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Resume alert |
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Vadodara, Gujarat, India
... ISO, FDA, WHO, GMP, USFDA and EDQM audit faced. Handling customer, FDA, WHO, GMP, third party and Vendor Audit. Prepare and review of BMR. CAPA, Change Control, Deviation, Customer Complaint. Vendor Audit and Internal audit. Analyzing the Incidents ...
- 2022 Jun 13
Vadodara, Gujarat, India
... FDA updates these guidelines time to time the provides to their users. All the FDA approves plants have to follow these FDA guidelines throughout the world.FDA provides the pharmaceutical guidelines for all the stages from raw material to finished ...
- 2021 Nov 15
Vadodara, Gujarat, India
... Tadalafil Handling solvent as follows, N Butyle lithium Xylene bromine Tolune Di chloro methane Acetonitrile Acetic acid N hexane Cyclohexane Dimethyl formide Acetone Ethyl acetate Tetra hydrofluron etc… Audit face USFDA- 3 times EDQM- 4 times FDA ...
- 2021 Aug 03
Vadodara, Gujarat, India
... OBJECTIVE An FDA approved Microbiologist seeking an oppotunity to work in an organisation where I can utilize my potential and expertise to the fullest and make a positive impact on an organization. WORK EXPERIENCE Qc Sr. Executive Nature of ...
- 2021 Jul 27
Vadodara, Gujarat, India
... Participate in several Regulatory Audit like, MHRA, USFDA, Ukraine Government Audit (SAUFD), TGA (Australia), Russian regulatory audit (MOH), Medicines Control Council of South Africa (MCC), Taiwan FDA, Belarus GMP inspection, GQA audit of Sanofi ...
- 2021 Jun 23
Vadodara, Gujarat, India
... • OOS/OOT/OOC/Incidents /Deviations/CAPA/Change Control • Stability study • Audits (US FDA -12, MHRA-9, EU (GMP) – 5, ISO 9001 – 1, WHO- (Geneva) -1 Includes sterile and non sterile regulatory audits. • SAP/ERP/LIMS/QMS /EDMS/LMS/EWS • Qualification ...
- 2021 Jun 12
Anand, Gujarat, India
... Topic delivered Basic of QF and Calculation of FDA Suggested Quality Indicators. 2018: GUJCOST sponsored national level one week STTP On “Qbd Academic And Industrial Perspective Organized by Department Of Pharmacy, Saurashtra University Rajkot, ...
- 2020 Feb 13
Vadodara, Gujarat, India
... In addition, SAETRS supports the generation of reports on all SAEs that are submitted to the FDA on a periodic basis Responsibilities: Responsible for the testing of Web applications on different platforms i.e. Windows, Mac and browsers i.e. Chrome, ...
- 2020 Jan 08
Vadodara, Gujarat, India
... TECHNICAL SKILLS Strong understanding of all aspect of the clinical monitoring and quality management process involved in BA/BE operations in accordance with ICH GCP, FDA Guidelines and in-house SOPs. Good hand on software’s like (CLIS& EDMS) ...
- 2019 Sep 07
Vadodara, Gujarat, India
... Periodically verify the effectiveness of CAPA for each failure or incident or observations or FDA committed CAPA to ensure that are being implemented effectively. Prepare, review trend analysis (Quarterly as well as Yearly) for Market Complaint / ...
- 2019 Jun 25