Sunil Gulhane
Asst.Q A. Manager at Bliss GVS Pharma Ltd.
- Role
- Assistant Manager Quality Assurance at Bliss GVS Pharma Ltd.
- Location
- Amravati, MH, IN
- LinkedIn followers
- 500 followers
About Sunil Gulhane
I have an experience of 14+ years in Pharmaceutical Industry in Quality Assurance department.Monitoring the performance of team members to ensure efficiency in process operation and meeting of targets in the quality assurance department.Training of team members to ensure SOPs and cGMP regulation to be followed.Conducting internal audits to identify gaps in existing process(s), preparation of action plan, review and implementation of identified actions.Motivating, encouraging & developing skilful, effective and sustainable team.Work experience of preparation and review of quality management system SOPs.Wide knowledge of handling & ensuring of Quality Assurance for various dosage formulations as Oral Solid Dosage forms, Oral Liquid Dosage forms, Dry Syrups, Dry Powder for oral Suspension, Suppository & Pessaries and External preparations viz. Ointment, Creams, Gel, Lotion, Shampoo, Serum, etc
Experience
Assistant Manager Quality Assurance
Jun 2022 — Present · Mumbai, IN
Asst. Quality Assurance Manager (Section Head-QMS)•Drive compliance of plant as per QMS and regulatory expectations while seeking continuous improvement in cGMP to ensure regulatory requirement.•Analyse and review the non-conformances (Deviation, market complaints), change controls, incidents, OOS and product recalls. Lead and Monitor investigation and root cause identification.•Review of qualification protocols and reports related to equipment/instrument/ utilities/system.•Review of Site Master File, Validation Master Plan, Quality Risk Assessment, SOPs.•Perform Gap Analysis for alignment of procedures with practice and regulatory updates.•Plan regulatory compliance of audit observations.•Review and implement internal audits and ensure observation closing within timeframe.•Leading QMS, GMP, MRM and KRA meetings and presenting data.•Develop capability of team through training to aid them in performing their job roles better and conributing to achieving team goals.
Education
M. J. Jr. College Karanja (Lad)
HSC
2004
SGB Amravati University
Master of Pharmacy, Pharmacognosy
2013
SGB Amravati University
Bachelor of Pharmacy - BPharm
2010
New English High School Akola
SSC
2002
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