PURPOSE & SCOPE OF THE POSITION
The Quality Control Officer supports the Quality Department and specifically the Quality Control (QC) function within Symbiosis and ensuring sampling, specifications and testing as well as the organisation, documentation and release procedures which ensure that the necessary and relevant tests are carried out. And ensuring adherence to all developed quality systems and promoting continual development of quality systems where necessary.
- Educated to degree level in Life Sciences
- IT skills – Microsoft packages
- Experience with QC release testing
- Experience with environmental monitoring of GMP cleanrooms
- Effective communication skills
- Flexible and adaptive team player
- Ability to perform multiple tasks effectively in a busy environment
- Effective planning and organisational skills
If you would like to apply for this role, please send your CV and cover letter, detailing your salary requirements to email@example.com
Operational Quality Assurance
- Contributing to the continual development of quality systems, in particular those relating to QC activities of the Quality Department.
- Reviewing and approving data such as Environmental Monitoring and QC testing, including: data entry and extraction, report preparation, document handling, notification of Out of Specification results to the PQO.
- Assisting with stability study management and in-house QC analysis and reporting.
- Approving and releasing incoming Raw Material
- Completing QMS administration for QC related issues including Out of Specification and environmental monitoring excursions investigations.
- Supporting the implementation of updated or new QC procedures throughout the company including the provision of training and other support across the Symbiosis organisation.
- Supporting analytical method technical transfer and validation as per appropriate regulatory guidance.
- Supporting the ongoing maintenance and management of subcontract facilities used within Symbiosis including audit management, maintenance of agreements and performance review.
- Supporting the maintenance and provision of QC related trend data as required by Symbiosis quality review processes and regulatory authorities.
- Supporting the Project Management function in the communication and consultation with external laboratories as required for testing subcontracted on behalf of Symbiosis clients.
- Undertaking monthly data integrity checks
- Providing regulatory support regarding QC analysis through consultation of the appropriate information sources eg GMP guides and Pharmacopoeias
- Develop, monitor, improve and maintain procedures to ensure compliance with EU/FDA Good Manufacturing Practice for the manufacture and testing of pharmaceuticals
- Ensuring completion of all relevant QMS including management of non-conformances, corrective and preventative actions, change management, risk assessment and audit responses
- Providing QC coaching/guidance for cross functional groups to ensure compliance.
- Coordinating and providing training across functional groups in Quality procedures, cGMP requirements, and QA concepts.
- Providing support to management during third party audits.
- Train staff in QC related procedures and concepts as directed by the Quality Control Manager and Quality Director
- Attending, participating and contributing to regular staff meetings, as necessary.
- Investing in developing relationships with all staff
- Investing in developing relationships with the management team to ensure we are a high performing team and Symbiosis’ services meet expectations.
- Acting as an ambassador for the company.