Krishna Pocha
Quality Assurance Manager at SANDOZ -QA-QMS-CSV-US FDA-EU-MHRA-US Visa B1/B2
- Role
- Manager at Sandoz India
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
About Krishna Pocha
With over 23 years of experience in the pharmaceutical industry, I have expertise in…
Experience
Manager
Jan 2024 — Present · Hyderabad, IN
Responsible for site remediation.Responsible for the Quality Management System at the SANDOZ Development Center- include, Training Management, Document Management, SOP Management, Quality Review Board, QMS (Deviation, Quality Event, OOX, Change Control, CAPA Data Trending), Equipment Qualification, Inspection Readiness Data Integrity & e-Compliance.Coordinates, leads, or participates in Corporate Quality Compliance Audits of Corporate Quality Management System across network sites, Contract facilities, Affiliates, and Critical Service providers, to assess compliance with all applicable regulations and to identify top compliance risks.Provides leadership toward calling out site and multi-site compliance issues resulting from audit findings. Active communication & Coordination with global site teams in Escalations.Implementing and monitoring Site Quality Plan, Data Integrity, Self-Inspection Plan.Serves as subject matter expert on global regulated requirements and inspectional commitments, as applicable.Proactively identify potential quality risks and work with relevant teams to implement CAPAs.Perform and guide document Life Cycle Pathway Mapping for Instrument and ProcessAnalyze QMS data to find the areas for improvement.
Education
Z.P.P.High School
High school, General stu
1982 — 1994
Acharya Nagarjuna University
Doctor of Philosophy (Ph.D.), Biotechnology
Devi Ahilya Vishwavidyalaya, Indore
Master of Science (M.S.), Pharmaceutical Chemistry
1998 — 2000
Sri Krishnadevaraya University
Bachelor of Science (B.Sc.), Organic Chemistry
1994 — 1997
Skills
- Pharmaceutical Industry
- Sop
- Glp
- High-Performance Liquid Chromatography (Hplc)
- Gmp
- Technology Transfer
- Pharmaceutics
- Drug Discovery
- Hplc
- Lc-Ms
- Life Sciences
- Analytical Chemistry
- Standard Operating Procedure (Sop)
- Pharmacokinetics
- Regulatory Affairs
- Chromatography
- Dmpk
- Validation
- Good Laboratory Practice (Glp)
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