Quality Assurance Manager
Resume:
CURRICULUM VITAE
SOHIL. S. KHOJA
***, ****** **-********* *******
Sai Nagar, Near Jalaram Bapa Mandir,
N.H.No. 8, Vapi 396191
Dist. Valsad, Gujarat.
India.
Email Id.: **********@*****.**.**
Cell No. : 092********
ACCOMPLISHMENTS:
. Exposure To International Quality Standard Requirements:
The Experience Of Various Job Involves Preparation, Implementation And
Monitoring Of Quality Assurance System In The Organisation That
Includes Preparation, Implementation Of Standard Operating Procedures
(SOPs) Related To Quality Assurance, Quality Control, And Production
Department Through Training And Practice And In Process Quality
Checks.
. International And National Quality Audit Exposures:
. WHO - Geneva And Other Audits From Tanzania Etc. By Various
Marketing Authorisation Holders Of Regulated And Non Regulated
Markets At Umedica Laboratories Limited, Vapi (From December 2001
To March 2004).
. MHRA - UK, MCC - South Africa Audits Of The Cephalosporin -
Manufacturing Facility (Injectables, Tablets, Capsules & Dry Syrup)
& WHO Audit Of Both General And Cephalosporin Product Manufacturing
Facility At Alkem Laboratories Limited, Daman (From March 2004 To
August 2005)
. Exposure to WHO, ANVISA, GCC, UKARINE Audits And Other Audits i.e.
From Sudan. Also Faced USFDA for the ANDA Batches Manufactured
(Formulation I) At Wockhardt Biotech Park Waluj Aurangabad (From
August 2005 To May 2006)
. Exposure to UKARINE Audit, IDMA Audit, WHO Audit, MHRA Audit And
USFDA Audit At Ipca Laboratories Limited, Piparia Silvassa. (From
May 2006 To Feb. 2009).
. Exposure to MCC Preinspection Audit, NAFDAC Nigeria Audit, Malawi
Poison Board, Malawi Audit, USFDA Audit For Pot. Iodide Section and
Other Non Regulatory And Party Audits At SKant Healthcare Limited,
Vapi. (From Feb. 2009 Till Date).
MAJOR JOB RESPONSIBILITIES HANDLED:
. Handling Of Data Control Systems:
. Preparation And Control Of SOPs:
. Auditing Of Batch Processing Documents:
. Annual Product Quality Review:
. Handling Of Market Complaint:
. Process Validation:
. Equipment Qualification:
. Training Development:
. Site Master File Preparation:
. Validation Master File Preparation:
. HVAC Qualification:
. Compressed Air Validation:
. Cleaning Validation:
. Review of Analytical Report:
. CAPA Management:
. Self Inspection:
. Management Review Report:
. Release of Finished Product:
. Vendor Qualification:
. Change Control Management:
PREVIOUSLY ADDRESSED FOLLOWING;
. Autoclave Validation:
. Tunnel Validation:
. Aseptic Media Filling:
. ANDA
Handling ANDA Related Work Like: Preparation of Protocol For
Optimization Batch, Qualification Batch, Exhibit Batch, Process
Validation Batches, Hold Time Validation, Compilation Of Report With
Conclusion And Summary. Preparation Of Documents For Submission To
Regulatory.
. Others
Process Capability Study, Toxicological Data In Context With Cleaning
Validation, Dixon Test For Averaging Of The Result During Out Of
Specification, Gap analysis For The Equipment And Material During
Product Transfer, Review Of Water Validation Data, Stability Study
Data, Etc.
PROFESSIONAL EXPERIENCE (TOTAL NINE YEARS EIGHT MONTH):
. Presently Working With Skant Healthcare Limited Vapi, (From Feb. 2009
Till Date) As Asst. Manager, Faced USFDA, Pre Inspection From MCC,
Pfizer, Cipla, Mission Pharma, (NAFDAC) Nigeria, Malawi. Department
working under two section IPQA and QA documentation and reporting to
me. I Hold The Core Responsibility Of The Batch Release And As A Lead
Auditor. (For ISO 14001-2004 Executive EMS).
. Earlier Worked With Ipca Laboratories Limited, Piparia (From May 2006
To Feb. 2009). This Plant Is Approved By WHO, MHRA And USFDA. This
Plant Is Involved In Manufacturing Of ANDA Products. This Site Has The
Other Approval From Ukraine Ministry Of Health. Ipca Piparia Also
Faced IDMA Audit And Received Gold Medal For "Excellence In Pharma
Manufacturing". Lastly, Successfully Completed MHRA Audit And USFDA
Audit. All The Basic Responsibility With Respect To IPQA Reporting And
QMS.
. Earlier Worked With Wockhardt Biotech Park Situated At Waluj
Aurangabad (From August 2005 To May 2006) looking after In process
Quality Assurance During Manufacturing Of Formulation of Insulin
Injection (Both Cartridges and Vials). Controling the Approved Art
work From The Respective Parties (i.e. Chile). Preparation Of Batch
Manufacturing Record, Batch Packing Record, Process Validation
Protocols, Annual Product Quality Review, Batch Record Reviewing. This
Plant Is Approved By WHO, ANVISA, GCC And Approval Of USFDA (ANDA
Product (Formulation II).
. Previously Worked With Alkem Laboratories Ltd. Amaliya Daman (From
March 2004 To August 2005) As Officer In Quality Assurance Department.
The Cephalosporin Range Tablets, Capsules, Dry Syrup, And Injection
Manufacturing Facility At This Location Is Being Approved By MHRA -
UK, MCC South Africa And WHO. It Also Has Other Manufacturing Facility
For Betalactum And Generic Product Both Approved By WHO.
. Previously Worked With Umedica Laboratories Ltd. GIDC Vapi (From Dec.
2001 To March 2004) As Officer In Production And QA. Tablets, Capsules
And Injection At This Plant Is Approved By WHO.
PROFESSIONAL QUALIFICATION:
. Bachelor Of Pharmacy From Rajiv Gandhi University Of Health Science
(RGUHS) Bangalore Karnataka With First Class.
PERSONAL PROFILE:
. Date Of Birth : 03. 11. 1978
. Marital Status : Married
. Language Spoken : English, Hindi, Gujarati
. Computer Literacy : Microsoft Word, Microsoft Excel
VARIOUS TRAINING SESSIONS ATTENDED:
. Attended USP 5TH Annual Scientific Meeting For 3 Days At Hyderabad.
. "TQM (Total Quality Management)" Training For 3 Days By Mr. Mohammed
Ismail At Silvassa
. "Train The Trainers" Training For 3 Days By Mr. K.K.Mottoo At Mumbai
. Training On "Life-cycle & risk based approach to pharmaceutical
validation" For 3 Days By Mr. C.K.Moorthy At Hyderabad
The Details Furnished Above Are corrects To Best Of My Knowledge. Awaiting
Your Prompt Reply.
Regards,
Sohil Khoja (Assistant Manager)
Quality Assurance.
Skant Healthcare Limited, Vapi
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