Middle East Africa Quality Improvement Senior Manager
GlaxoSmithKline Consumer Healthcare
مجموع سنوات الخبرة :16 years, 3 أشهر
1. Provide ongoing leadership, mentoring and support to Managers within the area for all compliance activities. Provide guidance on general quality matters.
2. Formulate inputs to annual Quality Plan including outcomes from management reviews, internal audits and external assessment such as regulatory inspections, corporate audits and findings.
3. Formulate inputs to Area Quality Council meetings and act as Chairperson when required
4. Lead Management Review of the quality systems performance through assessment and trending of performance indicators such as complaints, deviations, CAPA and Change Control.
5. Develop insights from KPIs and trending to drive continuous improvement initiatives in MEA
6. Take responsibility as project manager for MEA for new IT system implementation
7. Responsible for creating a MEA training plan and comprehensive training materials for successful delivery of training within LOCs, distributors and third parties. Responsible for the tracking of training and adherence to training plan.
8. Fulfill super user roles and responsibilities for AMA LOC Quality for IT systems including CARISMA 3, CDMS, mylearning and CERPs
9. Work with the global team to represent MEA within global network or global process improvement teams.
10. Support Risk Assessments for the MEA area.
11. Oversee the DRA process and escalate significant distribution risks to Q Council and RMCB.
12. Represent MEA during MEA SPOC for NPI projects to support portfolio simplification and deliver NPI innovations with proactive quality input
•Ensure implementation of GSK CH Quality Management System and GMP requirements at North Africa region
•Monitor and review performance of metrics against the targets and liaise periodically with General Managers and Regional Commercial heads to agree improvement areas
•Determine the responsibilities of LOC Quality Staff to ensure effective, overall quality management and continuous improvement of supply chain activities in LOCs
•Create and identify opportunities to share information, documentation and knowledge between LOCs and driving simplification and improvements.
•Ensure timely and effective escalation of quality incidents and provide the necessary analysis to understand and escalate issues which have the potential to impact supply or GSK’s reputation as a manufacturer of quality products and when necessary direct LOC’s to manage incidents via the PIRC process and take on the role of PIRC Chair for incidents relating to LOC Quality in North Africa region. Act as a coach/provide advice to the PIRC secretary and other PIRC chairs.
•Actively manage North Africa quality teams and set up their development and objective targets and develop a plan of support visits to LOCs based on people management needs and risk.
•Act as a quality contact for Supply chain and commercial teams as relevant in relation to quality and compliance issues
•Coordinate LOC and Distribution Center site readiness for Health Authority inspections and proactively manage interactions and commitments to HA.
•Ensure effective Quality Management of New Product Introduction, the distribution network in North Africa, complaint management, artwork management and ensure Duty of Care and Product release is conducted in line with local regulatory requirements
•Work in a matrix organization with the global documentation and systems group to ensure appropriate LOC Quality Global SOPs and processes are developed and then lead the implementation of the SOPs or process across the Middle East region.
1. Overseeing the maintenance and execution of the product release procedure used to release batches to market.
2. Ensuring that all OTC Release designates are adequately trained and qualified for perform batch release of OTC products and that a written procedure is available to describe release to market activities.
3. Investigate and document deviations associated with Novartis OTC products destined for the Egyptian market.
4. Perform duty of care release activities as required by the business according to the correct criteria as required by the product dossier and approved procedure.
5. 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.
6. Filing and storing batch documentation and retention samples.
7. Review final product batches for compliance to packaging requirements as per registered criteria and document the release activities for every batch.
8. Ensuring that a local Quality System and Standard Operating Procedures are in place for all GMP related activities and continuously ensuring that the local quality system is updated as required.
9. Ensure that a Change Control/Management procedure is in place.
10. Ensure that an Artwork Management Procedure is in place for the checking and approval of all Artwork at Novartis OTC Egypt.
11. Manage and co-ordinate third party activities and ensure that Novartis OTC Third Party Organizations (manufacturers and distributors etc.) are in compliance with local/Novartis expectations, and that they meet business objectives for compliance and supply.
12. Ensure Quality Assurance Agreements are in place.
13. Manage Internal Audits, Regulatory Inspections and Self-Inspections according to the Novartis Corporate Quality Manual and local written procedures and ensure implementation of corrective actions resulting from inspections by Health Authorities, Group Quality Assurance and internal inspections.
14. Overseeing the handling of incoming customer complaints and ensure that the OTC QA Associates are adequately trained in handling and managing local customer complaints.
15. Review the trending of incoming customer complaints and report trends at the OTC Quality Review Board meeting.
16. Review all QA investigations on site.
17. Identify and record all applicable Corrective and Preventative Actions. Ensure that Corrective and Preventative Actions are tracked to completion.
18. Manage recalls according to the Novartis Corporate Quality Manual and local written procedures.
19. Inform the Business Unit Head and recall committee of recalls and document the relevant aspects of a recall.
20. Manage and maintain a GMP training plan and program for Novartis OTC GxP personnel in Egypt.
21. Ensure that all CAPAs are tracked to completion in a timely manner.
22. Implement the annual Novartis Quality Plan.
23. Execute the annual Country Organization Risk Assessment for Novartis OTC Egypt and FAMAG.
24. Execute the annual Country Quality Risk Assessment for all local Novartis Third Party Organizations in Egypt.
25. Execute Novartis QA projects (as required by Novartis from time to time).
26. 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.
27. Establish a good working relationship with the Supply Chain Management (SCM) and DRA departments, as well as the Nyon Exports group for FAMAG countries.
28. Ensure that coordinated contact is maintained with the local partners (suppliers, third parties, licensees, distributors) and Global Quality Operations/Country Management.
29. Maintain, conduct and minute the quarterly Site Quality Committee meetings for Egypt and FAMAG and assist the Nyon export group with QA queries and request for product distributed in FAMAG countries.
1. Aid in Human Resource Development, Follow Lilly Performance Management system for evaluation and skill development of my team in the Microbiology quality control laboratory. Assist in the resolution of HR issues.
2. Responsible for the adjusting merit increase and provides inputs that supports decisions regarding compensations and benefits to my team.
3. Manage microbiology department budget and assist in the management of the Quality department budget. Track and report resource requirements for budget development associated with the quality control microbiology laboratory team.
4. Participates in organizational planning, development of business plan for area of responsibility.
5. Creates and maintains microbiology laboratory operational goals metrics for effectiveness and efficiency, as well as maintains and reports current KPIs and trend charts.
6. Mentor, coach and/or provide feedback to employees.
7. Day-to-day Supervision of microbiology laboratory employees performing testing and support activities, including scheduling of work assignments based on priorities, ensuring accuracy and timeliness of testing and data.
8. Evaluate new equipment for purchase and assures that laboratory equipment is maintained calibrated and / or qualified and in good working condition, and purchases supplies and equipment
9. Evaluates suppliers and service providers for the labs. Manage lab contracts with external parties.
10. Serve as a conduit for corporate communications to Microbiology team.
11. Participate in self-led and/or agency inspections in the Microbiology laboratory.
12. Make sure all microbiology laboratory staff is trained and qualified prior to performing assigned tasks and assignments independently.
13. Develop procedures and schedules to ensure that all routine processes and methods utilized by the laboratory are valid for the materials under test according to applicable cGMP’s and applicable regulatory and pharmacopeia requirements
14. Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site goals. Ensure that Environment, health and safety standards are maintained.
15. Ensure that the methods and procedures utilized are current and strictly followed.
16. Ensure all laboratory activities are compliant to applicable cGMP’s, global quality standards requirements and applicable pharmacopoeia requirements
17. Review and monitor the performance of utilities, bulk drug product, raw material, and finished product testing for, bioburden, and / or bacterial endotoxin, so that all testing to support the production and release of product lots is performed in compliance to local procedures, global quality standards and external regulatory standards and pharmacopoeias.
18. Review and monitor the performance of environmental monitoring, validation sample testing, and growth promotion testing assuring testing is performed in compliance to internal procedures and standards and external regulatory standards.
19. Reviews and approves microbiological test results for environmental monitoring, raw materials, bulk and finished drug products, growth promotion, and validation testing
20. Reviews and approves microbiological investigations, change controls, protocols and validation reports
21. Writes, updates, reviews, and / or approves microbiology laboratory Standard Operating Procedures, Analytical Methods and Specifications as appropriate.
22. Remain current on upcoming technologies and regulations and recommend as appropriate and when feasible to improve efficiency, cost, or productivity.
23. Having the technical knowledge and the capability of performing all tasks within the lab in case of issues with resources, including sterility, particulate, endotoxin, growth promotion, antimicrobial effectiveness, bioburden, crystallization, and microbial identification testing.
1- Provide the required quality assurance support to Parenteral Products production and products customized or packaged in Lilly Egypt Manufacturing Facility.
2- Maintain quality systems and GMP compliance and provide assistance and guidance in nonconformance investigations, utilities, equipment and computer systems, change control proposals, complaints handling, procedure and master formula revisions, validations, batch dispositions, annual product review, periodic quality evaluations, commissioning and qualifications.
3- Keep, Ensure site is always ready for inspection in addition to preparation for audits and inspections by various regulatory agents Ensure regular presence in operational areas to ensure compliance to quality systems and GMP in addition to continuous improvement.
4- Participate in self inspections and/or corporate and agency inspections of the manufacturing.
5- Ensure current procedures are reflecting the requirements in the different standards & drive the efforts to close the gaps if any
6- Drive the gap assessment activities needed for any new requirement & leverage the competency for the needed skills.
7- Ensure the sites remains current with the changes in the industry / regulations.
8- Drive the efforts needed to improve quality of technical reports.
9- Follow the training conformance of the employees, enhance the effectiveness of the training system, approve the qualification protocols for the critical GMP duties for different departments.
10- Site sterility assurance and compliance expert .
1. Perform all laboratory activities according to applicable cGMPs, global quality standards requirements and applicable pharmacopoeia requirements.
2. Perform testing of finished product for bacterial endotoxin, crystallization check, preservative efficacy test according to the European pharmacopeia for the stability of manufactured product.
3- Perform growth promotion for all types of media, microbiological enumeration, D-value studies and spike control qualification for biological indicators, microbiological identification using Vitek2 compaq system, morphological and microscopical examination of all different types of microorganisms.
4-Develop equipment qualification protocols as well as participating in development and/or execution of equipment validation packages
5. Deals with suppliers regarding purchasing lab material and negotiates for better offers.
6. Deals and coordinates with service providers for the preventive maintenance, requalification and calibration of lab. equipment
7- Create and review procedures and methods generated in the lab.
8- Initiate OOS reports, change controls and deviations in the Trackwise System.
9- Train, qualify and mentor others, develop training material including qualification protocols.
10. Generate microbiological test results for environmental monitoring, raw materials, bulk and finished drug products, growth promotion, validation testing and recording results
obtained in the designated forms.
11. Collect results and perform trending of environmental monitoring data
1-Environmental monitoring activities for both sterile and non sterile areas
2-Microbial limit test for solid, semisolid and liquid dosage forms
3-Antibiotic assay for Neomycin
4-Growth promotion for all types of media
5-Water sampling and analysis
6- Identification of microorganisms isolated from different areas
7-Backup for Sterility and Endotoxin testing for sterile products
8-Production and laboratory autoclave validation
9-Reviewing and updating laboratory SOPs and methods
10-Training of new analysts on different microbiological methods
Certified manager of quality / operational excellence