Excellent opportunity for an experienced Compliance Officer coming from a QA background to work with a growing Pharmaceutical company
Job Title: QA Compliance Officer
Reference No: 240914
Job Type: Permanent
Salary: circa £29,000
The role will be to support the audit team in progressing Supplier Quality Questionnaires and approving suppliers as per the audit schedules and following up internal and external audits to closure. You will also review Monographs and TSE/BSE statements for the approval of suppliers, produce Quality Technical Agreements with critical suppliers and initiate and progress Supplier Complaints.
MAIN DUTIES AND RESPONSIBILITIES
To review new supplier request forms.
To send and review supplier quality questionnaires and ensure they are satisfactorily completed by key manufacturers and suppliers in a timely fashion.
To liaise with suppliers to obtain relevant information for their approval to provide key materials and services to the Company (incl. processing, BSE/TSE).
To approve GMP Monographs to ensure that suppliers are appropriately approved and BSE/TSE certificates are satisfactory.
To assist in the production of Quality Technical Agreements for the supply of goods and services from critical suppliers.
To initiate and progress Supplier Complaints to closure.
To update the supplier monitoring database and associated spread sheets used for tracking.
To follow up open audit reports and review evidence in order to close out audit reports.
To assist with the QA overview of manufacturing and testing areas.
Qualification - Desirable
Educated to degree level or HND in relevant subject (e.g. Microbiology, or a related subject) or a demonstrable equivalent level of experience of working at a similar level in specialist area
Membership of IQA, RQA or equivalent
Knowledge and experience - Essential
Experience in operating quality system(s) in a GMP QA environment
Experience in auditing to GMP
Extensive experience of using an eQMS system in a QA environment
Experience in training/troubleshooting small groups of staff
Knowledge and experience - Desirable
Experience of accurately preparing and/or reviewing documents or reports in a timely fashion.
Practical experience in GMP manufacturing, materials control, testing, quality assurance or engineering.
Working knowledge of ISO, GMP, GCP and other GxPs