Mobarshir Junaid Shaikh

Analytical QA/QC Specialist

Analytical QA/QC Specialist with over 10 years of experience in GMP-regulated pharmaceutical environments across the entire value chain. Proven expertise in OOS/OOT investigations, audit trail review, stability studies, and sample management. Experienced in EU-GMP, USFDA, and MHRA compliance, leading international inspections, and data integrity according to ALCOA+.

Frankfurt am Main, Deutschland

Languages

Skills

Certifications

Work Experience

Executive Analytical QA

Sovereign Pharma Pvt. Ltd., Indien

Sep 2023 — Sep 2025

Served as single point of contact for EU, MHRA, USFDA, and other regulatory inspections representing quality department
Planned, coordinated, and led regulatory inspections with 100% complete and inspection-ready documentation
Initiated and established four-year OOS/OOT trend analysis programs to reduce risks early; trained 25+ staff in data integrity and deviation management
Conducted and documented method executions, chromatographic controls (Empower, Chromeleon) and audit trails per ALCOA+
Managed creation, review, and approval of SOPs, deviation reports, CAPAs, and change controls in TrackWise system
Performed internal QC audits with 95% deviation closure rate within 30 days
Planned and accompanied 20+ supplier and contract lab audits including detailed reports and corrective action follow-up
Achieved 15% sustainable efficiency improvement through targeted SOP optimization and process streamlining

Executive Analytical QA

Exemed Pharmaceuticals, Indien

Aug 2021 — Sep 2023

Led Analytical QA team of 65+ QC analysts ensuring compliance with EU-GMP and international quality standards
Reviewed and approved batch protocols, Certificates of Analysis (CoAs), deviations, CAPAs, and change controls in electronic QMS
Reduced batch release time by 15% through process optimization and closer QC-QA coordination
Planned, documented, and supported equipment qualifications and GMP supplier evaluation and monitoring

Senior Officer – Quality Control

Umedica Laboratories Ltd., Indien

Aug 2020 — Aug 2021

Performed systematic audit trail reviews for HPLC, GC, UPLC, UV, and stability chamber systems to ensure data integrity and traceability
Managed data review for raw materials, packaging, finished products, and ongoing stability studies per GMP and ALCOA+ requirements

Senior Chemist

Mylan Laboratories Limited, Indien

Sep 2017 — Aug 2020

Conducted routine and out-of-specification analyses for raw materials, intermediates, and finished products per validated test methods
Supported preparation and execution of regulatory and customer audits; prepared and reviewed analytical reports and test protocols
Contributed to batch release documentation and maintenance of reference and reserve samples

Junior Officer – Quality Control

IPCA Laboratories Limited, Indien

Apr 2015 — Sep 2017

Tested raw materials, packaging materials, stability, and finished product samples per GLP and pharmacopoeia standards
Managed reference standards and reserve samples (Control/Reserve Sample Management) and performed follow-up analyses

Skills

Regulatory Compliance: EU-GMP, USFDA, MHRA, WHO cGMP, ICH Q7, ICH Q10, ALCOA+, Inspektionsbereitschaft, DatenintegritätAnalytical QA/QC: OOS, OOT, Methodenvalidierung, Methodenverifizierung, Methodentransfer, Stabilitätsstudien, Audit-Trail-Review, Chargenfreigabe, CAPA, Änderungsontrolle, Abweichungsmanagement, Chargenprotokollprüfung, SOP-Lifecycle, Referenz- und Rückstellmustermanagement (Control/Reserve Sample Management)Instrumente: HPLC, UPLC, LC/MS, UV/Vis, Dissolution, FTIR, TOC, Karl-Fischer, GC, pH-MeterSoftware & Systeme: TrackWise, LIMS, QMS, DMS, Empower, Chromeleon, LabSolutions, SAP, Minitab, JMP, 21 CFR Part 11

Education

Bachelor of Pharmacy

Savitribai Phule Pune University, Indien

Certifications

ISO 9001:2015 – QMS Auditor

Certified Quality Auditor (CQA)

21 CFR Part 11 Compliance

Languages

English

Fluent

Hindi

Native

German

Intermediate