Manju Maladinni

QA Manager

Mumbai, Maharashtra, India18 yrs 11 mos experience
Most Likely To SwitchHighly Stable

Key Highlights

  • 19 years of experience in pharmaceuticals
  • Expertise in Quality Management Systems
  • Six Sigma Green Belt certified
Stackforce AI infers this person is a Quality Assurance expert in the pharmaceutical industry.

Contact

manjumaldinni@gmail.comLinkedIn

Skills

Core Skills

Quality AssuranceQuality ManagementDecision-makingRoot Cause AnalysisInternal AuditsLeadershipValidation

Other Skills

Quality SystemQuality AuditingQuality ControlInvestigationTeam LeadershipPlanning and OrganizationVendor ManagementInterpersonal SkillsCommunicationProblem SolvingTrend AnalysisTrainingSix Sigma Green BeltAnalytical SkillsData Analysis

About

I have 19 years of rich experience in various reputed pharmaceuticals - Kopran, Dr Reddy, Ciron Drugs & Pharmaceuticals, Roquette India etc. Excellent leadership with multicultural team, expertise in Quality management system, Green belt certified - SPC deployment, Harmonization of site practices, Audit and compliance, Quality Risk Management in USFDA, EU, TGA, SAHPRA, Health Canada & MHRA approved plant.

Experience

18 yrs 11 mos
Total Experience
2 yrs 8 mos
Average Tenure
3 yrs 2 mos
Current Experience

Kopran ltd

2 roles

Quality Assurance Manager

Promoted

Jan 2024 – Present · 2 yrs 4 mos · On-site

  • Market complaint, Internal audit, Change control management, Deviation management, OOS, Root cause analysis & CAPA, Annual Product quality review, MRM, Audit & compliance , Quality Risk management & Quality improvement
Quality AssuranceQuality ManagementQuality SystemQuality AuditingQuality Control

Assistant Manager QMS

Feb 2023 – Dec 2023 · 10 mos · On-site

  • Change control management, Deviation management, CAPA, APQR & Risk assessment
Decision-MakingInvestigationRoot Cause AnalysisTeam LeadershipPlanning and Organization

Ciron drugs & pharmaceuticals pvt. ltd.

Audit and compliance - Quality Assurance

May 2021 – Feb 2023 · 1 yr 9 mos · Mumbai, Maharashtra, India

  • Vendor qualification, MRM, Change management, OOS, Trend analysis, Internal audit & compliance
Internal AuditsInvestigationQuality AssuranceVendor ManagementRoot Cause AnalysisInterpersonal Skills+1

Dr. reddy's laboratories

Team Lead Microbiology

Nov 2017 – May 2021 · 3 yrs 6 mos · India · On-site

  • Handling EM excursion, QMS, BET & MLT Method validation, Investigation, Root cause analysis, CAPA implementation & effectiveness check
InvestigationLeadershipProblem SolvingQuality AssuranceRoot Cause AnalysisTrend Analysis+1

Roquette india pvt ltd

Sr Executive Quality Assurance

Jan 2013 – Nov 2017 · 4 yrs 10 mos · Gokak, Karnataka, India

  • Equipment qualification, Process validation, cleaning validation, AHU qualification , process capability & Annual Product quality review, Hygiene awareness & Internal audit
Vendor ManagementSix Sigma Green BeltValidationCommunicationDecision-MakingInternal Audits+3

Riddhi siddhi gluco biols ltd.,

Executive QC Microbiology

Jan 2009 – Dec 2012 · 3 yrs 11 mos · Gokak, Karnataka, India · On-site

  • SOP preparation, MLT, Bioburden, EM monitoring, water analysis & COA
Analytical SkillsData AnalysisTrend Analysis

Vijaykant dairy and food products limited

Microbiologist

Jan 2007 – Nov 2007 · 10 mos · India · On-site

  • Water analysis, TAMC, TYMC

Ataide crown closure and bottling company pvt ltd

Chemist

Jan 2006 – Dec 2006 · 11 mos · India · On-site

  • Water analysis

Education

Kuvempu University

Master of Science - MS — Microbiology and biotechnology

Jan 2012 – Jan 2014

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