Quality Manager
Macro Group pharmaceuticals
Total des années d'expérience :23 years, 8 Mois
1. Manages the Quality Control department daily work activities including: workload, ensuring training, general guidance to direct reports and across functional groups, and serves as resource for technical / administrative problems.
2. Hires, trains, motivate leads, develop and evaluate staff. Takes corrective action as necessary on a timely basis and in accordance with company policy.
3. Ensures compliance with current state and local regulations.
4. Ensures Quality Control systems are compliant with corporate and site procedures, as well as industry standards.
5. Interacts with suppliers during meetings and visits
6. Works in conjunction with other departments to develop, qualify, and transfer QC analytical methods.
7. Ensures maintenance of QC equipment - qualification, calibration and maintenance.
8. Participates in Validation Team and Project Teams, as applicable.
9. Drafts, reviews, and approves Standard Operating Procedures (SOP), sampling plans, specifications, protocols and reports related to product/processes, equipment, method, validation. This includes deviation investigation and reporting.
10. Develops and implements statistical tools for Quality Systems monitoring and review.
11. Participate in the study of any changes to critical processes, facilities, equipment and systems through the change control program to assess impact on validated systems.
12. Assists in supplier / regulatory audits and responding to audit observations and corrective actions.
13. Identifies and implements improvement opportunities for established Quality Systems, processes, procedures, and training to support CAPA, Change Control, Deviation, Risk Management, and Investigation processes.
14. Collaborates significantly with cross functional groups, including QA, Validation, Manufacturing, Process Development, Facilities, and Regulatory Affairs.
15. Provides technical assistance and training for personnel
16. Files and maintains controlled documents.
17. Other duties as assigned
Full Analysis of HPLC & dissolve its Troubleshoots products & Stability & validation study Department
Equipment HPLC (Agilent, Waters, shimadzu ), Melting point, I.R (shimadzu), UV Spectrophotometer (shimadzu, Jenway), Karl Fischer, Viscometer(Brookfield), Disintegration Apparatus ( Varian ), Dissolution apparatus( Varian, hanson ), Refractive index, Polarometer(Atago), friability, Hardnees
Ensuring tests and procedures are properly understood, carried out and evaluated and that product modifications are investigated if necessary
Update and maintain all master SOP’s
Evaluates and approves current and new vendors of raw material and packaging material in cooperation with purchasing staff to establish quality requirements from external active pharmaceutical ingredients suppliers.
Increase the QC teams awareness in the drug manufacturing process by establishing internal and external training programs that shall target critical areas to ensure integration of quality in every production function
Full Analysis of HPLC & dissolve its Troubleshoots products & Stability study Department
Equipment HPLC (Agilent, Waters, shimadzu ), Melting point, I.R (shimadzu), UV Spectrophotometer (shimadzu, Jenway), Karl Fischer, Viscometer(Brookfield), Disintegration Apparatus ( Varian ), Dissolution apparatus( Varian, hanson ), Refractive index, Polarometer(Atago), friability, Hardnees
Ensuring tests and procedures are properly understood, carried out and evaluated and that product modifications are investigated if necessary
Full Analysis of HPLC & dissolve its Troubleshoots products & Methodology Department
Full Analysis of HPLC & dissolve its Troubleshoots products & Methodology Department
M.Sc. of Organic Chemistry ( 2012 )
Analytical Biochemistry Diploma ( 2007 )
B.Sc. Zoology & chemistry (2000)