MUBASHAR MOHAMMED
Hyderabad
Summary
Result-oriented Quality Control Assistant Manager with over 18 years of comprehensive experience in the pharmaceutical industry across India and the UAE. Demonstrated expertise in managing end-to-end analytical laboratory operations, Computerized System Validations (CSV), 21 CFR Part 11 compliance, and data integrity governance. Proven track record in conducting complex OOS/OOT investigations, Deviations, CAPA , Method transfers, Instrument qualifications, and leading cross-functional teams through successful USFDA, MHRA, EU GMP, TGA, ANVISA ,WHO and global regulatory audits.
Overview
19
19
years of professional experience
1
1
Language
Work History
Assistant Manager – Quality Control
MSN Labs Pvt Ltd
Hyderabad
2019.06 - Current
- Daily QC Laboratory Operations & Commercial Batch Release
- End-to-End QC Operations Leadership: Directed and supervised daily Quality Control laboratory workflows, resource allocation, and sample scheduling for raw materials, in-process controls (IPC), finished products, and stability samples across commercial product lines in strict adherence to cGMP, ICH, and pharmacopeial (USP, EP, BP, IP) standards and led a team of 80 analysts.
- Analytical Data Review & Batch Disposition: Performed rigorous technical and compliance reviews of analytical raw data, chromatograms, calculations, and Certificates of Analysis (CoAs) to ensure zero-defect documentation prior to commercial batch release, significantly reducing batch turnaround times (TAT) while maintaining 100% regulatory compliance.
- Ensured compliance with data integrity regulations by implementing 21 CFR Part 11 standards across laboratory systems.
- Enterprise Data Integrity Enforcement: Championed and enforced ALCOA+ principles and 21 CFR Part 11 / EU GMP Annex 11 data integrity compliance across all standalone and networked laboratory systems, including Chromatographic Data Systems (Empower 3, LabSolutions) and Non-Chromatographic Systems (UV-Vis, FTIR, Karl Fischer, Dissolution, pH/Conductivity meters, and Analytical Balances).
- System Security & Access Control Administration: Managed laboratory Role-Based Access Control (RBAC) matrices—overseeing user onboarding, privilege modification, periodic access reviews, and immediate revocation—ensuring strict segregation of duties (preventing analysts from accessing administrative privileges such as system clock changes, file deletion, or audit trail disabling).
- Laboratory Investigations (OOS, OOT, OOC), CAPA & Regulatory Responses
- Spearheaded laboratory investigations for Out-of-Specification (OOS), Out-of-Trend (OOT), Out-of-Calibration (OOC), and invalid test results, employing structured Root Cause Analysis (RCA) tools to identify laboratory and process-related issues in accordance with regulatory guidance.
- Investigated customer market complaints and developed corrective actions to enhance product quality.: Investigated product quality market complaints, authored comprehensive investigation reports, and designed risk-mitigating Corrective and Preventive Actions (CAPA), tracking implementation milestones and conducting formal Effectiveness Checks to prevent recurrence. Drafted scientifically sound, data-backed responses to regulatory deficiency letters and inspection observations.
- Regulatory Inspection Readiness & Audit Hosting
- Frontline Regulatory Audit Host: Acted as the primary technical subject matter expert (SME) and audit host for QC laboratory operations during high-stakes global regulatory inspections (US FDA, MHRA, TGA), Corporate Quality Assurance (CQA) audits, and customer audits.
- Managed laboratory walk-throughs and presented analytical investigations to inspectors, ensuring effective defence of chromatographic audit trails and data integrity controls while facilitating seamless document retrieval during audits.
- Enterprise Quality Digitalization & Software Implementation
- Led end-to-end implementation and user acceptance testing (UAT) of enterprise quality digitalisation platforms, including Laboratory Information Management Systems (LIMS), Electronic Document Management Systems (eDMS), and Learn IQ Learning Management Systems (LMS), enhancing operational efficiency and compliance.
- Paperless Workflow Optimization: Transitioned manual paper-based laboratory logs, sample tracking, specification management, and training records into validated electronic workflows, enhancing traceability, eliminating transcription errors, and streamlining audit readiness.
- Analyst Qualification, Mentorship & Training Governance
- Competency & Analyst Qualification Program: Designed and executed structured onboarding, On-the-Job Training (OJT), and practical analyst qualification protocols for newly hired analytical chemists across wet chemistry and sophisticated instrumental techniques (HPLC, UPLC, GC, Dissolution, UV-Vis).
- Continuous Upskilling & Periodic Requalification: Conducted regular cGLP, data integrity, and SOP refresher training sessions to foster a culture of quality ownership, while managing the annual/periodic requalification matrix to verify sustained technical proficiency across the QC team.
- Cross-Functional Internal Auditing
- CGMP Self-Inspection & Cross-Departmental Auditing: Participated as a qualified internal auditor to inspect cross-functional departments—including Manufacturing, Warehouse/Dispensing, Engineering, Microbiology, and Quality Assurance—against internal SOPs and current regulatory expectations.
- Compliance Gap Identification: Evaluated facility housekeeping, logbook completeness, calibration statuses, and shop-floor cGMP adherence, issuing constructive audit observations and verifying timely CAPA closures prior to external regulatory visits.
- Scheduled Data Lifecycle Governance: Executed and verified periodic data backups, secure archival, and controlled project deletion/purging across chromatographic and non-chromatographic workstations in strict compliance with site data retention policies and 21 CFR Part 11 requirements.
- Data Restoration & Integrity Verification: Performed periodic mock data restoration drills from backup servers/media to verify file readability, metadata preservation, and audit trail completeness, ensuring 100% data recoverability in the event of hardware failure or disaster recovery scenarios.
- Controlled Project & Method Lifecycle Setup: Governed the creation, naming convention standardization, and locking of electronic projects, sample sets.
Senior Executive – Quality Control
Wockhardt Bio AG
Dubai
2018.05 - 2019.04
- Contributed to establishment of new QC laboratory by developing standard operating procedures (SOP) and specifications.
- Qualified laboratory instruments and equipment for quality control, ensuring compliance with regulatory standards.
- End-to-End Lifecycle Execution: Authored, reviewed, and executed User Requirement Specifications (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols in compliance with USP <1058> (Analytical Instrument Qualification), EU GMP Annex 15, and USFDA guidelines.
- Chromatography & Spectroscopy Systems: Executed qualification and periodic requalification for High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), Gas Chromatography (GC) with Headspace, UV-Visible Spectrophotometers, Fourier-Transform Infrared Spectrophotometers (FTIR).
- Physical & Wet Chemistry Instruments: Qualified Karl Fischer (KF) Titrators (Coulometric & Volumetric), Auto-Titrators (Potentiometric), Dissolution Apparatus (USP Type I, II), Disintegration Testers, Friability Testers, Hardness Testers, Tap Density Testers, Analytical & Micro Balances, pH Meters, Conductivity Meters, Polarimeters.
- Collaborated in cross-functional technology transfer programs to validate new analytical testing methods for commercial drug formulations, enhancing testing reliability.
- Conducted computerised system validation and ensured data integrity through rigorous testing protocols.
- Regulatory Compliance: Executed risk-based CSV lifecycle deliverables aligned with GAMP 5 (Second Edition), 21 CFR Part 11, and EU GMP Annex 11, ensuring strict adherence to ALCOA+ data integrity principles.
- Enterprise & Standalone Software Validated: Validated Chromatography Data Systems (CDS) such as Empower 3, Laboratory Information Management Systems (LIMS); Document Management Systems (DMS); and standalone instrument firmware/software (e.g., LabSolutions, Tiamo, Rudolph.)
- Validation Deliverables & Security Controls: Prepared Validation Master Plans (VMP), Risk Assessments (FMEA), Traceability Matrices (RTM), System Security & Audit Trail Review SOPs, User Access Control matrices, and Backup/Disaster Recovery verification protocols.
- Pharmaceutical Water System Validation
- Multi-Phase Water Validation: Executed Phase 1 (Investigation/Baseline), Phase 2 (Control/Monitoring), and Phase 3 (Long-Term Surveillance) validation protocols for Purified Water (PW), Water for Injection (WFI), for storage, and distribution loops.
- Oversaw calibration and preventive maintenance programmes for laboratory instruments, ensuring consistent accuracy and compliance with quality standards.
- Out-of-Calibration (OOC) Handling: Managed calibration deviations, initiated Out-of-Calibration (OOC) impact assessments on previously tested batches, and executed Root Cause Analysis (RCA) and CAPA.
Quality Control Specialist
Global Pharma – A Sanofi Company
Dubai
2012.07 - 2018.05
- Executed comprehensive testing and data verification for raw materials, water samples, in-process controls, and finished products (including Penicillin and General Products).
- Performed routine qualification, calibration, and preventive maintenance coordination for high-precision analytical equipment including UPLC, HPLC, GC,UV Visible spectrophotometers , Disintegration testing Apparatus, Hardness Tester, Polarimeter,FTIR, Bulk Density Apparatus,Dissolution Apparatus, Karl Fischer Apparatus, Autotitrator, pH and Conductivity meters ,Sieve shaker, Ovens, Muffle Furnace and TOC instruments.
- Carried out method validations and Method transfers of finished products.
- Prepared stability protocols, stability master schedules , Stability Monthly schedules, monitored sample pull-outs, Incubation of stability samples, Updated stability data sheets, Maintenance of stability walk-in chambers and compiled comparative market product analytical profiles (Disso profiling).
- Collaborated with site QA and regulatory teams to secure artwork approvals in strict alignment with regulatory filings, ensuring compliance and quality standards.
Analyst – Quality Control
Cipla Ltd
Goa
2010.03 - 2012.07
- Conducted chemical and physical analysis of raw materials and finished dosage forms using HPLC, GC, UV-Vis, and dissolution apparatus to ensure compliance with quality standards.
- Carried out analysis of tests like Related substances, Enantiomeric Purity,Assay, Content Uniformity, Blend Uniformity, Dissolution Profiling, Hardness, Disintegration, Water Content by KFR, Loss on drying and Residue on ignition.
- Conducted incubation of samples in stability chambers,Updating of stability data sheets, Hold time study samples.
Analyst – Quality Control
Reliance Cellulose Pvt Ltd
Hyderabad
2007.07 - 2010.02
- Performed detailed laboratory analysis on samples, assessing characteristics such as solubility, water content, loss on drying, residue on ignition, pH, conductivity, melting range, assay by titrimetry and potentiometry, specific optical rotation, identification by FTIR, and weight per ml to support product quality assurance.
- Conducted routine laboratory testing of incoming raw materials, in-process samples, intermediates, and finished products to ensure quality compliance.
- Operated laboratory instruments including Karl Fischer apparatus, FTIR, UV-visible spectrophotometer, autotitrator, TLC photo documentation system, bulk density apparatus, sieve shaker, halogen moisture analyser, and particle size analyser for accurate analytical results.
Education
Master of Science (M.Sc.) - Organic Chemistry
Osmania University
Hyderabad, TG2007-01
Bachelor of Science (B.Sc.) - Mathematics, Physics & Chemistry
Osmania University
Hyderabad, TG2005-01
Skills
- Regulatory compliance audits
- Laboratory quality systems
- Analytical instrumentation expertise
- Quality control
- Regulatory compliance
- Analytical testing
- Data Integrity & Software: Enterprise CDS (Empower), User Access Management, Learn IQ, MS Office Suite
- Budget and vendor management
LANGUAGES
English, Urdu, Telugu, Hindi.
Timeline
Assistant Manager – Quality Control
MSN Labs Pvt Ltd
2019.06 - Current
Senior Executive – Quality Control
Wockhardt Bio AG
2018.05 - 2019.04
Quality Control Specialist
Global Pharma – A Sanofi Company
2012.07 - 2018.05
Analyst – Quality Control
Cipla Ltd
2010.03 - 2012.07
Analyst – Quality Control
Reliance Cellulose Pvt Ltd
2007.07 - 2010.02
Master of Science (M.Sc.) - Organic Chemistry
Osmania University
Bachelor of Science (B.Sc.) - Mathematics, Physics & Chemistry
Osmania University