Open to opportunities

Sadia Shaukat

@sadiashaukat

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Senior Quality Assurance leader delivering QMS/eQMS transformation with zero critical observations.

Pakistan

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What I'm looking for

I’m seeking a remote QA role where broad regulatory expertise and proven digital quality leadership make lasting impact across pharma, nutraceutical, or medical device environments—built around QMS/eQMS ownership, strong audit readiness, and remote-first execution.

I’m a Senior Quality Assurance professional with 8+ years of progressive, hands-on ownership across pharmaceutical and nutraceutical manufacturing, owning the full QA spectrum—from QMS design and eQMS implementation to CAPA management, document control, stability studies, and regulatory audit management. I delivered zero critical observations across PIC/S and FDA inspections, and I’m known for strong regulatory writing (SOPs, CAPA reports, and audit responses) optimized for remote review.

I’ve led digital transformation initiatives including paperless QMS migration and artwork digitalization (migrating 50+ SOPs to Qualio and 200+ artworks into QMS), combining compliance rigor with practical operational execution. Currently, I consult remotely and’m actively expanding into ISO 13485 medical device quality systems and Veeva Vault, seeking a remote QA role where my broad regulatory expertise and proven digital quality leadership can create lasting impact.

Experience

Work history, roles, and key accomplishments

Current

Quality Assurance Consultant

Current

Self-Employed

Nov 2025 - Present (5 months)

Delivered remote QMS gap assessments and audit-ready documentation (CAPAs, SOPs, risk assessments) for pharma and nutraceutical clients, advising on cloud eQMS selection and onboarding. Supported digital quality transformations (paperless QMS and artwork digitalization) with zero critical observations across PIC/S and FDA inspections.

CAPA Management Document Control FDA

Assistant Manager, QA

Remington Pharma Pvt. Ltd.

May 2025 - Oct 2025 (5 months)

Core team member for Qualio eQMS establishment, leading transition from paper-based to fully paperless QMS and migrating 50+ SOPs. Owned site-wide document control, CAPA, and change control, and prepared audit-ready packages supporting PIC/S and FDA inspections with zero critical observations.

Qualio EQMS Document Control CAPA Management Change Control Validation (21 CFR Part 11)WHO GMP ISHIKAWA Audit Support

Assistant Manager, QA

Wilshire Labs Pvt. Ltd.

Mar 2018 - May 2025 (7 years 2 months)

Served as site quality gate-keeper with delegated authority for BMR/BPR and final approval of BMRs, master formulations, packaging artworks, and BOMs in Oracle ERP. Owned digital artwork management, migrating 200+ approved artworks and reducing retrieval/approval time by 30%, while leading CAPA, QRM (ICH Q9), thermal mapping, stability studies, and 10+ regulatory audits with zero critical observat

Oracle ERP BMR BPR Review & Approval CAPA Management Site Master File & Quality Manual PIC S & FDA Audits Document Control

Quality Assurance Officer

Medipak Pharma Pvt. Ltd.

Jul 2017 - Feb 2018 (7 months)

Performed in-process quality checks and environmental monitoring in sterile/control manufacturing areas and reviewed BMRs and BPRs for batch release accuracy. Supported documentation compliance and quality oversight for sterile manufacturing operations.

Sterile Manufacturing QA Environmental Monitoring BPR Review