Company
Our client operates within the pharmaceutical and chemical industries, or collaborates with government drug-regulatory agencies. They are committed to maintaining the highest standards of quality and compliance across their operations.
Job Description
We are seeking a Senior Quality Assurance Auditor to join our client’s team. This role involves performing audits and inspections to ensure adherence to GMP, SOPs, and global regulatory standards, supporting the company’s commitment to quality and compliance.
Responsibilities
- Conduct routine audits of data, procedures, equipment, systems (including computer systems), and facilities to verify compliance with SOPs, GMPs, and international regulations.
- Review and approve production and analytical documentation related to the release of active pharmaceutical ingredients (API), safety assessments, or clinical supply lots (both bulk and packaged), ensuring they meet regulatory standards.
- Communicate audit findings and collaborate with relevant departments to address and resolve any issues identified.
- Perform audits or inspections of assigned areas or systems, either independently or as part of a team, to assess regulatory and company compliance.
- Prepare and present reports summarizing deficiencies and work with teams to implement corrective actions.
- Notify management of inspection results, providing guidance on necessary follow-up actions.
- Support deviation and change management processes, as well as validation and qualification activities, demonstrating expert knowledge in these areas.
Requirements
- Proven experience in the pharmaceutical or chemical industry, or within a government drug-regulatory agency.
- Strong knowledge of cGMP regulations.
- Excellent oral and written communication skills.
- Experience in deviation management, change control, validation, and qualification systems.
Other Information
If you are interested and want to apply, please submit your application via the apply button below and contact me.
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Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
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