Description
- cGMP compliance, coordinating, planning and carry out audits when required
- Batch documentation review, from GMP and company license compliance
- Support the status labelling of raw materials/product to ensure correct segregation of materials
- Issue controlled documents/work sheets as required
- Update and interrogate relevant Quality Assurance Databases
- Assist in the compilation and issue of Quality Assurance Quality Indicator Reports, including batch right first time metrics
- Assist with Batch Record Assembly
- Write Material Review Board reports and assist other departments in writing investigations summaries
* Investigate incidents of manufacturing or processing deviations or abnormal occurrences making recommendations regarding product compliance, consequent release and actions to prevent re-occurrence.
* Resolve non-conformances, CAPA's and perform product impact assessment using QRM tools.
* Comply with required standards with respect to documentation, good housekeeping, cGMP, health and safety, timekeeping, regulatory legislative requirements and in accordance with the rules and requirements of the GMP Compliance Rulebook, the Code of Conduct, quality manual and any other company policies and procedures.
* Take a position of project leadership, undertake coaching of colleagues and deliver Quality related training and development.
* Ensure Operational Excellence and Continuous improvement is integrated into the team's responsibilities. This should include adopting a philosophy of continuous improvement and a "Right First Time From Me" attitude to all operations.
* Represent QA in standing meetings, providing input, updates and guidance (including the daily batch release/production meeting).
Existing Skills and Knowledge Required:
* Demonstrable experience within Quality Assurance in a BioPharma/Pharmaceutical setting. Have significant historic evidence of independently conducting QA tasks such as Batch Release, Change Management, Status labelling, CAPA's, GMP compliance & training etc.
* Evident expertise of cGMP standards.
To find out more about Real please visit www.realstaffing.com