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Pharmaceutical Quality Assurance Specialist
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This position involves leading and managing QA operational tasks in the Pharmaceutical Quality System (PQS), ensuring compliance with regulations and industry standards.
- As a key member of the quality team, this role is responsible for developing and implementing quality assurance strategies.
- Serves as a Subject Matter Expert (SME) for key PQS systems, including deviations, change control, complaints, validation, quality risk management, and GxP processes.
- This role requires reviewing and approving Standard Operating Procedures and other controlled documents in the PQS.
- A management role with direct QA Specialist reports, focusing on delivering a high-performance quality culture and staff development.
- Develops and owns quality metrics for the organization, driving data-driven decision making.
This role involves collaborating with internal stakeholders to ensure compliance with regulations and industry standards.
- Reviews and advises on master batch documentation development and reviews batch documentation.
- Collaborates with suppliers to ensure quality assurance and compliance.
- Monitors operational activities at approved service providers.
- Prepares and reviews Quality Agreements.
To be successful in this role, applicants should possess:
- At least 5 years' experience in cGMP pharmaceutical operations with direct experience in quality systems.
- A primary degree in a scientific discipline or equivalent.
- Ability to work independently and influence a high-performance quality culture.
- Strong decision-making skills in nuanced frameworks.
