- Experience Level
- Experienced (non-manager)
Pharmaceutical Manufacturer requires a QA Officer for its Hertfordshire based manufacturing facility.
About the role:
To help administer the Quality Management Systems. The role holder will conduct batch release, deviations investigations, change controls and other quality documents to the requirements of EU GMP, BRC Food Safety Standard Issue 8 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 and food and beverage products.
Duties may include:
- Ensure products are fit for purpose before release for use or commercial sale.
- Maintain and improve Quality Management System performance by ensuring items such as deviations, CAPA and change control for which you are the owner are progressed in a compliant and timely manner and all other items are reviewed and/or approved in accordance with internal procedures.
- Will support the maintenance of the site QMS and facilitate reporting of relevant KPIs within department and across site as required.
- Ensure customer or supplier complaints are satisfactorily investigated and communicated.
- Participate and/or host internal and external audits inclusive of customer and regulatory audits.
- Ensure the coordination of QA workload is appropriate to facilitate right first-time performance and reporting/recording of the manufacturing, testing and release of products.
- Ensure the effective performance of monitoring, reporting and escalation of Quality performance indicators through the QA department to the Head of Quality and functional peers/leaders within.
- Will support in delivering the site GMP training as required.
- Will support in the training and development of QAOs and other staff as required.
- Support the materials management process including the qualification of suppliers for raw materials and packaging products and reviewing Technical Agreements.
- Ensure all customer requests and queries are dealt with in a timely manner in line with company procedures.
- Support in the maintenance of Validation activities across all departments.
- Support in the maintenance of HACCP in line with BRC requirements.
- Help conceive, define and deliver Quality related improvements projects.
- Any other activity deemed quality related by the Head of Quality.
Skills and experience:
- Minimum 2 years' experience in QA role in a heavily regulated GMP environment, preferably pharmaceutical or food and beverage.
- Scientific degree or relevant experience.
- Significant batch release experience.
- QMS, HACCP, Validation and Food Safety experience desirable.
- Ability to read, write and follow written/verbal instructions.
- Good communication skills, and ability to write reports.