Job Description:
Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses.
Our divisions operate in a complex global regulatory environment, ensuring that vital medicines are delivered securely on time and wherever they are needed in the world.
Key Responsibilities:
* Follow, promote, and enforce relevant SOPs, Job Aids, and Company policies and procedures.
* Assist in maintaining the appropriate standards of GMP and GDP.
* Originate, review, approve, maintain, and archive quality documentation, including Policies, SOPs, etc.
* Assist in delivering training in this area.
* Coordinate Quality Assurance raw data to ensure compliance with regulatory expectations.
* Collate raw data to support monthly Quality Management System (QMS) reporting.
* Contribute to the delivery of QA projects as required.
* Deal with QA enquiries promptly and with due diligence.
* Ensure all quality-critical documents are appropriately maintained, reviewed, filed, and archived to meet regulatory and customer expectations.
* Coordinate QA raw data, including Change Controls, CAPA Management, Deviation investigations, Temperature Excursion investigations, Product Discrepancy investigations, Product Recalls, and Product Quality Complaints.
* Manage QA Inbox.
* Support the Self-Inspection process.
* Support the Supplier Approvals Process.
Benefits:
* 27 days holiday plus 8 bank holidays.
* Life assurance 4 x annual salary.
* Annual salary review.
* Independent financial advice service.
* Long service awards.
* Recognition scheme & employee of the year awards.