Leading Pharmaceutical Manufacturer based in Cheshire seeks an experienced Senior QA Officer to help administer the Quality Management Systems. The role holder will progress batch review (prior to QP certification), deviations, change controls and other quality documents to the requirements of EU GMP and other applicable territories regulations. The role holder will assist in organisation of workload within the QA Department to support the right first-time manufacture, testing, reporting and release of pharmaceuticals.
Duties may include:
- Ensure batches are QA reviewed as required to support the business needs
- Ensure deviations, CAPA and change control for which you are the owner are progressed in a compliant and timely manner
- Ensure deviations, CAPA and change controls are reviewed and/or approved in accordance with internal procedures
- Ensure customer complaints are satisfactorily investigated and communicated
- Participate and/or host internal audits and in risk assessments
- Ensure the organisation/coordination of QAO workload is appropriate to facilitate right first-time performance and reporting/recording of the manufacturing, testing and release of pharmaceuticals.
- Ensure the effective performance of monitoring, reporting and escalation of Quality performance indicators through the QA department to the QP, Head of Quality and functional peers/leaders.
- Will support in the training and development of QAOs as required.
- Will provide guidance/advice on Quality considerations within manufacture, testing, reporting and release of pharmaceuticals as required by functional peers.
- Will support the maintenance of the site QMS and facilitate reporting of relevant KPIs within department and across site as required.
- Help conceive, define and deliver Quality related improvements projects
- Any other activity deemed quality related by the Head of Quality
Skills and experience:
- Scientific degree or significant experience with a relevant role
- Ability to read, write and follow written/verbal instructions
- Good communication skills, and ability to write reports QA Department internal performance KPIs
- Quality Management Systems performance (CAPA's, deviations, and complaints)
- Right first-time figure at QP release
- Health and safety performance - accidents and lost time
- Customer Audit performance
- Leading Pharmaceutical Manufacturer based in Cheshire seeks an experienced Senior QA Officer
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