Quality Assurance Specialist

Job Description

We are seeking a highly organized and detail-oriented Quality Assurance Specialist to work collaboratively with stakeholders to implement and maintain quality management systems.

Key Responsibilities:

• Establishes and maintains local quality management systems to meet regulatory and industry standards.
• Supports maintenance of relevant licenses and ensures compliance with local requirements.
• Manages local processes for change control, deviation, CAPA, complaint management, and supplier management.
• Manages local Quality Management Review process and Risk Assessment/Management for any quality-related risks.
• Participates in the company's Quality Escalation process for critical quality issues and regulatory compliance issues.
• Ensures up-to-date organograms, training curricula pertaining to GMP/GDP, training records, CVs, and Job Descriptions are in place for personnel working on quality matters.
• Establishes and maintains the Affiliate Quality Manual and GMP/GDP procedural documents.
• Establishes and maintains the Quality Agreement with suppliers/service providers.
• Reviews Annual Product Quality Reports (if applicable).
• Ensures shipping conditions match product license/product label particulars and transporters are appropriately qualified.
• Ensures premises and/or equipment used are reviewed regularly to ensure they are adequate for handling, storage, and distribution of medicinal products.
• Supports Customer Services with enquiries of a GDP nature such as delivery issues, transportation conditions, disputes, etc.
• Provides guidance on supply-related issues and arranges authorized relabeling/repackaging as needed.
• Supports the management of quality and distribution complaints and supports the investigation of fraudulent and counterfeit medicinal products.
• Manages product return and destruction and manages local recalls.
• Qualifies and manages local 3PL/4PL and supports audit of 3PL/4PL.
• Qualifies and manages local GMP/GDP related suppliers/service providers, auditing and approving these according to local requirements.
• Assures customers validations and adequate records compliance to QA requirements are established and maintained for all distributors/customers.
• Hosts and leads Health Authority inspections and corporate audits.
• Manages the self-inspection program and supports audit of distributor (where applicable).
• Collaborates with Regulatory Affairs to implement activities for new product launch and product life cycle management.

Benefits

• Opportunity to work in a collaborative environment.
• Chance to develop skills in quality assurance and management.
• Possibility to contribute to the company's success.

Requirements

• Degree in a relevant field.
• Proven experience in quality assurance and management.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.