Industry: Pharmaceutical Production / Operations / Product Support
Salary: Up to £27.2k
Training: Yes (Full).
The post holder will support the product Quality manager to provide the QA oversight confirming that activities in manufacturing and testing areas are performed to procedures, to GMP requirements, with the appropriate data integrity compliance. The post holder will provide advice to operational areas and may be required to coach staff as required.
MAIN DUTIES AND RESPONSIBILITIES
- To provide quality oversight of manufacturing, testing, and other activities supporting pharmaceutical manufacture.
- To observe critical activities in real time and confirm compliance/address issues.
- To provide GMP and data integrity advice to staff as required, promote and enforce best practice.
- To coach staff to Quality, GMP and data integrity procedures as required.
- To help resolve at the bench low level issues in the local areas.
- To escalate issues to management.
- To perform routine review of documents such as log books
- To promote the PBL quality culture site wide.
- To undertake relevant training.
- 10.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 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 a specialist area
KNOWLEDGE AND EXPERIENCE
Experience in operating quality system(s) in a GMP QA environment with proven experience of encountering a wide range of situations.
Good knowledge of GMP, aseptic manufacture and data integrity requirements
Practical experience in GMP Biopharmaceutical manufacture, testing or engineering, with proven evidence of encountering a wide range of situations.
Experience in training/troubleshooting small groups of staff.
SKILLS & CAPABILITIES
- Excellent proven communication, tenacity and interpersonal skills.
- Ability to work with a minimum of supervision and to prioritise own work.
- Strong internal customer focus.
- Excellent personal effectiveness.
- Confident approach and leadership
- Flexible approach in line with manufacturing and testing schedule
- High level of personal integrity
- Eye for detail
PORTON DOWN / WILTSHIRE / SALISBURY / MANUFACTURING / PRODUCT / PHARMACEUTICALS / GMP / DATA INTEGRITY / PBL / MICROBIOLOGY / ASEPTIC MANUFACTURE / MANAGEMENT / ENGINEERING / BIOPHARMACEUTICAL / TESTING / LEADERSHIP / PROMOTE / DOCUMENTS / QUALITY SYSTEMS / PROCEDURES /
- Product Development