Nawaj siddique - Pharmacist/ IPQA/ QA - Nashik, Maharashtra, India

Mohd Wasim Nawaj siddique

Nashik, Maharashtra, India

Services

Pharmacist/ IPQA/ QA

Summary:

IPQA Activites, QA Documentation.

Work History

Sr. Chemist-IPQA

Mylan Laboratories Ltd

From July 2013

PRESENT JOB PROFILE:Presently working as an IPQA officer:
• Performing IPQA activity of Tablets and Capsules.• Review of BMRs.
• Performing In-process, Validation, Cleaning validation and Hold Study sampling.
• Implementation of cGMP and SOPs at production shop floor and reporting non-compliance.
• Coordinating various validation and qualification activities.
PREVIOUS JOB PROFILE:Previously worked as a VALIDATION TEAM member
• Planning and Execution of Process-Validation and Product Hold Study of Tablets Capsules, Dry Syrup.
• In-process sampling during manufacturing of validation batches, performing challenges, Compilation & preparation of Validation reports and their review.
• Preparation of Validation Protocols, Reports, Hold-time study Protocols their correction & record keeping.
• Preparation of APQR (Annual Product Quality Review) and Retrospective validation Reports.
• Equipment & Process Equivalency study.
• Handling of Pest-control and other GMP Contract Records and Review.
• Equipment Qualification, HVAC-qualification.
• BMR & BPR issuance & their record keeping.• Reporting to Head-QA
AUDIT EXPOSURE:
Regulatory Audit Exposure: WHO, Kenya, Uganda, Botswana Iraq, Yemen, Bangladesh and Malawi, MHRA, USFDA, Congo.
cGMP Audit Exposure: Pfizer, MSD, GSK, ISAI Pharma, USV, Abott Ltd., SAVA Medica Ltd., AstraZeneca, Ranbaxy, Unichem, Glenmark Pharmaceuticals India Ltd., Bayer Pharma, Mylon Pharma India Ltd., Dr. Reddy's Laboratories.
COMPANY PROFILE:Hetero Labs Limited, Baddi
Regulatory Approvals: A WHO approved facility Approved for export in countries like Uganda (ANADA Uganda), Bangladesh, Yemen, Malawi, Kenya and Botswana.
MNC Clients: Pfizer, MSD, UCB, GSK, ISAI Pharma, USV, Abott Ltd., SAVA Medica Ltd., AstraZeneca, Ranbaxy, Unichem, Glenmark Pharmaceuticals India Ltd.
Domestic Clients: Cipla, Bayer, Zydus, Alkem Laboratories Ltd., Dr. Reddy's, Hetero Health care Ltd., Piramal Healthcare, Mankind Pharma, Lupin Ltd., Genex Pharma...

Officer-QA

Hetero Labs Limited

May 2011 - June 2013

PRESENT JOB PROFILE:Presently working as an IPQA officer:
• Performing IPQA activity of Tablets and Capsules.• Review of BMRs.
• Performing In-process, Validation, Cleaning validation and Hold Study sampling.
• Implementation of cGMP and SOPs at production shop floor and reporting non-compliance.
• Coordinating various validation and qualification activities.
PREVIOUS JOB PROFILE:Previously worked as a VALIDATION TEAM member
• Planning and Execution of Process-Validation and Product Hold Study of Tablets Capsules, Dry Syrup.
• In-process sampling during manufacturing of validation batches, performing challenges, Compilation & preparation of Validation reports and their review.
• Preparation of Validation Protocols, Reports, Hold-time study Protocols their correction & record keeping.
• Preparation of APQR (Annual Product Quality Review) and Retrospective validation Reports.
• Equipment & Process Equivalency study.
• Handling of Pest-control and other GMP Contract Records and Review.
• Equipment Qualification, HVAC-qualification.
• BMR & BPR issuance & their record keeping.• Reporting to Head-QA
AUDIT EXPOSURE:
Regulatory Audit Exposure: WHO, Kenya, Uganda, Botswana Iraq, Yemen, Bangladesh and Malawi, MHRA, USFDA, Congo.
cGMP Audit Exposure: Pfizer, MSD, GSK, ISAI Pharma, USV, Abott Ltd., SAVA Medica Ltd., AstraZeneca, Ranbaxy, Unichem, Glenmark Pharmaceuticals India Ltd., Bayer Pharma, Mylon Pharma India Ltd., Dr. Reddy's Laboratories.
COMPANY PROFILE:Hetero Labs Limited, Baddi
Regulatory Approvals: A WHO approved facility Approved for export in countries like Uganda (ANADA Uganda), Bangladesh, Yemen, Malawi, Kenya and Botswana.
MNC Clients: Pfizer, MSD, UCB, GSK, ISAI Pharma, USV, Abott Ltd., SAVA Medica Ltd., AstraZeneca, Ranbaxy, Unichem, Glenmark Pharmaceuticals India Ltd.
Domestic Clients: Cipla, Bayer, Zydus, Alkem Laboratories Ltd., Dr. Reddy's, Hetero Health care Ltd., Piramal Healthcare, Mankind Pharma, Lupin Ltd., Genex Pharma...

Officer- IPQA

Crest Healthcare Pvt. Ltd

July 2010 - May 2011

PRESENT JOB PROFILE:Presently working as an IPQA officer:
• Performing IPQA activity of Tablets and Capsules.• Review of BMRs.
• Performing In-process, Validation, Cleaning validation and Hold Study sampling.
• Implementation of cGMP and SOPs at production shop floor and reporting non-compliance.
• Coordinating various validation and qualification activities.
PREVIOUS JOB PROFILE:Previously worked as a VALIDATION TEAM member
• Planning and Execution of Process-Validation and Product Hold Study of Tablets Capsules, Dry Syrup.
• In-process sampling during manufacturing of validation batches, performing challenges, Compilation & preparation of Validation reports and their review.
• Preparation of Validation Protocols, Reports, Hold-time study Protocols their correction & record keeping.
• Preparation of APQR (Annual Product Quality Review) and Retrospective validation Reports.
• Equipment & Process Equivalency study.
• Handling of Pest-control and other GMP Contract Records and Review.
• Equipment Qualification, HVAC-qualification.
• BMR & BPR issuance & their record keeping.• Reporting to Head-QA
AUDIT EXPOSURE:
Regulatory Audit Exposure: WHO, Kenya, Uganda, Botswana Iraq, Yemen, Bangladesh and Malawi, MHRA, USFDA, Congo.
cGMP Audit Exposure: Pfizer, MSD, GSK, ISAI Pharma, USV, Abott Ltd., SAVA Medica Ltd., AstraZeneca, Ranbaxy, Unichem, Glenmark Pharmaceuticals India Ltd., Bayer Pharma, Mylon Pharma India Ltd., Dr. Reddy's Laboratories.
COMPANY PROFILE:Hetero Labs Limited, Baddi
Regulatory Approvals: A WHO approved facility Approved for export in countries like Uganda (ANADA Uganda), Bangladesh, Yemen, Malawi, Kenya and Botswana.
MNC Clients: Pfizer, MSD, UCB, GSK, ISAI Pharma, USV, Abott Ltd., SAVA Medica Ltd., AstraZeneca, Ranbaxy, Unichem, Glenmark Pharmaceuticals India Ltd.
Domestic Clients: Cipla, Bayer, Zydus, Alkem Laboratories Ltd., Dr. Reddy's, Hetero Health care Ltd., Piramal Healthcare, Mankind Pharma, Lupin Ltd., Genex Pharma...

Qualifications & Certifications

B.Pharmacy

Uttar Pradesh Technical University

Intermediate

PNGIC Ramnagar, Varansi/ UP Board

PNGIC Ramnagar, Varansi/ UP Board

Institute of Pharmaceutical Education & Research

Punjab Technical University

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