Shoab Malek (Certified Quality Auditor)

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Possess total 5+ years of experience in Production and QA Documentation , QMS , Validation & Qualification system. Having exposure of Solid Oral , SVP , LVP , Vaccine Production , API Production & Ointment / External Section. Currently under Employment With Galentic Pharma (India) Pvt. Ltd. as a Team Leader QA. Previously Worked under employment With Nabros Pharma Pvt. ltd. as a Sr. Executive QA. Previously Worked under employment With Hester Biosciences Ltd as a Sr. officer Production & Documentation Department. Also worked with Concord Biotech Limited, Dholka as a Production Chemist. Core Competency & Key Strengths:- Exposure Of Regulatory Audit & Complies. Handling of Internal...

pharmaceutical compliance documentation qa qms gmp risk management capa management auditor audit internal audit results critical process parameter process capsule tablet validation osd pv regulatory complait recall gdp entry - exit production sterile manufacturing quality gowning oos fda laboratory qc usfda glp claculations example protocol & report maco cleaning validation cgmp tqm five why fault tree analysis fisbone sharepoint

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Shoab Malek (Certified Quality Auditor)

Internal audit

Process validation of oral solid dosage form (tablet)

Complaints and recalls handling

Good documentation practice

Gowning procedure for Pharma Manufacturing Area

Good Laboratory Practice (GLP)

Cleaning validation

Total Quality Management & current Good Manufacturing Practice

Capa, root cause analysis, and risk management