PURPOSE & SCOPE OF THE POSITION
The Operational Compliance Officer supports the manufacturing operations by focusing on batch review and QMS on time delivery.
- Educated to degree level is essential
- Educated to degree level in Life Sciences is desired
- Experience within a regulated environment or equivalent is essential
- Working to GMP, pharmaceuticals/biologics or relevant experience within a similar environment is desired
- Ability to follow and complete manufacturing documentation accurately is essential
- Experience of a GMP controlled cleanroom environment is desirable
- Knowledge of pharmaceutical manufacture is desirable
- 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 are interested in applying for the role of Operational Compliance Officer at Symbiosis please send your CV and covering letter to Lorraine Den-Kaat by email to: Lorraine.Den-Kaat@symbiosis-pharma.com.
- Nominated manufacturing QA and QP point of contact for batch records and QMS.
- Responsible for ensuring that the facility is in an audit-ready’ state at all times.
- Perceiving problems as they develop and communicate such to the Manufacturing Manager.
- Supporting the manufacturing team by driving process improvement projects across the manufacturing department.
- Completing technical manufacturing reports / drafts for clients and provide any other supporting documentation as required.
COMPLIANCE & QUALITY MANAGEMENT
- Maintaining a clean and safe work place in accordance with GMP and Health & Safety guidance.
- Assisting in the undertaking of technical reviews associated with Corrective Action/Preventative Action (CAPA), deviations (including investigations and out of specifications).
- Undertaking the review of Batch Manufacturing Records including Component Preparation, Lyo, Visual Inspection and Labelling and Packaging.
- Perform, write and/or investigate CAPA’s and deviations.
- Ensuring training records are up to date and accurate as per current SOP revisions.
- Attend, participate and contribute to regular staff and management meetings, as necessary.
- Invest in developing relationships with all staff to fully understand staff needs and communicate the needs of the Manufacturing Manager in order that we deliver to agreed standards and timescales.
- Invest in developing relationships with the management team to ensure we are a high performing Manufacturing team and Symbiosis’ services meet expectations.
- Acting as an ambassador for the company.