PURPOSE & SCOPE OF THE POSITION
The Quality Assurance Document Reviewer contributes to developing Symbiosis’ mutually beneficial relationships by supporting the manufacturing operations by focusing on batch review and QMS on time delivery.
- Educated to a degree level
- Educated to a degree level in Life Sciences
- IT skills – Microsoft packages
- Experience in Electronic Quality Management Systems
- Experience in a GMP manufacturing environment
- Experience in a service company and with a very strong client orientation
- Effective communication skills
- Flexible and adaptive team player
- Ability to perform multiple tasks effectively in a busy environment
- Effective planning and organisational skills
- Nominated manufacturing and QP point of contact for batch record review to support batch release.
- Maintain a status tracker and provide accurate status reports on batch record review to support batch compilation activities.
- Perceive problems as they develop and communicate such to the Quality Assurance Manager.
Compliance and Quality Management
- Maintain a clean and safe work place in accordance with GMP and Health & Safety guidance.
- Undertake the review of Batch Manufacturing Records including Component Preparation, Lyo, Visual Inspection and Labelling and Packaging ensuring compliance of manufacturing activities against approved manufacturing technical agreements and Symbiosis SOP’s as directed by the Quality Assurance Manager and Quality Director.
- Attend, participate and contribute to regular staff meetings, as necessary.
- Invest in developing relationships with all staff.
- Invest in developing relationships with the management team to ensure we are a high performing team and Symbiosis’ services meet expectations.
- Act as an ambassador for the company.