Sarang Vyawahare
Assist. Manager Quality Assurance
Parbhani
Summary
To work in a challenging atmosphere that provides me ample opportunity for learning, growth and to work for achieving organizational goals. I believe in the magic of teamwork and I wish to give my best to the organization for which I work.
Overview
9
9
years of professional experience
8041
8041
years of post-secondary education
6
6
Certifications
3
3
Languages
Work History
Asst. Manager QA (IPQA In-Charge)
Edkem Pharmaceuticals Ltd
12.2024 - Current
- Batch creation, Batch release & Batch Closure in Pharma-Cloud Software
- Allocate daily work / area to IPQA team member & Shift schedule
- (10 Team Members)
- Review of all Master BMR & BPR
- Training Co-ordinator
- Monitor shop floor activity
- Production planning in pharmacloud as and when required
Sr. Executive QA (IPQA)
Zydus Lifesciences
09.2020 - 11.2024
- Document review
- Issuance of documents
- Line clearance and Visual in 'CLEEN' software
- To perform In-process activities in manufacturing area
- Weight variation
- Disintegration Test
- Friability Test
- Hardness Test
- Release, Impact assessment, Verification & Closing of memo in SAP
- Verifying & Approval of labels, cartons & leaflets at packing stage
- LIMS – To send Intimation regarding samples to QC (at Inspection stage)
- System audit trial of Inspection machine (Sensum & Enclony)
- Facility Inspection as & when required
- Taking swab sample as per given protocol
- Handling of E-logbook (currently not in operation)
- Performing Pre-AQL of tablets at Inspection stage
- Performing start and end challenge test at Inspection stage
- Verifying data logger report at Inspection stage
- Participated as a QA team member in USFDA audit
Executive - CQA
BDR Pharmaceutical International Pvt. Ltd.
06.2019 - 09.2020
- Batch record review
- APQR review
- Preparation / Review / Revision / Approval of SOP
- Communicate to various site for documents / certificates related to Vendor such as Vendor information form, GMP Certificates, Residual solvent Certificates, TSE/BSE Certificates
- Preparation / updating of qualified vendor list
- Coordinate with QC for preparation of specifications as per vendor COA
- Coordinate between F&D, QC & Other sites for tech transfer related documents such as Master record to prepare BMR & BPR
- Specification prepared as per vendor COA by coordinating with QC Department
- Process Validation protocols prepared by coordinating with F&D Department
- Stability protocol prepared by coordinating with QC Department
- Visiting sites with an auditor as a representative of the company
- Visited below mentioned facilities with the auditor
- (From Live Anahita Pharmed, Iran)
- Cadchem, Chandigarh
- Lyka Labs, Ankleshwar
- Virdev Intermediate, Surat
Executive QA (Documentation)
R N Laboratories Pvt. Ltd.
01.2019 - 06.2019
- Assisting QA Head during audit as a team member
- Prepare required documents as per audit agenda
- Intimate all department about audit agenda
- Assisting QA Head for audit compliance report preparation
- Preparation / Review / Revision / Approval of SOP
- BPCR Review
- Handling customer audit
- Handled customer audit as a team leader
- (Quality Executive - QP Watson Limited, London, UK.)
Assistant Officer QA (Documentation)
Ajanta Pharma Limited
12.2016 - 01.2019
- Review & Release of Final Batch Record
- APQR Preparation
- IPQA in Liquid Formulation Department
- Document Issuance & Retrieval
- Audit compliance at site & reporting to Head QA
- Participated as a QA team member in Kenya, Uganda, WHO audits
Junior Officer IPQA
Indoco Remedies Ltd
02.2016 - 12.2016
- To carry out in process quality checks at various levels in the plant
- To certify appropriate and timely line clearance at various stages in the plant
- To report risk related to product, process and system to Head QA
- To review online documentation i.e
- BMR, BPR, Log Books, Calibration records, Daily/ Weekly cleaning records etc
- In the concerned department
- To highlight the online problems/ Non Conformances with respect to procedures, specifications, SOP, cGMP etc
- On day to day basis
- To withdraw and submit samples of Bulk, Finished product, Validation as per mentioned in protocol
- Participated as a QA team member in Namibia, Tanzania & WHO audits
Education
M. Pharmacy -
Yash Institute Of Pharmacy
B. Pharmacy -
Yash Institute Of Pharmacy
H.S.C. -
Bal Vidya Mandir Junior College
S.S.C. -
Bal Vidya Mandir Junior College
Skills
MS-Office (Word, Excel, Power point)
LIMS 340
SAP
CLEEN Software
Minitab
Pharmacloud Software
Certification
AIGPE Lean Six Sigma White Belt Certification
Areas Of Interest
- Data Integrity
- Compliance
Activities
Isolation, New method development and Structural elucidation of antioxidant compound in Arachis Hypogaea. Linn skin extract., IIT, Powai, Isolation and New method development of antioxidant compound in Arachis Hypogaea Linn, College of Pharmacy, Sonai, Ahmednagar, Eco-friendly validated spectroscopy method for the estimation of glicazied in bulk using hydrotropy, Poona College of Pharmacy, Erandwane, Pune, Novel low cost gelatin based microfluidic device for estimation of n-octanol-water partition coefficient, Amity University, Noida, Delhi, Current trends in pharmaceutical sciences, Dr. Vedprakash Patil Pharmacy College, Aurangabad
Personal Information
- Category: General
- Father's Name: Mr. M.M. Vyawahare
- Date of Birth: 01/16/89
- Nationality: Indian
- Marital Status: Unmarried
- Religion: Hindu
Disclaimer
I hereby declare that all the statements made in this resume are true and complete to the best of my knowledge and belief., 04/10/25, Ahmedabad
Timeline
Asst. Manager QA (IPQA In-Charge)
Edkem Pharmaceuticals Ltd
12.2024 - Current
Sr. Executive QA (IPQA)
Zydus Lifesciences
09.2020 - 11.2024
Executive - CQA
BDR Pharmaceutical International Pvt. Ltd.
06.2019 - 09.2020
Executive QA (Documentation)
R N Laboratories Pvt. Ltd.
01.2019 - 06.2019
Assistant Officer QA (Documentation)
Ajanta Pharma Limited
12.2016 - 01.2019
Junior Officer IPQA
Indoco Remedies Ltd
02.2016 - 12.2016
M. Pharmacy -
Yash Institute Of Pharmacy
B. Pharmacy -
Yash Institute Of Pharmacy
H.S.C. -
Bal Vidya Mandir Junior College
S.S.C. -
Bal Vidya Mandir Junior College
Similar Profiles
JACKSON JOYJACKSON JOY
Assistant Manager - Projects at Acino Pharmaceuticals FZ LLC (erstwhile Pharmax Pharmaceuticals FZ LLC)Assistant Manager - Projects at Acino Pharmaceuticals FZ LLC (erstwhile Pharmax Pharmaceuticals FZ LLC)
LENORA MERKEYLENORA MERKEY
Senior Therapeutic Specialist at Sumitomo Pharma America Pharmaceuticals, SMPA (Formerly Sunovion Pharmaceuticals)Senior Therapeutic Specialist at Sumitomo Pharma America Pharmaceuticals, SMPA (Formerly Sunovion Pharmaceuticals)
PATRICIA S. GANTERTPATRICIA S. GANTERT
Principle Quality Specialist at Endo Pharmaceuticals/ Auxilium PharmaceuticalsPrinciple Quality Specialist at Endo Pharmaceuticals/ Auxilium Pharmaceuticals
Krishna MangwaniKrishna Mangwani
Intern at Tactical Cyberange Simulations Pvt.LtdIntern at Tactical Cyberange Simulations Pvt.Ltd
Kalyani KaleKalyani Kale
Medical Officer at Golden City HospitalMedical Officer at Golden City Hospital