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Lisa is the VP of Quality in a pharmaceutical company. She oversees all facets of the company’s Quality Control (QC) and Quality Assurance (QA) to ensure that the product is manufactured in adherence to the customer-set quality standards and regulatory requirements. She has a hectic day managing suppliers, customers and collaborating with the internal teams on overall quality management.
She is in a very demanding role that has a direct impact on organizational objectives and overall company performance. Upkeep of quality ensures lower product costs, minimal wastage and higher profit margins. She handles most volatile situations with a calm demeanor and continues to do her job in ensuring high quality standards.
01
RESPONSIBILITIES
- Spearheading Quality for pharmaceutical products.
- Provide a strategic direction for quality assurance, quality control and compliance activities for pharmaceutical products.
- Drive continuous improvement programs through internal operations including setting up processes for third party manufacturers.
- Supplier management including quality and compliance, audit, quality agreements and Relationship management.
- Overlooking Quality aspects of Product Commercialization.
- Global quality system design, compliance and implementation.
02
OBJECTIVES
- Increase Product Reputation by improving Product Quality standards.
- Protect brand reputation by assessing Product feedback and Performance.
- Manage Batches Quality and maintain inventory with electronic signatures.
- Simplify Inventory Batch traceability and strengthen compliance reporting to simplify FDA audits.
- Track compliance for Product storage, manufacturing and Quality to avoid unnecessary risks with FDA.
03
PAIN POINTS
- Inability to do an instant electronic batch trace.
- Issues identifying paperwork attested with the right approvers.
- Cumbersome reporting making FDA audits challenging.
- Inability to identify patterns that fix processes proactively for the future.
04
THE RIGHT SYSTEM
- cGMP Compliant.
- CFR 21 Part 11 Compliant.
- Lot Inheritance and Batch traceability.
- Electronic Signatures on key transactions.
- Audit reporting.
- Compliance reporting.
- Quality Control and Quality Assurance records.
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