Quality Assurance Specialist
2 weeks ago
About PharmEng Technology
Job Summary: The Quality Assurance Consultant is responsible for the implementation, maintenance, and oversight of the Quality Management System (QMS) in local affiliates. This role ensures compliance with regulatory requirements, quality standards, and company policies. The Quality Assurance Consultant will manage quality risk, complaints, change controls, deviations, CAPA, authority inspections, self-inspections, GxP surveillance, product quality reviews, training, local product release, and oversight of GDP requirements for local warehousing and distribution.
Key Responsibilities
- Maintaining a robust Quality Management System (QMS) across local affiliates.
- Ensuring adherence to regulatory requirements and quality standards.
- Developing and implementing effective quality risk management strategies.
- Managing complaint resolution processes and maintaining a local complaint coordinator role.
- Collaborating with cross-functional teams to implement change control procedures.
- Leading deviation management and investigation processes.
- Maintaining and reviewing CAPA plans.
- Scheduling and conducting authority inspections and self-inspections.
- Conducting regular GxP surveillance and assessments.
- Coordinating product quality reviews (PQR).
- Developing and delivering training programs to local staff.
- Oversight of GDP requirements for local warehousing and distribution.
- Evaluating shipping lane qualifications and secondary distribution transport performance.
- Reviewing return management processes, including QA evaluation against return criteria.
- Assessing product recall management, including local recall execution and communication with customers.
- Monitoring GxP suppliers and their compliance status.
- Ensuring local repackaging and relabeling procedures meet quality standards.
Qualifications
- Bachelor's degree in Quality Management, Life Sciences, or a related field.
- Minimum of 5 years of experience in Quality Assurance within the pharmaceutical or healthcare industry.
- Strong knowledge of GxP regulations and quality standards.
- Excellent analytical, problem-solving, and communication skills.
- Ability to work independently and collaboratively in a team environment.
- Proficiency in using Quality Management Systems and Learning Management Systems (LMS).
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