Sr. Quality Assurance Specialist
SiegfriedAbout the role
"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.
Your Role:
The incumbent assures compliance to all regulatory requirements, current Good Manufacturing Practices, and company Policies, Standard Operating Procedures and Work Instructions.Your Profile:
ESSENTIAL DUTIES, RESPONSIBILITIES AND ACCOUNTABILITIES:
Reviews, approve and tracks executed production records.
Reviews and approves production and QC investigations.
Reviews lab sample results and manufacturing records related to qualification/validation activities.
Conducts, write, and reviews quality related investigations as appropriate.
Reviews and approves Master Production Records.
Responsible for cGMP compliance of assigned manufacturing operations / areas.
Completes QMS items as assigned.
Is responsible for the conditional / final release of materials.
Hosts customer and internal audits, as needed
Conduct internal and external audits, as needed
Participates in inspections by regulatory authorities
Writes and reviews Annual Product Reviews/Product Quality Reviews
Writes and reviews Product Validation / Qualification / Assessments documents.
Writes and reviews Equipment Qualifications / Assessments documents.
Writes and reviews Computerized Systems Validations / Assessments documents.
Reviews, evaluates and approves minor equipment changes.
Conducts GMP inspections.
Conducts environmental monitoring.
Reviews and approves CMC sections of DMFs as appropriate.
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