=ProfileProvider
Job ID 134434BR
Position Title Quality Assurance Senior Officer
Division Over The Counter
Business Unit Over The Counter
Country Egypt
Work Location Cairo
Company/Legal Entity Egypt Novartis Egypt (Healthcare) S.A.E., Amiria, Cairo
Functional Area Production
Job Type Full Time
Employment Type Regular
Job Description Job Purpose
Provide leadership for all QA activities associated with the Novartis OTC products manufactured and distributed in Egypt market. With principle focus performing on market release of OTC products to the Egyptian market to meet the needs of the business, ensuring compliance with the required local Egyptian regulation and Novartis quality and compliance requirements. Acts as the first point of contact for all Quality inquiries in this market to assure the quality of OTC products.
Major Accountabilities
Market release
-Perform all the activities needed to release Novartis OTC products to the Egyptian market in a timely manner and according to the correct criteria as required by the product dossier and approved procedure
-Obtaining and reviewing the necessary documentation and batch data\samples to ensure its compliance before performing Market release for the products on SAP as per the laid out standard operation procedure.
-Filing and storing batch documentation and retention samples.
-Review final product batches for compliance to packaging requirements as per registered criteria.
-Document the release activities for every batch.
-Order and maintain reference standard stock for the purpose of Post Importation Testing.
-Initiate and oversee Analytical Method Transfers to relevant local testing laboratory.
Ensure compliance with Novartis Quality Systems
-Ensure that all aspects of the operational business comply with cGMP, legal and regulatory requirements and with the Novartis Pharma Corporate Quality Manual and Policies
-Provide support to the Head of Quality Assurance to ensure that quality systems are established, implemented and maintained within the Organisation.
-Support the implementation and maintenance of the different Quality systems.
-Product Quality Reviews (PQR):
Compile the annual Product Quality Review Plan in conjunction with the QA Head.
Obtain the relevant PQR reports from the manufacturing sites.
Compile the local PQR report and review all local data in conjunction with the manufacturing site PQR report.
Ensure APR/PQR process is managed in accordance with the Novartis Quality Manual requirements for all products manufactured by local TPO whenever applicable
-Ensure compliance with the local procedures and Novartis Quality Manual within the assigned areas.
-Review and follow up investigations of deviation and\or customer complaints to ensure its effectiveness and completion with the defined time lines
-Ensure implementation of CAPAs and compliance records to ensure proper completion and closure on time
-Participate in the assessment and evaluation of risks for the existing Quality processes and systems and provide recommendations and solutions to close gaps and ensure sustained compliance with the Corporate Quality Manual and local procedures requirements.
-Ensure quality oversight for GxP activities by performing periodic reviews of KPI's and preparing follow-up reports.
-Assist Head Quality Assurance in the execution of the yearly quality management review
-Write all SOP’s and work instructions and ensure congruence with good manufacturing practice (GMP)and Novartis quality manual Manage their update and approval
-Manage archive ensuring systems are in place for effective record keeping and updating
-Provide support to all activities associated with product recalls according to the Novartis Corporate Quality Manual and local procedures.
-Support assessment and recording of all incoming customer complaints on the system (CRTS) and report Customer Complaints to the relevant Manufacturing Sites and Follow-up with investigation sites to ensure timely closure according to Novartis Customer Complaint Timelines.
-Ensure that all artwork is checked for QA relevant points, before approval.
-Audits and Self-Inspection Management:
Participate in the execution of self-inspections as per the self-inspection annual plan.
Provide support to external inspections of Novartis OTC operations, according to the Novartis Corporate Quality Manual and local written procedures.
Ensure implementation of corrective actions resulting from inspections by Health Authorities, Group Quality Assurance and self-inspections.
-Provide support in the preparation to the local QRB meetings and present relevant QA topics from time to time.
-Provide the necessary data for the monthly reporting.
Key Interactions:
•OTC QA Head,
•Novartis Pharma plant specifically QA group
•OTC Supply chain group
•OTC DRA within the assigned areas.
Minimum requirements Education:
•Pharmacy Degree
Languages:
•Good command of English (spoken & written)
•With excellent communication and negotiation skills (oral and written). Business working knowledge of an Arabic language desired.
Experience:
3-5 year’s relevant experience in the Pharmaceutical industry including Quality Assurance and Quality Control.
Experience in Batch documentation review and release
Experience in using quality compliance tracking systems and document management systems
Experience in change control, customer complaint, deviation and CAPA management
Experience in conducting investigation and root cause analysis
Good knowledge of Quality Systems with strong technical knowledge and hands on experience of GMP requirements associated with pharmaceutical production.
Experience of the manufacturing environment with demonstrated ability to interpret and implement international pharmaceutical GMP requirements.
Possess a strong attention to details with record of driving quality performance in a commercial environment while maintaining a quality-focused attitude.
Good working knowledge of Microsoft office with demonstrated skills in the use of information management systems in a GxP environment (e.g. Trackwise, SAP).
Apply Here :
https://sjobs.brassring.com/tgwebhost/selectresume.aspx?SID=^Rw/XYcRvtE6uMDY7dKMKwwuqFhEAdPMrwW/XWl7yPLSeqhrq_slp_rhc_qfOLwAgUHZHD4ai&calledFrom=ProfileProvider
