Quality Assurance Documentation Officer (a1WNz0000001jzCMAQ) Cwmbran, Wales
| Salary: | GBP12.65 - GBP13.65 per hour |
Job Role : QA Documentation Officer
Salary : £12.65 per hour
Hours - Monday - Friday
Shift 1 - Monday - Friday 6.00 - 14.00
Shift 2 Monday - Thursday 13.30 - 21.30 Friday 10.00 - 18.30
Job Role:
As a QA Documentation Officer you will report directly to the Documentation Co-ordinator. The Documentation Officer supports the provision, and subsequent review, of all documentation to the manufacturing environment. You play a critical role in supporting the development of a Quality culture within the business.
Responsibilities:
* The review of manufacturing batch records to ensure they are completed to a GMP standard; communicating any issues with colleagues in a timely manner, where required
* The certification and release of finished goods, including the creation and issuing of certificates of analysis, certificates of conformance or any other documentation required for the batch release process to customers.
* Preparation, maintenance, issuance, and distribution of documents (on paper, electronically or as hybrid documents) for the support of operational activities; including document change control, product modifications, process deviations and manufacturing logbooks.
* Participation in the resolution of operational issues by providing technical support for any documentation issues that arise during manufacturing activities, seeking guidance from Quality Management where necessary
* Ensuring that incoming enquiries to the Quality department are dealt with appropriately and professionally, and redirected where appropriate
* Liaising with the quality management team to ensure documentation always meets regulatory expectations for continued compliance.
* Filing, archival, retrieval of documentation and general administrative duties to support the Quality department.
* To create a positive environment in the QA office, and to take ownership for your own performance and continual professional development.
* To ensure effective communication, co-operation and cohesion between colleagues on the other QA shifts and other company departments.
Requirements:
Minimum of 5 GCSEs at grades 9 to 4 (A* – C), including English and Maths.
Good level of computer literacy: Microsoft Office 365 package software, Q-Pulse, Navision
* Understanding of the good documentation requirements of Good Manufacturing Practice (GMP)
* Confident in communicating and interacting with all levels of internal stakeholders
* Excellent personal organisational skills
* Attention to detail
* Enthusiasm, personal drive and initiative
* Friendliness and approachability
* Flexibility in adapting to changing circumstances and handling new situations
* To ensure the office areas are maintained and kept in a clean and tidy state.
* To operate and abide by safe practices at all times.
* To report accidents and near misses/matters of concerns immediately.
Salary : £12.65 per hour
Hours - Monday - Friday
Shift 1 - Monday - Friday 6.00 - 14.00
Shift 2 Monday - Thursday 13.30 - 21.30 Friday 10.00 - 18.30
Job Role:
As a QA Documentation Officer you will report directly to the Documentation Co-ordinator. The Documentation Officer supports the provision, and subsequent review, of all documentation to the manufacturing environment. You play a critical role in supporting the development of a Quality culture within the business.
Responsibilities:
* The review of manufacturing batch records to ensure they are completed to a GMP standard; communicating any issues with colleagues in a timely manner, where required
* The certification and release of finished goods, including the creation and issuing of certificates of analysis, certificates of conformance or any other documentation required for the batch release process to customers.
* Preparation, maintenance, issuance, and distribution of documents (on paper, electronically or as hybrid documents) for the support of operational activities; including document change control, product modifications, process deviations and manufacturing logbooks.
* Participation in the resolution of operational issues by providing technical support for any documentation issues that arise during manufacturing activities, seeking guidance from Quality Management where necessary
* Ensuring that incoming enquiries to the Quality department are dealt with appropriately and professionally, and redirected where appropriate
* Liaising with the quality management team to ensure documentation always meets regulatory expectations for continued compliance.
* Filing, archival, retrieval of documentation and general administrative duties to support the Quality department.
* To create a positive environment in the QA office, and to take ownership for your own performance and continual professional development.
* To ensure effective communication, co-operation and cohesion between colleagues on the other QA shifts and other company departments.
Requirements:
Minimum of 5 GCSEs at grades 9 to 4 (A* – C), including English and Maths.
Good level of computer literacy: Microsoft Office 365 package software, Q-Pulse, Navision
* Understanding of the good documentation requirements of Good Manufacturing Practice (GMP)
* Confident in communicating and interacting with all levels of internal stakeholders
* Excellent personal organisational skills
* Attention to detail
* Enthusiasm, personal drive and initiative
* Friendliness and approachability
* Flexibility in adapting to changing circumstances and handling new situations
* To ensure the office areas are maintained and kept in a clean and tidy state.
* To operate and abide by safe practices at all times.
* To report accidents and near misses/matters of concerns immediately.