QA Manager
Riva Pharm
مجموع سنوات الخبرة :16 years, 4 أشهر
1. Coordinate and supervision the subordinates and reviewing their reports.
2. Approve the annual audit plan (Internal & External).
3. Internal & External auditing team leader.
4. Handling and implement the internal, outdoor audit and external audits and issuing the relevant
reports according to approved plan.
5. Approval of QA, validation & Compliance SOPs for relevant tasks.
6. Checking and implementation of cleaning validation protocols its risk assessments reports and final
approval for the final study reports.
7. Approve of products validation protocols and its final reports.
8. Approve qualification protocols (facilities & equipment) reports/protocols (DQ, IQ, OQ, and PQ).
9. Approve of other department SOPs to be complying with the corporate policy.
10. Participation and preparing for any external audit e.g. (MOH Authorities & under license, etc) and
preparing the replying report and follow up for their observations.
11. Check and following all ISO documents and requirements in the site every year.
12. Reviewing of deviation reports, Out of specification investigation, and determined the appropriate CAPA
and follow up the execution.
13. Approve of investigation reports and change requests for all change action plan at site.
14. Handling with any recall according to the recall procedure and monitoring the mock recall for
evaluation our competency.
15. Final reviewing for Complaints reports and assuring the CAPAs were taken and implemented.
16. Approve for calibration plan, preventive maintenance plan, VMP.
17. Responsible for supplier qualification and evaluation according to supplier plan.
18. EH&S committee Head of RIVA Pharma Egypt.
19. Devising and establishing a company's quality procedures, standards and specifications.
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20. Reviewing customer requirements and ensuring that they are met.
21. Coaching & evaluating QA team
22. Setting standards for quality as well as health and safety.
23. Making sure that manufacturing or production processes meet international and national standards.
24. Defining quality procedures in conjunction with operating staff.
25. Setting up and maintaining Document Management system
26. Monitoring performance by gathering relevant data and producing statistical reports.
27. Final Batch Release
28. Follow up applying cGMP.
29. Management of the Internal Audit system، Vendor assurance and supplier auditing.
30. Management of the GMP Training System.
31. Management of the Validation system.
32. Performance monitoring and review.
33. Management of the Risk Management process.
1. Assures consistent quality of production by developing and enforcing good automated manufacturing practice systems; validating processes; providing documentation; managing staff.
2. Responsible for inspecting procedure and outputs and identifying mistakes or non-conformity issues.
3. Works with other staff within organization to determine and establish procedures and quality standards and to monitor these against agreed targets.
4. Lead a IMC to maintain continuous product or service quality by implementing process controls, data analysis and measurement devices.
5. Monitor processes and goods at every stage to ensure they remain in an acceptable state; a final release for any shipment related to IMC or any relevant agent according to Shipment Release System.
6. Handling all cosmetic & Pharmacovigilance reports with IMC partners and according to MOH guidelines.
7. Transfer the official acknowledgement statements of Anticorruption and Anti-bribery inside IMC.
8. Devising and establishing a company's quality procedures, standards and specifications.
9. Reviewing customer requirements and ensuring that they are met.
10. Setting standards for quality as well as health and safety.
11. Defining quality procedures in conjunction with operating staff.
12. Setting up and maintaining Document Management system
13. Monitoring performance by gathering relevant data and producing statistical reports.
14. Meets quality assurance financial objectives by estimating requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions.
15. Develops quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories.
16. Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures.
17. Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints.
18. Collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods.
19. Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
20. Updates job knowledge by studying trends in and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
21. Enhances department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
22. Determining, negotiating and agreeing on in-house quality procedures, standards and specifications.
23. Assessing customer requirements and ensuring that these are met.
24. Setting customer service standards.
25. Specifying quality requirements with suppliers.
26. Investigating and setting standards for quality and health and safety.
27. Insuring that manufacturing processes comply with standards of IMC.
28. Working with operating staff to establish procedures, standards system complying with reference guidelines.
29. Writing management and technical reports and customers ‘charters.
30. Determining training needs.
1. Devising and establishing a company's quality procedures, standards and specifications.
2. Reviewing customer requirements and ensuring that they are met.
3. Coaching & evaluating QA team.
4. Setting standards for quality as well as health and safety.
5. Making sure that manufacturing or production processes meet international and national standards.
6. Defining quality procedures in conjunction with operating staff.
7. Setting up and maintaining Document Management system.
8. Monitoring performance by gathering relevant data and producing statistical reports.
9. Final Batch Release.
10. Follow up applying cGMP.
11. Management of the Internal Audit system، Vendor assurance and supplier auditing.
12. Management of the GMP Training System.
13. Management of the Validation system.
14. Performance monitoring and review.
15. Management of the Risk Management process.
& Compliance Section Head:
1. Coordinate and supervision the subordinates and reviewing their reports.
2. Preparing the annual audit plan (Internal & External).
3. Internal & External auditing team leader.
4. Handling and implement the internal, outdoor audit and external audits and issuing the relevant
reports according to approved plan.
5. Reviewing and approval of QA, validation & Compliance SOPs for relevant tasks.
6. Checking and implementation of cleaning validation protocols its risk assessments reports and final
approval for the final study reports.
7. Check and approve of products validation protocols and its final reports.
8. Check and approve qualification protocols (facilities & equipment) reports/protocols (DQ, IQ, OQ,
and PQ).
9. Full delegation for reviewing and approval of other department SOPs to be complying with the
corporate policy.
10. Participation and preparing for any external audit e.g. (Bayer, J&J, TAKEDA, etc) and preparing the
replying report and follow up for their observations.
11. User of SAP system.
12. Preparing and following all ISO documents and requirements in the site every year.
13. Reviewing of deviation reports, Out of specification investigation, and determined the appropriate
CAPA and follow up the execution.
14. Delegated from the manager in reviewing and approval of investigation reports and change requests
for all change action plan at site.
15. Handling with any recall according to the recall procedure and monitoring the mock recall for
evaluation our competency.
16. Final reviewing for Complaints reports and assuring the CAPAs were taken and implemented.
17. A member in the team which dedicated for FDA project.
18. Checking and approval for calibration plan, preventive maintenance plan, VMP.
19. Responsible for supplier qualification and evaluation according to supplier plan.
20. EH&S committee member at HIKMA Egypt with direct reporting to EH&S director.
Compliance & Validation
(2 years 1 month) At HIKMA Pharma Egypt; (Senior Compliance).
1- Preparation of Deviation reports with appropriate CAPA and Change control action plan.
2- Participation in Internal & External auditing team.
3- User of SAP system.
4- Participation in team for ISO requirements in the site every year.
5- Variances (Deviation and incident) investigator.
6- Recall & mock recall procedure.
7- Complaint investigator.
(I.P.C Team Leader) at HIKMA Pharmaceutical Industry
Company, responsible for:
1. Responsible for cGMP implementation in whole production (dispensing, solid, liquid, semisolid and
packaging areas).
2. Responsibility for all quality and compliance requirements, and local regulatory guidelines policies
and procedures.
3. Implementation systems related to documentation, annual product review, complaints, market
actions and product release.
4. The disposition of damaged, quarantined and customer returned products.
5. Ensuring maintenance of environmental conditions, and records as per local and company
requirements.
6. Attendance & Sharing of all the Preparations Solid, Semisolid, and Liquid with a very good back ground
about all operations and Techniques of each area.
7. Assisting in deviation Investigation and Change Protocol Plan.
8. Batch Release (full authority).
9. Perform IPC testing for the different operation in the production area.
10. User of SAP system.
11. Participation in team for ISO requirements in the site every year.
12. SOP Preparation and reviewer.
13. A trainer member at summer for the pharmacies students based on our training plan.
14. Daily check at Warehouse and Water Station.
15. Sharing as a member in internal & external auditing team.
16. Highly knowledgeable about all production sections as a part of my tasks.
Faculty of Pharmacy, 6th October University (Grade: Very Good 80%).