Jelena Jovanovic
Quality Assurance ManagerAccelsiors CRO and Consultancy Service
Serbia and Montenegro, Serbia and Montenegro
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Professional Experience
Sep 2007 - Present
Quality Assurance Manager
Employed
Accelsiors CRO and Consultancy Service
Pharmaceuticals
Employed
Accelsiors CRO and Consultancy Service
Pharmaceuticals
-Establishing and management of a fully functional QA Unit,
-Acting as a representative of the Company Quality Assurance in the interface with the Sponsor Quality Assurance representatives, Quality Assurance Auditors, Governmental Inspections,
-Working on jobs of the GCP compliance : quality manual, policies, standard operating procedures, study related plans (including development of quality plan for certain study), GCP training, audits, corrective and preventive action.
-Acting as a representative of the Company Quality Assurance in the interface with the Sponsor Quality Assurance representatives, Quality Assurance Auditors, Governmental Inspections,
-Working on jobs of the GCP compliance : quality manual, policies, standard operating procedures, study related plans (including development of quality plan for certain study), GCP training, audits, corrective and preventive action.
Mar 2004 - Sep 2007
(3 years, 6 Months)
(3 years, 6 Months)
QA Associate -> Senior QA Associate -> Independent Expert Associate in GMP Compliance Deparmen
Hemofarm
Pharmaceuticals
Hemofarm
Pharmaceuticals
Working on jobs of the GMP compliance:
- Change control ,
- Corrective and preventive action,
- Deviation management,
- Complaints and recalls from the market - GMP training
- Audits and Inspections and - Good Documentation Practice,
Working on projects:
- Project of Qualification on Injections Plant and Microbiological Laboratory in order to prepare for the FDA inspection, - Project of implementation of the SAP business suite (SAP R/3 and SAP-BW) according to Hemofarm’s needs on sites: Hemofarm A.D. Vrsac, Panfarma and Multivita. Role: Validation team member, - Project of implementation of the SAP business suite according to Hemofarm’s needs on site Obninsk, Russia– Roll out and Optimization of the system at Hemofarm. Role: Validation team member.
- Change control ,
- Corrective and preventive action,
- Deviation management,
- Complaints and recalls from the market - GMP training
- Audits and Inspections and - Good Documentation Practice,
Working on projects:
- Project of Qualification on Injections Plant and Microbiological Laboratory in order to prepare for the FDA inspection, - Project of implementation of the SAP business suite (SAP R/3 and SAP-BW) according to Hemofarm’s needs on sites: Hemofarm A.D. Vrsac, Panfarma and Multivita. Role: Validation team member, - Project of implementation of the SAP business suite according to Hemofarm’s needs on site Obninsk, Russia– Roll out and Optimization of the system at Hemofarm. Role: Validation team member.
Education
2003
M.Sc.Pharm., Univerzitet u Beogradu
More about Jelena Jovanovic
First Name
Jelena
Last Name
Jovanovic
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