Clinigen Overview
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 vital medicines are delivered securely on time and wherever needed worldwide.
We have 1,100 people headquartered in the UK with global offices in the US, EU, JAPAC, and South Africa. Clinigen has grown rapidly since 2010 and is well-positioned for an exciting future of continued expansion.
Job Title: Quality Specialist and Deputy RP
To support our growth, we are seeking a confident and proactive Quality Specialist and Deputy RP to join us, working directly with the Quality Manager to support the business in relation to all quality matters detailed below.
Key Responsibilities:
* Follow, Promote, and Enforce Relevant SOPs: Adhere to and enforce relevant Standard Operating Procedures (SOPs), Job Aids, and Company policies and procedures.
* Maintain GMP and GDP Standards: Assist in ensuring that the appropriate standards of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) are maintained.
* Quality Documentation: Originate, review, approve, maintain, and archive quality documentation, including Policies, SOPs, etc.
* Training and Support: Assist in organizing and delivering training in this area.
* QA Raw Data: Coordinate Quality Assurance raw data to ensure compliance with regulatory expectations.
* QMS Reporting: Collate raw data to support monthly Quality Management System (QMS) reporting.
* QA Projects: Contribute to the delivery of QA projects as required.
* Enquiries and Compliance: Deal with QA enquiries promptly and with due diligence.
* Document Management: Ensure all quality-critical documents are appropriately drawn up, maintained, reviewed, filed, and archived to ensure compliance with regulatory and customer expectations. Provide reports to the group head of Quality, Quality Manager, and other nominated parties to show status and progress.
* Change Control and CAPA: Coordinate QA raw data, including Change Controls, CAPA Management, Deviation investigations, Temperature Excursion investigations, Product Discrepancy investigations, Product Recalls, and Product Quality Complaints.
* QA Inbox Management: Manage QA Inbox.
* Self-Inspection Process: Support the Self-Inspection process.
* Supplier Approvals Process: Support the Supplier Approvals Process.
Benefits:
* Holiday Allowance: 27 days holiday plus 8 bank holidays.
* Life Assurance: 4 x annual salary.
* Annual Salary Review: Annual salary review.
* Independent Financial Advice: Independent financial advice service.
* Long Service Awards: Long service awards.
* Recognition Scheme: Recognition scheme & employee of the year awards.