Quality Assurance and Regulatory Affairs Associate
**Please note this is an entry level role**
Overall Purpose of the Role:
This role is to support the activities of the Quality Assurance and the Regulatory Affairs departments within Celltrion UK. Supporting to ensure Celltrion UK complies with all relevant regulatory, ethical and industry standards.
Accountability:
* Compliance with regulatory and ethical standards, ensuring adherence to regulations, guidelines and codes of practice.
* QMS management of all documents and records, including Standard Operating Procedures (SOPs) and Technical Agreements.
* Liaising with external suppliers, customers, HCPS and patients to maintain compliance.
* First line contact for internal stakeholders, to ensure cross-functional communications are efficient.
Performance Measurement:
Annual objectives will be set in conjunction with line manager. Performance will be measured during one-to-one meetings and annually using a Performance Review document.
Key Responsibilities:
Audits
* Supporting the lead auditor to prepare for all audits.
* Taking a leading role to support audits of Celltrion UK.
Processing of Product Quality complaints
* sharing with third parties and instigating investigations where relevant.
* Reconciling all complaints with third party records.
* Identifying trends and producing annual reports.
* Responding to HCPs / patients as applicable.
Legislation awareness
* Learn and be aware of the current legislation. Guidelines and other relevant technical information appropriate for the role.
Record keeping
* Maintain company training records for all employees, ensuring timelines are met for mandatory training both locally and globally.
* Maintain SOP database and manage timely reviews of all documents.
* Maintain QTA / CDA documentation and manage timely reviews of all documents.
RP & RPI support
* Review and process incoming documents, to ensure compliance with the requirements of 45AA and 45AB of the Human Medicines Regulations 2012 (as amended).
Supplier and Customer Qualifications.
* Management of Supplier & customer qualification documentation
* Conducting annual reviews and ensuring compliance.
Work Experience Requirements:
* Degree or equivalent
* Demonstrate good business acumen
* Excellent communication and interpersonal skills
* Ideally experience in the pharma industry, or similar highly regulated field.
* Team player
Core Competencies:
* Strong communication skills for interaction with internal and external stakeholders
* Data analysis and document management skill are desirable.
* Computer literacy essential
Celltrion Values:
* Creativity
* Compliance with Principles
* The Spirit of Challenge
* The Pursuit to Be the World's Best