The activities performed in the role of CQV / Manufacturing Technical Writer include: ?
Develop, review and update Standard Operating Procedures. ?
Writing of non-conformances/deviations
Use of trackwise system to monitor actions.
Involvement in quality meetings as part of coordination of specification changes that will lead to updates to SOPs.
Involvement in projects as part of continuous process improvement and / or troubleshooting, including
- Liaison with EBR process improvement team to troubleshoot and develop new ways of working
- Liaison with site training teams to enhance and develop the site procedures ?
Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current SOPs. ?
Use specified software packages and standard procedures, responsible for compiling and maintaining all relevant documentation.
Provide technical and clerical support to the QC Services team in the preparation of documentation, collation of data and tracking of SOPs ?
Contribute and assists with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits.
Requirements
Educated to degree level or equivalent. ?
Significant experience gained witJob Description
The activities performed in the role of CQV / Manufacturing Technical Writer include: ?
Develop, review and update Standard Operating Procedures. ?
Writing of non-conformances/deviations
Use of trackwise system to monitor actions.
Involvement in quality meetings as part of coordination of specification changes that will lead to updates to SOPs.
Involvement in projects as part of continuous process improvement and / or troubleshooting, including
- Liaison with EBR process improvement team to troubleshoot and develop new ways of working
- Liaison with site training teams to enhance and develop the site procedures ?
Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current SOPs. ?
Use specified software packages and standard procedures, responsible for compiling and maintaining all relevant documentation.
Provide technical and clerical support to the QC Services team in the preparation of documentation, collation of data and tracking of SOPs ?
Contribute and assists with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits.
Requirements
Educated to degree level or equivalent. ?
Significant experience gained wit
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical