Amber T.
Senior Pharmaceutical Quality Assurance Manager
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Dr. Amber T. is a seasoned Senior Quality Assurance Leader with over 15 years of experience in the pharmaceutical industry. She has held key roles at ATCO Laboratories and GlaxoSmithKline, where she led diverse teams and drove strategic initiatives to maintain robust quality management systems. Amber's expertise in Regulatory Compliance across PIC/S, WHO, EU-GMP, and FDA frameworks is complemented by her skills in supplier qualification, process validation, and change control. As a Certified Lead Auditor for ISO 9001:2015 and an SAP QM specialist, she has enhanced quality assurance protocols, managed cross-functional collaborations, and delivered comprehensive training programs. Amber's leadership has been pivotal in securing international quality certifications and implementing risk-based quality decision-making processes that ensure consistent product quality and regulatory compliance. Her educational background includes a Doctor of Pharmacy and an ongoing MBA, underpinning her technical and strategic capabilities.
Experience
Senior Manager – Quality Assurance
ATCO Laboratories Limited · 2024 — PresentActed as a key auditee during PIC/S inspections, influencing favorable certification results. Led supplier qualification and re-qualification initiatives for APIs, excipients, packaging materials, and service providers across various quality frameworks. Conducted risk-based assessments and ongoing performance monitoring of suppliers. Ensured compliance with appropriate standards, managing self-inspection programs and maintaining readiness for regulatory audits. Reviewed supplier validation documents including process and cleaning validation. Supervised the qualification of equipment, utilities, and computerized systems while managing artwork development and corrective actions.Manager – Quality Assurance
ATCO Laboratories Limited · 2020 — 2024Oversaw product release along with change control and CAPA documentation across manufacturing lines. Produced monthly Quality KPI reports and trend analyses related to deviations and process performance. Led both internal and external audits and coordinated GMP training for various departments. Reviewed and ensured compliance of artwork approvals for regulatory purposes.Assistant Manager – Quality Assurance
GlaxoSmithKline (GSK) · 2017 — 2020Managed the implementation of the SAP QM system as a SME, focusing on master data integrity and GO-LIVE procedures. Coordinated change control processes and supervised deviation management along with root cause investigations. Administered Pack Lab operations and led internal audits and artwork management workflows.Executive – Regulatory Affairs & Pharmacovigilance
Herbion Pharma · 2017 — 2017Compiled stability data, conducted chemical testing, and prepared regulatory submission documentation. Executed pharmacovigilance activities in accordance with regulatory standards and updated SOPs to uphold compliance.Officer – Quality Assurance
Martin Dow Pharmaceuticals · 2016 — 2017Ensured prompt batch release while conducting Annual Product Quality Reviews. Managed deviation investigations and risk assessments, as well as Bill of Materials controls.
Skills & Expertise
Education
- Doctor of Pharmacy (Pharm-D)Federal Urdu University · 2006 — 2010
- MBA (In Progress)Institute of Business Management (IoBM)