Quality Assurance Specialist
1 week ago
A mission-driven organization focuses on prioritizing patients. Our daily objective is to provide life-saving products that would otherwise be inaccessible.
We believe that access to these life-saving drugs is a fundamental human right. In essence, our goal is to put patients first through innovation.
Over three decades, we have developed a proprietary process enabling countries to transform collected plasma into life-saving products.
An exciting opportunity has arisen for a Quality Control Manager to join the team. Reporting to the Chief RAQA, you will oversee reviewing and approving specifications, testing data, and other factors affecting the quality of the finished product to ensure no errors occur along with the final product itself.
In this role, you will lead the Quality Control team, ensuring compliance with Good Laboratory Practice (GLP) and maintaining the highest standard of quality as we qualify our equipment in newly built laboratories.
The position requires managing and leading a growing team.
Key Responsibilities:
- Perform full spectrum of QC functions.
- Set-up and maintain QC laboratory.
- Ensure QC and operational compliance with regulatory requirements.
- Lead key QC systems such as testing, release of raw materials and finished products, etc.
- Support Quality Assurance & Regulatory activities.
- Lead in developing and implementing quality strategies and key reporting metrics.
- Evaluates production capabilities and recommend improvements.
- Deviation and compliant management, Products and Materials Release, Validation and Change Control Support, New product introduction and Documentation Control to ensure an efficient operational QC system that assures full compliance with company policies, regulatory requirement and cGMP.
- Responsible for ensuring that product to be released meets specification and regulatory requirements.
- Responsible for providing quality control oversight for Operations activities.
- Raise Out-of-Specification (OOS) and lead the investigations.
- Ensure the effectiveness of investigations and to make decisions on the adequacy of investigations, root cause analysis and corrective and preventive actions.
- Ensure inspection readiness of the area with respect to all internal and external audits. When required provide responses and timely follow up on relevant corrective actions and commitments made as a result of the inspections, communicating with regulatory agencies as necessary.
- Establishing appropriate controls for the QC Laboratory.
- Provide support/guidance for the implementation and maintenance of corporate and cGMP standards.
- Perform all duties necessary to confirm compliance with local regulatory and company requirements.
Requirements:
- Ability to work on several projects simultaneously.
About Us:
We offer a dynamic environment where individuals can grow alongside the organization, providing bandwidth to explore innovative solutions while keeping patients at the centre of everything we do. We collaborate with global industry experts in an organization where you can thrive.
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