Quality Assurance Senior Officer QS and 3rd party manufacture role Jobs In Egypt And Career In Novartis Pharma Vacancies In Cairo 2014
Job ID 134435BR
Position Title Quality Assurance Senior Officer QS and 3rd party manufacture role
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 on providing QA oversight of the manufacture of Novartis products at Third Party manufacturers to ensure the quality and compliance of the manufactured products and ensuring compliance with the required local regulation and Novartis quality and compliance requirements. Acts as the first point of contact for all Quality inquiries of the third party manufacturers in this market to assure the quality of OTC products meets Novartis standards as defined in the Novartis Quality Manual.
Major Accountabilities
Third Party manufacturing QA oversight
-Ensure compliance of Third Party manufacturers, manufacturing Novartis OTC products with Novartis Quality and GMP requirements
-Review and approve stability and validation protocols/reports,
-Participate and follow up investigations and root cause analysis of deviation and\or customer complaints to ensure its effectiveness and completion with the defined time lines
-Follow up on implementation of CAPAs and compliance records to ensure proper completion and closure on time
-Review products stability data, annual product reviews, procedures and change control documents.
-Provide support on all quality/GMP matters raised by the Novartis OTC third party manufacturing for OTC within the assigned Operating Unit.
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
-Participate as a representative of the Quality Assurance in projects / issues.
-Provide support to the Head of Quality Assurance to ensure that quality systems are established, implemented and maintained within the Organisation.
-Support the update of the different Quality systems and verify that they are applied and ensure that all activities are performed according to the local Quality System and SOP’s.
-Management and follow up of the implementation and timely closure of compliance records, Corrective and Preventative Actions (CAPA’s), deviations change controls and complaints.
-Support the product quality review (PQR) activities in accordance with the approved procedure and schedule.
-Ensure quality oversight for outsourced 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
-GMP training:
Manage and maintain a GMP training plan and program.
Execute GMP training where required.
-Provide support to all activities associated with product recalls according to the Novartis Corporate Quality Manual and local procedures.
-Ensure all complaints are recorded, investigated and closed in a timely manner into the Global OTC complaints database. Ensure customer enquiries & complaints are regularly reviewed and trended to identify opportunities for improvement.
-Customer Complaints:
Assess and record all incoming customer complaints on the system (CRTS) and report Customer Complaints to the relevant Manufacturing Sites.
Follow-up with investigation sites for Customer to ensure timely closure according to Novartis Customer Complaint Timelines.
Trend customer complaints.
- Management and maintenance of Standard Operating Procedures
-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,
•Third Party manufacturing sites within the assigned area.
•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 managing QA at Third Party Manufacturing operations.
Demonstrated experience in equipment and process Validation
Experience in quality management system change control, customer complaint, deviation and CAPA management
Experience in conducting investigation and root cause analysis
Demonstrated experience in process Validation
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=^fv0/k5rGEWhb6EXNr6qzRTsx_slp_rhc_g72wXFtaGfkS9K_slp_rhc_tT/b8YNltLGAHuQl9thOYZMl&calledFrom=ProfileProvider
Job ID 134435BR
Position Title Quality Assurance Senior Officer QS and 3rd party manufacture role
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 on providing QA oversight of the manufacture of Novartis products at Third Party manufacturers to ensure the quality and compliance of the manufactured products and ensuring compliance with the required local regulation and Novartis quality and compliance requirements. Acts as the first point of contact for all Quality inquiries of the third party manufacturers in this market to assure the quality of OTC products meets Novartis standards as defined in the Novartis Quality Manual.
Major Accountabilities
Third Party manufacturing QA oversight
-Ensure compliance of Third Party manufacturers, manufacturing Novartis OTC products with Novartis Quality and GMP requirements
-Review and approve stability and validation protocols/reports,
-Participate and follow up investigations and root cause analysis of deviation and\or customer complaints to ensure its effectiveness and completion with the defined time lines
-Follow up on implementation of CAPAs and compliance records to ensure proper completion and closure on time
-Review products stability data, annual product reviews, procedures and change control documents.
-Provide support on all quality/GMP matters raised by the Novartis OTC third party manufacturing for OTC within the assigned Operating Unit.
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
-Participate as a representative of the Quality Assurance in projects / issues.
-Provide support to the Head of Quality Assurance to ensure that quality systems are established, implemented and maintained within the Organisation.
-Support the update of the different Quality systems and verify that they are applied and ensure that all activities are performed according to the local Quality System and SOP’s.
-Management and follow up of the implementation and timely closure of compliance records, Corrective and Preventative Actions (CAPA’s), deviations change controls and complaints.
-Support the product quality review (PQR) activities in accordance with the approved procedure and schedule.
-Ensure quality oversight for outsourced 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
-GMP training:
Manage and maintain a GMP training plan and program.
Execute GMP training where required.
-Provide support to all activities associated with product recalls according to the Novartis Corporate Quality Manual and local procedures.
-Ensure all complaints are recorded, investigated and closed in a timely manner into the Global OTC complaints database. Ensure customer enquiries & complaints are regularly reviewed and trended to identify opportunities for improvement.
-Customer Complaints:
Assess and record all incoming customer complaints on the system (CRTS) and report Customer Complaints to the relevant Manufacturing Sites.
Follow-up with investigation sites for Customer to ensure timely closure according to Novartis Customer Complaint Timelines.
Trend customer complaints.
- Management and maintenance of Standard Operating Procedures
-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,
•Third Party manufacturing sites within the assigned area.
•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 managing QA at Third Party Manufacturing operations.
Demonstrated experience in equipment and process Validation
Experience in quality management system change control, customer complaint, deviation and CAPA management
Experience in conducting investigation and root cause analysis
Demonstrated experience in process Validation
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=^fv0/k5rGEWhb6EXNr6qzRTsx_slp_rhc_g72wXFtaGfkS9K_slp_rhc_tT/b8YNltLGAHuQl9thOYZMl&calledFrom=ProfileProvider
