The post holder will support the audit team progressing Supplier Quality Questionnaires and approving suppliers as per the audit schedules and following up internal and external audits to closure. In addition, the post holder will 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 PBL (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. ?
- To undertake relevant training. ?
- To undertake work in accordance with the PBL Health and Safety policies and procedures and to work within any Quality Systems that are applicable to the site. ?
- To comply with PBL policies and procedures.?
- Educated to degree level in Microbiology or relevant subject.
KNOWLEDGE AND EXPERIENCE
- Experience in operating quality systems in a GMP QA environment.
- Experience in auditing to GMP
- Experience of accurately preparing and/ or reviewing documents or reports.
- Practical experience in GMP manufacturing, materials control, testing, quality assurance or engineering.
- Working knowledge of ISO, GMP anad GCP.
SKILLS AND CAPABILITIES
- Problem solving skills.
- An ability to maintain confidentiality and trust.
- Clear communicator with good written and verbal, and data entry skills.
- Ability to work with a minimum of supervision and to prioritise own work load.
- Strong customer focus.
- Excellent personal effectiveness.
PORTON DOWN / WILTSHIRE / SALISBURY / BIOLOGICAL SCIENCE / CHEMISTRY / PHARMACEUTICAL / DEVELOPMENT / ANALYTICAL / EQUIPMENT / PHARMACEUTICAL PRODUCTION / REGULATORY / CONSUMABLES / QUALITY CONTROL / ENVIRONMENTAL / GMP / SUPERVISOR / TECHNICAL FILES / TECHNICAL DOCUMENTATION / FPP / cGMPs / METHODS / AUDIT / TECHNIQUES / SYSTEMS / CONSUMABLES / IDENTIFYING / EVALUATING / MATERIALS / TECHNOLOGIES / PBL / ADAPTING / POLICIES / PROCEDURES / MICROBIOLOGY / ENGINEER