SHAHID HUSSAIN

Company Overview: GSK is a global pharmaceutical and biotechnology company that engages in the research and clinical phases of vaccine development and general drug products

• Approval of suppliers, incoming materials, and service providers
• Managed supplier interaction, material qualification, and root cause analysis for vendor material management programs (Biologic's/Vaccine)
• Conducted material qualifications by reading specifications, engaging suppliers, and ensuring compliance with regulatory requirements
• Reviewed technical documentation for accuracy and completeness and dispositions for all incoming raw materials supplies, including the Material Documentation File (MDF), and completed the QA disposition checklist
• Planned, sourced, labeled, and packaged materials, working closely with manufacturing operations and QC.
• Performed identification and assessment of new vendors, quality agreement revisions, and the Approved Supplier List (ASL) maintenance
• Participated in internal and external supplier audits, ensuring supplier validations met quality standards
• Led CAPA processes, including discrepancy reporting, deviations, and corrective/preventive actions for nonconforming materials or services
• Reviewed and resolved supplier change notifications (SCN) and monitored SCAR/incident actions
• Supported line operations and provided supplier validation oversight, ensuring compliance with organizational and regulatory standard.
• Conducted regular audits to ensure adherence to industry standards and internal policies, maintaining a high level of compliance throughout the organization.
• Established strong working relationships with development teams, fostering a collaborative environment that facilitated rapid identification and resolution of quality issues.

• Performed internal and external supplier audits, including scheduling, preparation, and follow-ups
• Conducted risk assessments for discrepancies, deviations, and non-conformance material reports (NCMR)
• Collaborated with cross-functional teams to evaluate suppliers, qualify materials, and ensure compliance with specifications and regulatory requirements
• Managed supplier interaction to evaluate material consistency, specifications, and process validation
• Executed CAPA processes to address quality concerns in material handling and supplier performance
• Reviewed material qualifications, dock receipt reports, and onboarding documentation accuracy & compliance.
• Assisted in root cause analysis investigations, leading to more efficient problem-solving techniques within the team.
• Inspected items and compared against standards to meet regulatory requirements.
• Inspected raw materials and finished products to verify quality and disposed items that did not meet safety requirements.

• Conducted internal and external GMP audits, supporting compliance with quality systems and regulatory standards
• Reviewed and approved supplier validations, material specifications, and CAPA-related documentation
• Performed risk assessments for material qualification and supplier-related discrepancies
• Supported implementation of electronic quality systems and generated metrics for management review
• Facilitated supplier interaction to address quality issues and improve material qualification processes
• Evaluated accuracy of existing quality assurance measurement techniques, implementing improvements to increase efficacy and reduce errors.

• Released lots of APIs, intermediates, and drug products by reviewing records and conducting material qualifications
• Managed supplier interactions, material risk assessments, and validation processes
• Reviewed specifications and engaged with suppliers to resolve quality issues through CAPA processes
• Disposed of materials and approved changes through validation and change control
• Conducted investigations, including root cause analysis, for supplier-related non-conformances
• Ensured compliance with regulatory requirements by performing regular audits and staying up-to-date on industry standards.
• Performed observations and evaluated supporting documents to supplement audit findings.

• Conducted GMP audits to ensure compliance with US FDA regulations, ISO standards, and MDR/IVDR requirements
• Reviewed material specifications, conducted supplier process validation, and ensured adherence to quality
• Performed risk assessments for material qualifications and evaluated supply chain compliance
• Collaborated with suppliers to ensure process validation and material consistency
• Supported CAPA processes, line support, and supplier validation activities
• Prepared working papers, reports, and supporting documentation for audit findings.