
Operations Manager
5 days ago
Role Overview:
The Assistant Manager will be responsible for ensuring compliance with cGMP regulations at site. They will work closely with the Quality Assurance (QA) representative to manage vendors and ensure their qualification and re-qualification status is up-to-date.
Key Responsibilities:
- To review vendor documents for qualification and ensure they meet all necessary requirements.
- To conduct audits of vendors to verify compliance with company policies and regulations.
- To prepare and submit audit reports, confirming vendor compliance.
- To review and approve lists of approved vendors.
- To coordinate with the purchasing team to receive pre-purchase samples and send them to Quality Control/Assurance and Regulatory Documents (QC/ARD) for assessment.
- To review analyzed reports and take necessary actions as applicable.
- To participate in investigations related to vendor issues.
- To follow up with vendors regarding Corrective Action Preventative Actions (CAPA).
Requirements:
- cGMP knowledge and experience.
- Vendor management skills.
- Auditing and inspection expertise.
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